| Text of
Printed Hearing The Committee on Energy and Commerce W.J. "Billy" Tauzin, Chairman Continuing Concerns Over Imported Pharmaceuticals <DOC>
[107th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:73737.wais]
CONTINUING CONCERNS OVER IMPORTED PHARMACEUTICALS
=======================================================================
HEARING
before the
SUBCOMMITTEE ON
OVERSIGHT AND INVESTIGATIONS
of the
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
__________
JUNE 7, 2001
__________
Serial No. 107-30
__________
Printed for the use of the Committee on Energy and Commerce
Available via the World Wide Web: http://www.access.gpo.gov/congress/
house
__________
U.S. GOVERNMENT PRINTING OFFICE
73-737CC WASHINGTON : 2001
COMMITTEE ON ENERGY AND COMMERCE
W.J. ``BILLY'' TAUZIN, Louisiana, Chairman
MICHAEL BILIRAKIS, Florida JOHN D. DINGELL, Michigan
JOE BARTON, Texas HENRY A. WAXMAN, California
FRED UPTON, Michigan EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida RALPH M. HALL, Texas
PAUL E. GILLMOR, Ohio RICK BOUCHER, Virginia
JAMES C. GREENWOOD, Pennsylvania EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia SHERROD BROWN, Ohio
STEVE LARGENT, Oklahoma BART GORDON, Tennessee
RICHARD BURR, North Carolina PETER DEUTSCH, Florida
ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois
GREG GANSKE, Iowa ANNA G. ESHOO, California
CHARLIE NORWOOD, Georgia BART STUPAK, Michigan
BARBARA CUBIN, Wyoming ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois TOM SAWYER, Ohio
HEATHER WILSON, New Mexico ALBERT R. WYNN, Maryland
JOHN B. SHADEGG, Arizona GENE GREEN, Texas
CHARLES ``CHIP'' PICKERING, KAREN McCARTHY, Missouri
Mississippi TED STRICKLAND, Ohio
VITO FOSSELLA, New York DIANA DeGETTE, Colorado
ROY BLUNT, Missouri THOMAS M. BARRETT, Wisconsin
TOM DAVIS, Virginia BILL LUTHER, Minnesota
ED BRYANT, Tennessee LOIS CAPPS, California
ROBERT L. EHRLICH, Jr., Maryland MICHAEL F. DOYLE, Pennsylvania
STEVE BUYER, Indiana CHRISTOPHER JOHN, Louisiana
GEORGE RADANOVICH, California JANE HARMAN, California
CHARLES F. BASS, New Hampshire
JOSEPH R. PITTS, Pennsylvania
MARY BONO, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska
David V. Marventano, Staff Director
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Oversight and Investigations
JAMES C. GREENWOOD, Pennsylvania, Chairman
MICHAEL BILIRAKIS, Florida PETER DEUTSCH, Florida
CLIFF STEARNS, Florida BART STUPAK, Michigan
PAUL E. GILLMOR, Ohio TED STRICKLAND, Ohio
STEVE LARGENT, Oklahoma DIANA DeGETTE, Colorado
RICHARD BURR, North Carolina CHRISTOPHER JOHN, Louisiana
ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois
Vice Chairman JOHN D. DINGELL, Michigan,
CHARLES F. BASS, New Hampshire (Ex Officio)
W.J. ``BILLY'' TAUZIN, Louisiana
(Ex Officio)
(ii)
C O N T E N T S
__________
Page
Testimony of:
Christian, James, Vice President and Head of Global Corporate
Security, Novartis International........................... 157
deKieffer, Donald, deKieffer & Horgan........................ 173
Durant, Elizabeth G., Executive Director of Trade Programs,
U.S. Customs Service....................................... 40
Gibbs, Landon S., First Sergeant, Virginia State Police...... 58
Glover, John D., Vice President, Corporate Security, Bristol-
Myers Squibb Company....................................... 153
Haislip, Gene R., Consultant................................. 166
Hubbard, William K., Senior Associate Commissioner for
Policy, Planning and Legislation, Food and Drug
Administration............................................. 45
Leshner, Alan I., Director, National Institute on Drug Abuse. 55
Nagel, Laura M., Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration......... 37
Rode, Rev. Edwin and Helen................................... 24
Shepherd, Marvin, Professor, College of Pharmacy, University
of Texas................................................... 146
Trundley, William, Vice President of Corporate Security
Investigations, GlaxoSmithKline............................ 163
Vereen, Donald R., Jr., Deputy Director, Office of National
Drug Control Policy........................................ 33
(iii)
CONTINUING CONCERNS OVER IMPORTED PHARMACEUTICALS
----------
THURSDAY, JUNE 7, 2001
House of Representatives,
Committee on Energy and Commerce,
Subcommittee on Oversight and Investigations,
Washington, DC.
The subcommittee met, pursuant to notice, at 10 a.m., in
room 2123, Rayburn House Office Building, Hon. James C.
Greenwood, (chairman) presiding.
Members present: Representatives Greenwood, Bilirakis,
Stearns, Gillmor, Largent, Burr, Whitfield, Bass, Deutsch,
Stupak, DeGette, and Dingell (ex officio).
Staff present: Alan Slobodin, majority counsel; Ray
Shepherd, majority counsel; Will Carty, legislative clerk; and
Chris Knauer, minority counsel.
Mr. Greenwood. Good morning. A quorum being present, this
hearing of the Oversight and Investigations Subcommittee of the
House Energy and Commerce Committee will come to order.
The Cambridge Dictionary of American English defines the
word ``huckster'' as a person who sells things or puts forward
ideas in a very determined way that is often not completely
honest.
Sadly, there is a long and infamous history of hucksterism
in America. Today, we are here to examine the latest
incarnation of this unscrupulous practice of selling people
what they either don't need or shouldn't buy. In this case, it
is the sale of unapproved mis-branded or adulterated drugs.
Usually ineffectual, and often unsafe, and increasingly
over the Internet, the disreputable promoters of these illicit
products have added a new twist to the way that modern day
stake oil salesmen prey on the needy and the unsuspecting.
Their model might very well might be there is a sucker
logging on every minute. A few weeks ago, Congressmen Deutsch,
Stupak, and I visited the international mail facility near
Dulles Airport, and what we found was truly frightening.
And these are some examples of the drugs that we found.
This one is labeled, ``Jungle Juice.'' It is amyl nitrite and
it is a drug that is abused, usually by young people on dance
floors I am told, and in discos.
This is a vial of drugs. It is a powder labeled, ``Gamma
hydroxybuterate.'' We have no idea what it really is. We found
all kinds of pills, and a virtual drug cabinet full of all
kinds of products; steroids, illegal drugs, legal drugs,
misbranded drugs, all very dangerous to the American public.
Overall, I believe that prescription drugs in the U.S. are
extremely safe, but it is important to remember that the risk
is not zero. There is no magic force-field that protects the
U.S. from imported counterfeit or diverted products.
We must be aware of the latest threats in the global
pharmaceutical market and we must deal with them. Perhaps
nothing more clearly illustrates the dangers of drug
importation than the evidence turned up in a joint U.S. and
Thai customs enforcement effort in March 2001.
Called Operation Chokepoint, it shows what lurks behind
some of these foreign based Internet pharmacies. This operation
targeted thousands of illegal pharmaceutical shipments of
viagra and steroids exported from Thailand by mail from a
notorious Internet pharmacy to U.S. customers.
The results of the operation showed a British national,
still under treatment for hepatitis, operating an illegal
pharmaceutical processing center in his residence, processing
the drugs in a filthy, vermin infested kitchen.
Representatives in the U.S. Congress enact the laws to
protect consumers from the dangers of unapproved, misbranded,
or adulterated drugs. As such Representatives, we have a
responsibility to raise public awareness about these risks, and
to put an end to them.
The subcommittee is particularly concerned about the
dangers of personal importation. In 1998, in response to
concerns about the personal importation of controlled
substances at the Mexican land border, the Congress enacted
legislation that required a valid U.S. prescription for any
personal import of a controlled substance that was more than 50
dosage units.
Unfortunately, it appears from the committee's staff's
investigation that this 50 dosage unit policy has become well
known and exploited by drug traffickers. One can even find
controlled substances blister-packed in 50 dosage units
amounts.
Consider also the massing of pharmacies that provide easy
access to controlled substances at our southern borders. For
example, in Tijuana, Mexico, it is estimated that there are
approximately 1,700 pharmacies.
In contrast, 20 miles north in San Diego, California, which
has roughly the same population, there are 125 pharmacies.
Clearly, there is a need to further strengthen Federal policy
in the area of personal imports of controlled substances.
I want to note my particular appreciation to Congressman
John Dingell, the ranking member of the full committee, for
forcefully raising this important public safety and public
health issue.
Mail deliveries represent another personal importation
problem. In January and February of 2001, the FDA conducted a
pilot program with the Customs Service on mail deliveries of
prescription drugs at the international mail facility at Los
Angeles.
The FDA was only able to review 1,908 of nearly 16,000
parcels that came in, roughly 12 percent. Out of these, 554
were ultimately refused entry. A large percentage of the 554
refused entries were shipped via a South Pacific Republic
called Vanuatu.
It is believed that those shipments were from a single
source currently under criminal investigation. Extrapolating
from the pilot program data nationally, it is estimated that up
to 200,000 parcels per month could be coming into the U.S.
unexamined.
Clearly, a serious policy decision needs to be made and new
procedures instituted. What are the dangers of the prescription
drugs that are allowed in? We will hear of one tragic story
from Edwin and Helen Rode.
I want to thank Reverend and Mrs. Rode for testifying at
this hearing. It takes a lot of courage to relate their painful
experience publicly, but by stepping forward, they hope to save
the lives of others.
But what about unsuspecting customers who are getting drugs
within the U.S. health care delivery system? What are the risks
to them of purchasing counterfeit or substandard drugs? Recent
events in the U.S. pharmaceutical market have justified this
subcommittee's vigilance over counterfeiting.
Last month, three different drug companies reported finding
counterfeit versions of their drugs in the U.S. One bogus drug
was for treating patients with AIDS wasting disease, a
particular vulnerable population.
So far there do not appear to be any life threatening
adverse events linked to the counterfeits, but they did make
their way on to pharmacy shelves and into patient's medical
cabinets.
I want to thank the Chairman of the Energy and Commerce
Committee, Congressman Billy Tauzin, for his support of this
investigation, and hearing about imported drugs. I also want to
thank the ranking minority member of the subcommittee,
Congressman Peter Deutsch, for his support and interest in this
investigation.
Likewise, I express my appreciation to Congressman Bart
Stupak for his particular participation and contribution to
this subcommittee's efforts. I am well aware of the hard work
and the preparation for these hearings by all of the witnesses
on behalf of the subcommittee, and I thank you and I look
forward to your testimony.
[The prepared statement of Hon. James C. Greenwood
follows:]
Prepared Statement of Hon. James C. Greenwood, Chairman, Subcommittee
on Oversight and Investigations
introduction
When the subject is pharmaceuticals, people usually talk about the
high prices. But today's hearing will show we still also need to pay
attention to safety.
We in Congress are acutely aware of the problem of high prices of
prescription drugs in the U.S. About a third of our elderly are without
access to adequate prescription drug coverage. Many Americans,
especially our senior citizens on fixed incomes, struggle to balance
their finances to pay for prescription drugs that help keep them alive
or maintain a decent quality of life.
Out of these desperate circumstances, some cash-strapped Americans
are traveling to border pharmacies to obtain what they believe are
cheaper versions of the U.S. drugs in Mexico or Canada. Some Americans
are ordering drugs through the mail from foreign-based internet
pharmacies to obtain prescription drugs without real physician
supervision. Perhaps it is a measure of the success of the high
regulatory and industry standards in the U.S. that many Americans in
their pursuit of affordable medicine appear to take the safety of
prescription drugs for granted.
However, what we will learn today, is that drugs obtained from
outside the United States without proper controls pose real risks to
American consumers. This hearing will examine these risks by focusing
on four particular areas of continuing concerns over imported
pharmaceuticals:
1. controlled substances from Mexican border pharmacies;
2. prescription drugs ordered from foreign-based internet pharmacies;
3. counterfeit or substandard bulk drugs; and
4. international pharmaceutical counterfeiting and diversion.
In all of these areas, there is a mass of evidence from studies and
investigations that shows the safety risks. I understand that some
Americans who feel desperate are willing to take risks purchasing
prescription drugs from a border pharmacy or a foreign-based internet
pharmacy. Under current circumstances, I don't want to interfere with
seniors who are desperately looking for cheaper buys. But I feel sure
that many senior citizens don't want to see their grandchildren harmed
by controlled substances from border pharmacies or drugs obtained
without a prescription from some phantom, foreign website.
Recent events in the U.S. pharmaceutical market have justified the
Subcommittee's vigilance over counterfeiting. Last month, three
different drug companies reported finding counterfeit versions of their
drugs in the U.S. One bogus drug was for treating patients with AIDS
wasting disease, a particularly vulnerable population. Another
counterfeit purported to be a growth hormone that contained human
insulin, which could be deadly to some individuals. The third fake drug
was labeled as an anti-infective that had no active ingredient. So far,
there do not appear to be any life-threatening adverse events linked to
the counterfeits, but they did make their way to pharmacy shelves.
We have a responsibility to raise public awareness about the
dangers of unapproved, misbranded or adulterated drugs, these risks,
and to help minimize these risks through public education, working with
the Administration to take sensible and restrained administrative
actions, and passing new legislation, if necessary. I want Americans to
get cheaper prescription drugs in the U.S. I don't want any Americans
hurt in trying to get cheaper drugs from abroad.
background: the food, drug & cosmetics act
Prescription drugs are highly regulated and require physician
supervision for a reason. Drugs are inherently dangerous unless they
are manufactured precisely and properly, dosed correctly, and used
appropriately. When used under competent physician care and in
accordance with instructions, drugs are life-saving. But there is often
not a large margin between life and death.
For these reasons and others, it is illegal under the federal Food,
Drug and Cosmetic Act to import misbranded, adulterated or unapproved
prescription drugs. However, in a bow to common sense, the FDA decided
over 40 years ago not to strictly enforce the Act against U.S.
residents who obtained unapproved foreign-made prescription drugs to
treat sickness or injury while on travel in a foreign country. Over
time FDA created a guidance on personal importation of prescription
drugs that in effect says for reasons of enforcement priorities and
limited resources, FDA will not enforce the Act against U.S. residents
who bring in a 90-day supply of foreign drugs for medical purposes
either from traveling abroad or through mail delivery.
With regard to personal importation, the Subcommittee is
particularly concerned about two areas: (1) controlled substances
obtained at the land border pharmacies (especially Mexico), and (2)
prescription drugs obtained through mail deliveries. Controlled
substances represent the most dangerous class of prescription drugs,
because they can be addicting, and even deadly when used non-medically.
Because of their high abuse potential, these prescription drugs are
scheduled under federal law requiring additional regulation.
border crossings
In 1998, in response to concerns about the personal importation of
controlled substances at the Mexican land border, the Congress passed
an amendment to the Controlled Substances Import and Export Act. That
amendment required a valid U.S. prescription for any personal import of
a controlled substance that was more than 50 dosage units. Perhaps
sensing that this 50-dosage unit law represented an opportunity for
clearer guidance to overwhelmed Customs border inspectors, some in the
Customs Service interpreted the 1998 amendment as justifying an
enforcement practice that would allow personal imports of 50 dosage
units or less for each drug per border crossing.
Unfortunately, it appears from the Committee staff's investigations
at the Southwest border crossings, internet postings and chat rooms,
and other information, that this 50-dosage unit policy has become well-
known and exploited by drug traffickers and individuals interested in
bringing in controlled substances for abuse purposes. One can even find
controlled substances blister-packed in 50-dosage unit amounts.
Although we lack comprehensive and definitive data on controlled
substances importation, it is reasonable to observe that the 50-dosage
unit policy is contributing to a national drug abuse problem. Consider
the massing of pharmacies that provide easy access to controlled
substances at our borders. For example, in Tijuana, Mexico, there are
estimated to be up to 1700 pharmacies, up from 500 pharmacies in 1997.
In contrast, twenty miles north, in San Diego, California, there are
only 125 pharmacies.
In December 2000, the Texas Commission on Alcohol and Drug Abuse
noted that a major substance abuse problem is Mexican pharmacies
selling many controlled substances to U.S. citizens who declare these
drugs and bring in personal import amounts into Texas. We will hear
testimony from Landon Gibbs of the Virginia State Police about the
emerging abuse problem of one controlled substance called oxycontin, a
powerful painkiller drug with a 12-hour time-release targeted by drug
traffickers because of the huge narcotic rush when the drug is crushed
and snorted. Although the vast majority of abuse cases involves drug
unlawfully obtained within the U.S., recent investigations indicate
some oxycontin is coming from Mexico, probably some through personal
importation from Mexico.
In response to the Committee's bipartisan concerns, several federal
agencies--the Office of National Drug Control Policy, the Drug
Enforcement Administration, the FDA, and the Customs Service--have been
meeting to develop recommendations for strengthening federal policy in
the area of personal imports of controlled substances. I understand
that the Drug Enforcement Administration has developed a proposal that
we hope to be a vast improvement over the status quo. I look forward to
hearing about this proposal and discussion of this issue with our
witnesses. I want to note my particular appreciation to Congressman
John Dingell, the Ranking Member of the Full Committee, for forcefully
raising this important public safety and public health issue.
mail deliveries
Mail deliveries represent another personal importation problem. In
the last few years, especially with the explosion of internet
pharmacies, personal mail deliveries of prescription drugs have
skyrocketed, overwhelming the Customs Service and the FDA. In January-
February 2001, the FDA conducted a pilot program with the Customs
Service on mail deliveries of prescription drugs at the international
mail facility at Los Angeles.
Typically, the Customs Service screens the parcels by sight and
through an x-ray machine. Customs sets aside the parcels of
prescription drugs for an FDA officer to review. The FDA officer
usually comes for a half-day, once a week, to review the parcels. Under
the pilot program, two FDA officers were on-site, five-days a week,
processing the set-aside parcels for 30 days. Even under these ideal
circumstances, FDA was only able to review 1,908 parcels out of a
possible 16,000 or only about 12% of the likely universe of
prescription-drug parcels. Out of these parcels, FDA detained about 700
out of the 1900, because they appeared violative. Out of the 700
detained parcels, 554 were ultimately refused entry, usually because it
was determined that the mail order lacked a valid prescription. A large
percentage of the 554 refused entries were shipped via a South Pacific
republic called Vuanuatu and New Zealand. It is believed that those
shipments were from a single source currently under criminal
investigation. It is important to note that the parcels that FDA is
unable to review are released. Extrapolating from the pilot program
data nationally, it is estimated that up to 200,000 parcels per month
could be coming in unreviewed.
In September 2000 the Customs Service conducted a study called
Operation Safeguard of two U.S. facilities showed that none of the
pharmaceuticals examined were reimportations of U.S. manufactured
drugs. None of the 512 parcels fulfilled all the personal use
requirements. Only three parcels had evidence of medical supervision
and ten percent of the parcels analyzed contained no active
ingredients.
What are the dangers of the prescription drugs that are allowed in?
We will hear of one tragic story from Edwin and Helen Rode. Their son,
Todd, was found dead on November 16, 1999. They believe his death was a
direct result of prescription drugs obtained through the mail from a
foreign-based internet pharmacy. Although Todd was being treated for
severe depression, he ordered a combination of prescription drugs
without any physical examination by a physician. The medical examiner's
report states that some of these drugs were ingested by Todd at the
time of his death. I want to thank Reverend and Mrs. Rode for
testifying at this hearing. It takes a lot of courage to relate their
painful experience publicly. But by stepping forward, they may help
save some lives.
o&i field trip to dulles airport
Just a few weeks ago, Congressmen Deutsch, Stupak, and I visited
the international mail facility near Dulles Airport. We viewed
firsthand the processing of prescription drug parcels. Here is one
example. Many of these parcels contained prescription drugs that had
been withdrawn from the US market, highly dangerous combinations of
drugs for one person, drugs lacking labeling or instructions, drugs
masked as something else or not in its original container. The
overwhelming numbers of prescription-drug parcels is a daunting
challenge, that would require a tremendous and unrealistic increase in
personnel and resources. Even if such an increase occurred, the legal
requirements in processing parcels impose massive burdens. Clearly, a
serious policy decision needs to be made and new procedures considered.
In response to a bipartisan inquiry in this area, the FDA in
consultation with the Customs Service has devised several proposals for
improving the public health protections related to mail deliveries.
These proposals and a recommendation are pending with the Secretary of
Health and Human Services. I look forward to working with the Secretary
to move in a reasonable and responsible way.
In the area of personal importation, individuals usually are in
some way assuming some risk. But what about unsuspecting consumers who
are getting drugs within the U.S. healthcare delivery system? Are there
any risks to them of getting counterfeit or substandard drugs? Over the
last decade, there has been a surge in shipments of bulk drugs or
``active pharmaceutical ingredients'' (APIs) from overseas. About 70-
80% of brand-name APIs and 90-95% of generic APIs are made overseas.
Any foreign firm that makes bulk ingredients for the U.S. market must
be inspected by the FDA. This surge of imports has overwhelmed FDA and
outstripped its inspectional resources. Last year, the FDA advised the
Committee that 242 foreign API firms appeared to have shipped
misbranded drugs to the U.S. in 1999 but were never inspected by the
FDA.
Even for those firms that have been inspected, the Subcommittee's
past investigations have shown how the approved foreign firm in a few
cases becomes the front for counterfeit or unapproved bulk drugs
shipped to the U.S. Sophisticated counterfeiting in the chemistry and
documentation of the drugs is difficult to detect. Last year's
Subcommittee hearing revealed a link between serious reactions in a 155
American patients from an antibiotic and a Chinese bulk drug
manufacturer. The FDA committed to a number of strategies for handling
imported counterfeit and unapproved drugs. The Subcommittee will want
to learn how the FDA has approved its intelligence gathering on
counterfeiting. We will want to find out how the FDA plans to use its
personnel and equipment to better monitor U.S. ports of entry. We are
also interested in what, if any, security measures FDA has added and
what additional resources may be needed.
Overall, prescription drugs in the U.S. are extremely safe. But it
is important to remember that the risk is not zero. There is no magic
force-field that protects the U.S. from imported counterfeit or
diverted product. We must be aware of the latest threats in the global
pharmaceutical market and deal with them. We are very fortunate to have
some of the leading experts on pharmaceutical counterfeiting and
diversion before us today. Their testimony should greatly assist the
Subcommittee's understanding of the issues.
I want to thank the Chairman of the Energy and Commerce Committee,
Congressman Billy Tauzin, for his support of this investigation and
hearing about imported drugs. I also want to thank the Ranking Minority
Member of the Subcommittee, Congressman Peter Deutsch, for his support
and interest in this investigation. I likewise express my appreciation
to Congressman Bart Stupak for his participation and contribution to
the Subcommittee's efforts.
I am well aware of the hard work and the preparation for these
hearings by all of the witnesses. On behalf of the Subcommittee, I
thank you and look forward to your testimony.
Mr. Greenwood. With that, the Chair yields 5 minutes to the
ranking member of the full committee, Mr. Dingell.
Mr. Dingell. Thank you. I commend you for holding this
hearing. I am saddened that we are again having to relearn the
lessons that should be all too familiar to this Congress and to
the subcommittee.
I will not elaborate on why we passed the Prescription Drug
Marketing Act more than decade ago, because I believe that my
views were made rather clear during last year's misguided
attempt to lower drug prices by opening up the borders of the
United States.
It is sufficient to say, however, that PDMA was
specifically designed to prevent the kinds of activities we are
reading about today, and discovering through the investigative
efforts of this subcommittee.
Our systems for protecting the U.S. consumers from drugs of
poor or dangerous quality are eroding, as recent evidence bears
out: First, last week, it was discovered that not one, but
three counterfeit drugs--Amgen-Serono, and Genentech--being the
victimized innovator companies, have been found on the shelves
of U.S. pharmacies.
It is unclear how much more exists, nor is it even clear
where counterfeit drugs may next surface. Second, drugs shipped
into this country by mail are overwhelming existing safeguards.
A recent pilot project conducted by the U.S. Customs
Service and the Food and Drug Administration stopped 16,000
parcels as you mentioned in approximately 1 month that were
being illegally shipped into the United States from foreign
sources.
Because the regulatory system at the Nation's mail
facilities is so overwhelmed and antiquated, 14,000 of these
parcels were simply sent to the public without any regulatory
review whatsoever.
And each day this scene is played out all over the country
as hundreds, if not thousands, of products enter this country
from abroad, and are sent to consumers without any safety check
whatsoever.
In testimony that will be given today, the FDA now admits
that approximately 2 million parcels containing FDA regulated
products are entering the United States each year through
international mail facilities, and most of these appear to have
received no review by FDA, and are simply released by Customs.
This is not a new problem, and the FDA has been put on
notice about it for years. Countless letters have been sent by
this subcommittee, by the Customs, to FDA warning about the
disintegration of the system and the hazards to the American
public that stem therefrom.
Customs now freely admits that while the present system
envisions that its staff hold all pharmaceuticals for FDA
review when they enter the country, in reality most are
delivered to consumers without knowing whether the drugs are
safe, or without any testing whatsoever, to protect American
consumers.
The FDA has so far demonstrated virtually no leadership on
how to fix a failed system that springs in large measure from
its own reimportation policies, and which we will examine
today.
We have never expected miracles nor instant success, but
after countless meetings, letters, discussions held by this
subcommittee and Customs imploring the FDA to retool a system
that places the public at severe risk, the FDA continues its
foot dragging.
Third, prescription drugs are flooding into the country
across the Mexican border. As you know, hundreds of Mexican
pharmacies now dot the border from Texas to California on the
Mexican side.
These pharmacists sell almost any type of drug to any
person wishing to buy them. As in the words of one of our
witnesses, ``like some stores sell candy.''
Buttressed by the FDA's vague and often misused and
misunderstood personal use policy, thousands of U.S. residents
cross the border each day to purchase their drugs from Mexico.
This practice raises many public health and safety issues as we
will hear from witnesses today.
How safe are these drugs and where do they come from? How
were they manufactured and how have they been stored, and are
the drugs counterfeit? Do they contain ingredients that will
harm a consumer? Have good manufacturing practices--required by
U.S. law--been practiced with regard to these pharmaceuticals?
Today, the testimony will suggest that the quality of
Mexican drugs are often difficult, if not impossible, to
determine. Some are perfectly safe, and some are counterfeit,
and some contain no active ingredient, and others contain too
much or too little active ingredient, posing similar risks.
Some, while clearly intended to be used under the close
supervision of a doctor, are prescribed with little or no
guidance, and most are prescribed without any significant
follow-up supervision.
Despite having policies that encourage this activity, our
government has almost no meaningful data from Customs, the Drug
Enforcement Administration, or the FDA, to address these issues
and questions.
And the budgets of the three agencies to carry out their
responsibilities on these matters is grossly inadequate, as are
the number of their personnel. Fourth, a questionable U.S.
policy allows U.S. residents to legally bring in large amounts
of potentially addictive and dangerous scheduled drugs without
a prescription.
This policy is open to significant abuse, and I believe
that we will find significant abuse is taking place. Last year
in a letter that I sent to the FDA concerning this matter, I
raised a number of questions relating to this problem by citing
the rather sobering findings of Dr. Marvin Shepherd.
I note that he is here today, and I hope that he will
receive the commendations of the committee. I thank him in
advance for his testimony, as well as the excellent work that
he has done on these matters over the years.
I also look forward to hearing from other witnesses,
including the DEA and the White House, as to whether they
believe that the potential good of the current policies
outweigh the enormous opportunity and potential for abuse
inherent in this policy.
Mr. Chairman, we indeed have several major policy problems
coming together here today. Our citizens are looking to other
countries to lower the cost of prescription drugs. They are
increasingly taking desperate measures to obtain them.
They are traveling to Mexico, and they are buying drugs
from Thailand, from China, from India, and everywhere else
through the Internet. The Federal Government must act and soon
to protect the safety of prescription drugs supplied, and
American consumers.
The Federal Government, however, must do more. Some
citizens are seeking alternative sources for drugs because they
believe that they have no choice. The high costs of
prescription drugs is driving them to take both legal and
health risks.
We must face that reality and seek to address the problem
of cost, whether it is through meaningful Medicare prescription
drug benefits intended through the use of expanded generic
drugs, the exercise of governmental purchasing power, or
otherwise, and action is needed and soon.
I hope that this hearing and continued subcommittee work
can lead to the long and short term steps needed to resolve
these problems, and again I commend you and thank you, Mr.
Chairman.
[The prepared statement of Hon. John D. Dingell follows:]
Prepared Statement of Hon. John D. Dingell, a Representative in
Congress from the State of Michigan
Mr. Chairman, thank you for holding this hearing. I am somewhat
saddened that we are yet again having to go over lessons that should be
all too familiar to this Subcommittee by now.
I will not elaborate on why we passed the Prescription Drug
Marketing Act (PDMA) more than a decade ago because I believe I made my
views rather clear during last year's misguided effort to attempt to
lower drug prices by opening up our borders. Suffice it to say,
however, that the PDMA was specifically designed to prevent the kinds
of activities we are reading about today and discovering through the
investigative efforts of this Subcommittee. Our systems for protecting
U.S. consumers from drugs of poor or dangerous quality are eroding, as
recent evidence bears out.
First, last week, it was discovered that not one, but three
counterfeit drugs--Amgen, Serono, and Genentech being the victimized
innovator companies--have been found on the shelves of U.S. pharmacies.
It is unclear how much more exists, nor is it even clear where
counterfeit drugs may surface next.
Second, drugs shipped into the country by mail are overwhelming
existing safeguards. A recent pilot project conducted by the U.S.
Customs Service (Customs) and the Food and Drug Administration (FDA)
stopped 16,000 parcels in approximately one month that were being
illegally shipped into the United States from foreign sources. Because
the regulatory system at the nation's mail facilities is so overwhelmed
and antiquated, 14,000 of these parcels were simply sent to the public
without any regulatory review. And each day, this scene is played out
all over the country as hundreds, if not thousands, of products enter
this country from abroad, and are sent to consumers without any safety
check. In testimony that will be given today, FDA now admits that
approximately two million parcels containing FDA-regulated products are
entering the U.S. each year through the international mail facilities,
and most of these appear to receive no review by the FDA, and are
simply released by Customs.
This is not a new problem, and FDA has been put on notice about it
for years. Countless letters have been sent by this Subcommittee, and
by Customs, to FDA warning about the disintegration of this system.
Customs now freely admits that while the present system envisions that
its staff hold all pharmaceuticals for FDA review when they enter the
country, in reality, most are delivered to consumers without knowing
whether these drugs are safe.
FDA has so far demonstrated little leadership on how to fix a
failed system that springs in large measure from its own reimportation
policies. We have never expected miracles or instant success. But after
countless meetings, letters, and discussions held by this Subcommittee
and Customs imploring FDA to retool a system that places the public at
risk, the FDA continues its foot-dragging.
Third, prescription drugs are flooding into the country across the
Mexican border. As you know, hundreds of Mexican pharmacies now dot the
border from Texas to California. These pharmacies sell almost any type
of drug to any person wishing to buy them--as in the words of one of
our witnesses, ``like some stores sell candy.''
Buttressed by FDA's vague and often misused personal-use policy,
thousands of U.S. residents cross the border each day to purchase their
drugs from Mexico. But this practice raises many public health and
safety issues, as we will hear from the witnesses today. How safe are
these drugs and where do they come from? How are they manufactured, and
how are they stored? Are these drugs counterfeit? Do they contain
ingredients that can harm a consumer?
Testimony today suggests that the quality of Mexican drugs is often
difficult, if not impossible, to determine. Some are perfectly safe.
Some are counterfeit and contain no active ingredient. Others can
contain too much or too little active ingredient, posing similar risks.
Some, while clearly intended to be used under the close supervision of
a doctor, are prescribed with little or no guidance, and most are
prescribed with little or any followup supervision.
Despite having policies that clearly encourage this activity, our
government has almost no meaningful data from Customs, the Drug
Enforcement Administration (DEA), or the FDA to address any of these
issues and questions.
Fourth, a questionable U.S. policy allows U.S. residents to legally
bring in potentially large amounts of potentially addictive and
dangerous scheduled drugs without a prescription. This policy is open
to significant abuse. Last year, in a letter I sent to the FDA
concerning this matter, I raised a number of questions relating to this
problem by citing the rather sobering findings of Dr. Marvin Shepherd.
I see that he is before us today, and I thank him in advance for his
testimony as well as the excellent work he has done on this matter over
these years. I also look forward to hearing from our other witnesses,
including the DEA and the White House, on whether they believe the
potential good outweighs the potential abuse inherent in this policy.
Mr. Chairman, indeed, we have several major policy problems coming
together here. Our citizens are looking to other countries for lower
cost prescription drugs, and are increasingly taking more desperate
measures to obtain them. They are traveling to Mexico. They are buying
drugs from Thailand, China, India, and everywhere else, through the
Internet. The Federal Government must act, and soon, to protect the
safety of the prescription drugs supply.
But the Federal Government must do more. Some citizens are seeking
alternative sources for drugs because they believe that they have no
choice. The high cost of many prescription drugs is driving them to
take both legal and health risks. We must face that reality and seek to
address the problem of cost. Whether that is through a meaningful
Medicare prescription drug benefit, expanded use of generic drugs,
exercise of governmental purchasing power, or otherwise, we must act,
and soon.
I hope this hearing, and continued Subcommittee work, can lead to
both the short-term and long-term steps needed to solve these problems.
Mr. Greenwood. The Chair thanks the ranking member of the
full committee, and recognizes now the chairman of the
Subcommittee on Health, Mr. Bilirakis, from Florida.
Mr. Bilirakis. Thank you very much, Mr. Chairman. I, too,
am grateful that you are holding this hearing, and of your
interest in this particular subject. Access to affordable
prescription drugs, particularly for our seniors, is a very
serious concern.
Many Members of Congress, myself included, and particularly
myself because of the district that I represent in Florida,
have heard from constituents who are upset about paying more
for prescription drugs than citizens of other countries.
And some of these Americans travel outside the United
States to purchase their pharmaceuticals. The Food and Drug
Administration currently allows under certain circumstances and
bounds for patients to bring in a 3 month supply of
prescription drugs for their personal use.
Today, drugs are often purchased by an individual through
the mail or the Internet. However, the policy allowing the
importation for these uses was not intended, I think, to
promote these practices on such a broad, broad basis.
As I understand it, the consensus view within the FDA and
the Customs Service is generally not to interfere with seniors
who decide to assume the health risks of buying drugs for
personal use.
Furthermore, the FDA and Customs are overwhelmed by the
amount of drugs coming in over our borders and through the
mail, and I know, Mr. Chairman, that I have heard you talk
about your visit out to Dulles and seeing the amount of drugs
coming in and how it has overwhelmed Customs out there.
Over the last decade, there has also been an increase in
the shipments of bulk or active pharmaceutical ingredients from
overseas. Any foreign firm that makes bulk ingredients for the
U.S. market must be inspected by the FDA.
Therefore, it is important to understand the impact of
these developments on the agency's limited resources. I am
hopeful that today's hearing will shed light on these and other
important issues related to the safety of imported
pharmaceuticals.
Mr. Chairman, I have to go and do an organ transplant type
of a thing in a few minutes, and so I will break loose, but I
would like to come back, because this is of great interest.
Thank you very much, sir.
[The prepared statement of Hon. Michael Bilirakis follows:]
Prepared Statement of Hon. Michael Bilirakis, a Representative in
Congress from the State of Florida
Thank you Chairman Greenwood for holding today's hearing on the
safety of imported pharmaceuticals. I look forward to hearing from our
witnesses and learning more about this important issue.
Access to affordable prescription drugs, particularly for our
seniors, is a serious concern. Many Members of Congress--myself
included--have heard from constituents who are upset about paying more
for prescription drugs than citizens of other countries. Some of these
Americans now travel outside the United States to purchase their
pharmaceuticals.
The Food and Drug Administration (FDA) currently allows patients to
bring in a three-month supply of prescription drugs for their personal
use. Today, drugs are often purchased by an individual through the mail
or the Internet. However, the policy allowing importation for personal
use was not intended to promote these practices on such a broad basis.
As I understand it, the consensus view within the FDA and the
Customs Service is generally not to interfere with seniors who decide
to assume the health risks of buying drugs for personal use.
Furthermore, FDA and Customs are overwhelmed by the amount of drugs
coming in over our borders and through the mail.
Over the last decade, there has also been an increase in the
shipments of bulk or ``active pharmaceutical ingredients'' from
overseas. Any foreign firm that makes bulk ingredients for the U.S.
market must be inspected by the FDA. Therefore, it is important to
understand the impact of these developments on the agency's limited
resources. I am hopeful that today's hearing will shed light on these
and other important issues related to the safety of imported
pharmaceuticals.
Mr. Greenwood. Hopefully that is testimony and not surgery.
The Chair thanks the subcommittee chairman and recognizes the
ranking member of the Oversight and Investigations
Subcommittee, the gentleman from Florida, Mr. Deutsch.
Mr. Deutsch. Thank you, Mr. Chairman, and thank you for
holding this hearing. Mr. Chairman, this committee has always
had a great interest in the safety of the U.S. drug supply, and
has always had a rich tradition of monitoring any threats to
that system.
Lately, however, there are a number of issues with which we
must concern ourselves. Several years ago, this subcommittee
began an investigation into how prescription drugs were being
sold both domestically and internationally through the
Internet.
When this subcommittee first began its inquiry only a
handful of firms existed, and only a trickle of drugs were
entering the U.S. as a result of these activities. It was
predicted then that if this problem was not quickly addressed
by the FDA and other key agencies that the existing systems
used to process incoming parcels of mail would quickly be
outpaced by the volume of foreign shipments.
This prediction has become a reality, Mr. Chairman. But
once merely an annoyance to the regulatory system, the volume
of unregulated drugs now entering the U.S. through the Nation's
13 international mail facilities threatens to undermine the
original intent of the Prescription Drug Marketing Act,
legislation passed by the Committee on Energy and Commerce for
the purpose of protecting our citizens from adulterated or
substandard drugs from abroad.
Currently, tens of thousands of unregulated parcels
containing a variety of drug products enter the U.S. each week.
U.S. Customs inspectors can't keep pace with the workload, nor
do they have meaningful guidance or sufficient help from the
FDA to properly process them.
Instead, the U.S. Customs is overwhelmed. They are often
forced to release the shipments to the public without any FDA
scrutiny. It now appears more the exception that the FDA
examines the bulk of these incoming parcels.
The situation at many of these ports of entry has thus
become a ticking public health time bomb. Indeed, the amount of
wholly unregulated drug parcels coming into this country
through our mail facilities is not trivial.
Just a few weeks ago, Mr. Stupak, Chairman Greenwood, and
I, visited the Dulles Airport facility. What we found was
sobering. Before our arrival, the U.S. Customs inspectors
detained 167 parcels containing drugs in just 4 hours.
Most of what we saw was a haphazard collection of unmarked
and misbranded drugs. Many contained no labels, while many
drugs were mixed with other drugs. Some parcels had false
declarations, while most contained no prescription nor any
indication that a drug was being taken under supervision of a
doctor or a pharmacist.
In recent pilot projects at the Los Angeles mail facility,
Customs detained an astonishing 16,000 shipments in just over a
1-month period. But because the system used today is so archaic
and understaffed, the FDA had time to examine only about 1,900
of these parcels.
What happened to the other 14,000 parcels? The same thing
that happens every day across this country. They were released
to the public without any FDA review. Were they safe? Who
knows. Were they real? Who knows.
Were they properly stored? Who knows? But what is known is
that this practice is the pharmaceutical version of Russian
Roulette, placing the public at risk. Nevertheless, despite
mounting evidence for the past several years that this system
is spiraling out of control, and after receiving numerous
letters from the U.S. Customs Service and this subcommittee to
examine this system to put forth rational proposals on how to
address this problem. The FDA, which is responsible for the
system, has failed to act. Instead, by taking a head in the
sand approach and ignoring years of warning signs, the agency
inaction has only contributed to the chaos.
I look forward to this hearing and hearing from FDA, who is
finally making proposals, specific proposals, to retool a very
broken system.
Mr. Chairman, let me quickly shift gears here to mention
another issue that we will be discussing today, which is the
matter of drugs coming in from Mexico. Currently, tens of
thousands of U.S. citizens are making monthly trips to Mexico
to buy a group of drugs from the hundreds of pharmacies that
exist within easy walking distance of the border.
Currently, a number of policies now exist that allow and
may even encourage U.S. citizens to shop for their drugs in
Mexico. Aside from the fact that our regulatory agencies seem
to know almost nothing about the quality or sources, many of
our witnesses will voice concerns about some of these
practices.
For example, current policy allows for a U.S. citizen to
walk across the border and bring back a vast array of powerful
and potentially addictive controlled substances as long as they
are declared to U.S. Customs upon reentering the U.S.
This means that while U.S. citizens must have a
prescription from a doctor to obtain a potentially dangerous
substance in San Diego, if they walk across the border to
Tijuana, they can buy an almost endless supply of Schedule II
to V drugs as long as each drug does not exceed 50 tablets.
Why is that, Mr. Chairman? As many controlled substances
also have inexpensive generic versions available here in the
U.S., serious questions must be raised about the objective of
such a policy.
And as Dr. Shepherd, who will testify here later, points
out, evidence suggests that many of these drugs are being
purchased by younger persons for recreational use or resale on
the street.
But whatever our decisions are to be in this regard, at a
very minimum, we need better information. If we intend to allow
persons to obtain drugs from Mexico, we should better assess
what risks are involved in this practice to at least allow U.S.
citizens to make informed choices.
Currently, despite the fact that tens of thousands of U.S.
Citizens purchase their drugs from Mexico every month, there is
little data to tell us what the public health implications of
such practices are.
If we are going to have policies that permit and even
encourage such behavior, we must better assess all the risks
involved. Let me conclude, Mr. Chairman, by also saying that we
must also attempt to analyze why is it that many U.S. citizens
are purchasing their medications through these poorly regulated
channels.
This is not an easy task, but it is an essential ingredient
in attempting to address some of the public safety issues
raised by the activities that we will discuss today. Clearly,
while some might be seeking drugs for their abuse potential,
others clearly travel to Mexico or purchase their drugs through
the Internet because they feel such practices save them money.
In some cases involving certain countries, this may be a
dangerous practice. Providing better and affordable
alternatives to these practices is an essential stepping stone
toward effective solutions to some of these problems.
I believe that if we wish to be successful in addressing
the massive amounts of drugs entering the U.S. through
unregulated channels, we need to come to an agreement on how to
make prescription drugs more affordable for all U.S. citizens
that need them, and I welcome this debate.
Thank you, Mr. Chairman, and I look forward to hearing from
the witnesses today.
[The prepared statement of Hon. Peter Deutsch follows:]
Prepared Statement of Hon. Peter Deutsch, a Representative in Congress
from the State of Florida
Thank you Mr. Chairman, and thank you for holding this hearing.
Mr. Chairman, this Committee has always had a great interest in the
safety of the U.S. drug supply and it has always had a rich tradition
of monitoring any threats to that system. Lately, however, there are a
number of issues with which we must concern ourselves.
Several years ago, this Subcommittee began an investigation into
how prescription drugs were being sold both domestically and
internationally through the Internet. When this Subcommittee first
began its inquiry, only a handful of firms existed and only a trickle
of drugs were entering the U.S. as a result of these activities.
It was predicted then that if this problem was not quickly
addressed by the FDA and other key agencies, existing systems used to
process incoming parcels of mail would quickly be out-paced by the
volume of foreign shipments. That prediction has become a reality, Mr.
Chairman.
While once merely an annoyance to the regulatory system, the volume
of unregulated drugs now entering the U.S. through the nation's 13
international mail facilities threatens to undermine the original
intent of the Prescription Drug Marketing Act, legislation passed by
the Committee on Energy and Commerce for the purpose of protecting our
citizens from adulterated or substandard drugs from abroad.
Currently, tens of thousands of unregulated parcels containing a
variety of drug products enter the U.S. each week. U.S. Customs
inspectors can't keep pace with the workload, nor do they have
meaningful guidance or sufficient help from FDA to properly process
them.
Instead, U.S. Customs is overwhelmed. They are often forced to
release the shipments to the public without any FDA scrutiny. It now
appears more the exception that FDA examines the bulk of these incoming
parcels. The situation at many of these ports of entry has thus become
a ticking public-health time bomb.
Indeed, the amount of wholly unregulated drug parcels coming into
this country through our mail facilities is not trivial. Just a few
weeks ago, Mr. Stupak, Chairman Greenwood, and I visited the Dulles
airport facility.
What we found was sobering. Before our arrival, U.S. Customs
inspectors detained 167 parcels containing drugs in just four hours.
Most of what we saw was a haphazard collection of unmarked and
misbranded drugs. Many contained no labels, while many drugs were mixed
with other drugs. Some parcels had false declarations, while most
contained no prescription nor any indication that the drug was being
taken under the supervision of a doctor or a pharmacist.
In a recent pilot project at the Los Angeles mail facility, Customs
detained an astonishing 16,000 shipments in just over a one-month
period. But because the system used today is so archaic and
understaffed, FDA had time to examine only about 1,900 of these
parcels.
What happened to the other 14,000 parcels? The same thing that
happens every day across this country--they were released to the public
without any FDA review. Were they safe? Who knows. Were they real? Who
knows. Were they properly stored? Who knows. But what is known is that
this practice is the pharmaceutical version of Russian roulette,
placing the public at risk.
Nevertheless, despite mounting evidence for the past several years
that this system is spiraling out of control, and after receiving
numerous letters from the U.S. Customs Service and this Subcommittee to
examine this system to put forth rational proposals on how to address
this problem, the FDA--which is responsible for this system--has failed
to act. Instead, by taking a ``head-in-the-sand'' approach and ignoring
years of warning signs, the agency's inaction has only contributed to
the chaos. I look forward to hearing whether the FDA finally has any
meaningful proposals on how to retool a very broken system.
Mr. Chairman, let me quickly shift gears here to mention another
issue that we will be discussing today, which is the matter of drugs
coming from Mexico.
Currently tens of thousands of U.S. citizens make monthly trips to
Mexico to buy a myriad of drugs from the hundreds of pharmacies that
exist within easy walking distance of the border. Currently, a number
of policies now exist that allow--and may even encourage--U.S. citizens
to shop for their drugs in Mexico. Aside from the fact that our
regulatory agencies seem to know almost nothing about the quality or
sources, many of our witnesses will voice concerns about some of these
practices.
For example, current policy allows for a U.S. citizen to walk
across the border and bring back a vast array of powerful and
potentially addictive controlled substances, as long as they are
declared to U.S. Customs upon reentering the U.S. This means that while
a U.S. citizen must have a prescription from a doctor to obtain a
potentially dangerous substance in San Diego, if they walk across the
border to Tijuana they can buy almost an endless supply of schedule II-
V drugs, as long as each drug does not exceed 50 tablets. Why is that,
Mr. Chairman?
As many controlled substances also have inexpensive generic
versions available here in the U.S., serious questions must be raised
about the objective of such a policy. And as Dr. Shepherd, who will
testify later today, points out, evidence suggests that many of these
drugs are being purchased by younger persons for recreational use or
resale on the street.
But whatever our decisions are to be in this regard, at a very
minimum we need better information. If we intend to allow persons to
obtain drugs from Mexico we should better assess what risks are
involved in this practice to at least allow U.S. citizens to make
informed choices. Currently, despite the fact that tens of thousands of
U.S. citizens purchase their drugs from Mexico every month, there is
little data to tell us what the public health implications of such
practices are. If we are going to have policies that permit and even
encourage such behavior, we must better assess all risks involved.
Let me conclude, Mr. Chairman, by also saying that we must also
attempt to analyze why it is that many U.S. citizens are purchasing
their medications through these poorly regulated channels. This is not
an easy task, but it is an essential ingredient in attempting to
address some of the public safety issues raised by the activities we
will discuss today. Clearly, while some might be seeking drugs for
their abuse potential, others clearly travel to Mexico or purchase
their drugs through the Internet because they feel such practices save
them money. In some cases involving certain countries, this may be a
dangerous practice. But providing better and affordable alternatives to
these practices is an essential stepping stone toward effective
solutions to some of these problems.
I believe that if we wish to be successful in addressing the
massive amount of drugs entering the U.S. through unregulated channels,
we need to come to agreement on how to make prescription drugs more
affordable for all U.S. citizens that need them, and I welcome that
debate.
Thank you, Mr. Chairman, and I look forward to hearing from our
witnesses today.
Mr. Greenwood. The Chair thanks the gentleman, and
recognizes for 5 minutes the gentleman from Michigan, Mr.
Stupak.
Mr. Stupak. Thank you, Mr. Chairman, and thank you for
holding this very important hearing on imported
pharmaceuticals, and thanks for your work on this issue.
Mr. Chairman, we are facing a problem of immense
proportions and are simply unprepared to deal with it.
Unregulated and unsupervised drugs are pouring into this
country, and with the advent of Internet pharmacies, the volume
of pharmaceutical products being shipped into the United States
has exploded.
Unfortunately, the resources that we have put together to
deal with this problem has not met the needs, and the hearing
that we are holding today is the first of hopefully more
hearings that we will have on this all too familiar topic for
me.
In the last Congress, I, myself, Mr. Dingell, Mr. Klink,
Mr. Waxman, and others, actually tried to introduce a bill, and
did introduce a bill to specifically deal with the sale of
prescription drugs through the Internet.
And I intend to reintroduce a very similar bill again
shortly. This bill will help, but will not stop, the flow of
unregulated drugs into this country. We simply cannot allow
this situation to continue unchecked, and we need to work with
all the authorities to make sure that when we do pass a bill
that we get it right.
Mr. Chairman, you, I, and the ranking member, Mr. Deutsch,
saw the problem of mail order prescription drugs first-hand
several weeks ago on our trip down to the Dulles Airport mail
facility.
Hundreds of packages of illegal drugs pulled from a mere 3
days worth of international mail lay on the tables in the
Customs area for our inspection, and I suppose that some of
those packages there are what we saw at Dulles.
The packages were breathtaking in their variety; pink
pills, red pills, green pills, white pills, yellow liquid,
brown liquid, clear liquid, capsules, tablets, powder, paste,
blister packs, zipped lock baggies. You name it, it was there.
We saw pills stuffed in bras, pills stuffed in cotton,
pills stuffed in carbon paper, because the smugglers think that
the x-ray will be fooled with the carbon wrapped around their
pills. And pills wrapped in birthday presents. All of these
were headed to the American public.
American citizens have no idea if the pharmacy that they
receive their pills from is an FDA-approved facility, or a
vermin-filled kitchen table in a flophouse, run by an
individual in Thailand with hepatitis, working with a
prostitute as his assistant.
But I am sure that they have a very nice video web page or
website to get us all to buy their drugs. And these are just
the pills that the individuals order. It does not take into
account or begin to address the problem of bulk and counterfeit
drug ingredients and products, more and more which are showing
up in today's health care market.
Mr. Chairman, a lot of us reviewed the report of the L.A.
Airport, in which we looked at and found what was coming into
L.A. in just 4 to 5 weeks. We have a list here today, and there
were over 16,000 parcels that came in within that 4 to 5 weeks.
And in that 4 to 5 weeks, like in one parcel, three bottles
of unknown medication, approximately 300 tablets. The tablets
are green and the bottles are labeled in a foreign language. No
English.
Or another one, 1,080 dosage units; 1,080 tablets of an
unknown tablet, dark brown in color. That is what we are seeing
coming through the mail. And today it is estimated that over 2
million parcels a year comes into this country unknown,
unmarked, and where they are going, and what they contain. The
American consumer has no idea.
And this number is only going to continue to grow unless we
do something about it. What we need to do in today's hearing is
not to simply figure out who is responsible for these illegal
drugs coming into our country, but take some action, and take
some action now.
The FDA has been asked time and time again for direction.
Letter after letter has been sent to the FDA, not only from
Customs, but also from this Congress and this subcommittee,
asking for guidance.
These letters and pleas have not yielded any substantive
answers, strategies, nor proposals. Because of the FDA's
failure to act, what started out to be a small problem is now
flooding this country.
It is time for the FDA to move off-center. We also have the
50 fill problem, 50 pills without prescription, at the Mexican
border; and Mr. Dingell, and Mr. Deutsch, and others have spoke
up today, and that needs to be addressed, and once again, we
need to address it now.
We have in front of our committee today all the interested
parties, and I hope that we can come up with a defined
consensus on what should be done on each of these issues.
I look forward to continuing to work with you, Mr.
Chairman, and others on this committee, on this very, very
important and deadly matter. Thank you.
Mr. Greenwood. The Chair thanks the gentleman from
Michigan, and recognizes for an opening statement for 5 minutes
the gentlelady from Colorado, Ms. DeGette.
Ms. DeGette. Thank you, Mr. Chairman, and thank you for
holding this hearing today. This is at least the third hearing
in a row that we have had annually regarding the importation of
pharmaceuticals.
I hope this hear that we can actually make some progress so
that we don't find ourselves again next year about the same
time in this same room, in the same chairs rehashing the
information, when frankly our constituents' lives continue to
be at risk.
I am hopeful that it won't take another t.v. expose, a
newspaper series, some reporter ordering viagra for their dog,
or worse, and seriously, an incident of patient deaths, and for
meaningful action to be undertaken immediately.
As I said last year in my opening statement about this same
time, on-line access to pharmaceuticals can be a wonderful took
and one that has opened up a whole new world of convenience to
patients.
One thing that hasn't been focused on today is the ease
with which chronic patients can get information and can easily
get their prescription drugs on-line at a decent price.
That can be a benefit to patients.
I am the Co-Chair of the Congressional Diabetes Caucus, and
for those with chronic long term illnesses, it can be an
enormous convenience to use the Internet. But with this ease
comes risks. One of the biggest risks as we have heard is the
explosion in the counterfeit prescription drug market and its
potential to do great harm to individuals.
Mr. Chairman, I know how this can affect a community,
because it happened right in my district in Denver, Colorado.
In 1998, six patients at a Denver hospital had toxic reactions
to counterfeit pharmaceuticals.
According to Dr. Michael Earnest, who is a physician at the
Denver Health Medical Center, failure of the FDA to adequately
inform the hospital of the potential for counterfeit
pharmaceuticals contributed to this frightening occurrence.
Health officials in other States according to U.S. News and
World Report, have echoed this concern. This problem is
beginning to be a real threat to the health of the American
people when you can't even count on avoiding counterfeit
pharmaceuticals in a hospital.
If the United States does not begin to seriously address
this problem and step up oversight activities, there will be
more counterfeit drugs in the United States and more Americans
put in harm's way.
Improper oversight has permitted individuals to remove both
the doctor's role of prescribing drugs and equally important
the pharmacist's role in providing the patient another source
of medical advice.
We need to have standard policies regarding pharmaceutical
purchases. It doesn't make sense to require a prescription for
drugs purchased in the United States, but then to look the
other way when someone walks back into the States with
regulated substances, or purchases them on the Internet without
a prescription.
We simply cannot any longer allow the elimination of
important safeguards. Purchasing pharmaceuticals without the
help of real doctors, or without the advance of real
pharmacists, is extremely dangerous.
Mr. Chairman, these issues are a product of a larger living
problem for our Nation; the explosion in the cost of health
care, including pharmaceutical drugs. And Mr. Stupak talked
about this for a moment.
One of the reasons that folks are turning toward these
Internet pharmaceuticals or the border is because they are
trying to obtain needed medications as a way to stretch or fix
on limited budgets.
We cannot, however, lose sight of that larger story. We owe
it to our constituents to provide protections wherever the
pharmaceuticals are purchased. As Dr. Shepherd, who is
testifying today, suggests, many purchases are not made by the
Nation's poor and elderly to save costs.
Individuals who do not intend to personally use them
purchase a significant amount of these drugs, and this is
further substantiated by the DEA's testimony which we will hear
today, which is stating that a healthy stream of people is
going across the border to purchase controlled substances.
Enforcement of the current laws is going to be critically
important in this effort. According to an FDA pilot program
that ran for 30 days earlier this year, potentially 16,000
parcels could have been referred by Customs to the FDA.
Clearly, there is a torrential flood of prescription drugs
entering the U.S. I think it is safe to assume that a large
percent of them are illegal and potentially lethal. If
controlling this flow is a matter of resources, Mr. Chairman,
we need to know what the magnitude of the problem is, and we
need to allocate the resources for enforcement of current laws.
I think it is important that we discuss today the current
law, and whether that is being adequately enforced, and whether
we need changes to the law or more resources; what is the
extent of the problem, and what do we need to do to resolve the
situation.
Mr. Chairman, I look forward to hearing the witnesses'
testimony, and their responses to questions posed by members,
and I yield back the balance of my time.
Mr. Greenwood. The Chair recognizes the arrival of Mr.
Whitfield and Mr. Gillmor. Do either of those gentlemen have
opening statements to make?
Mr. Gillmor. I waive my opening statement.
Mr. Whitfield. I waive.
Mr. Greenwood. The gentlemen both waive their option of
making an opening statement.
[Additional statements submitted for the record follow:]
Prepared Statement of Hon. Cliff Stearns, a Representative in Congress
from the State of Florida
Thank you Chairman Greenwood for holding this important hearing. I
also want to thank our witnesses for being here today and I look
forward to hearing their testimony.
Today we will hear about several very troubling aspects related to
imported pharmaceuticals. A chief concern is that many individuals are
purchasing pharmaceuticals along the Mexican borders. What many of
these consumers may not know is that they may not necessarily be
getting what they think they are purchasing. Without strict standards
such as those required in the United States, these drugs could be
nothing more than placebos, or could contain ingredients that could
pose a health risk. In particular, seniors seek these cheaper
prescription drugs. While they do so at their own risk and this is not
against the law, it is nevertheless puts them at risk. Hearings such as
this will provide individuals who cross the border to buy their drugs
with valuable information about the potential dangers involved.
More and more individuals are going on-line to order prescriptions
through the mail from foreign countries. How can consumers know whether
these products are genuine? Another question that individuals who
purchase their prescription from overseas need to consider is how safe
is to go on-line and divulge personal information about themselves.
There is no way to verify whether the companies selling these products
are legitimate. Let the buyer beware is very apt when such buying
practices are being conducted.
I wonder if it would be beneficial to have more regulation of these
drugs that are flowing into our country through the mail.
Counterfeiting of bulk drugs has become one of the most lucrative and
also one of the most potentially dangerous issues associated with
imported drugs.
These look a like drugs are produced all over the globe and make
their way to this country in vast quantities. I have seen these drugs
and they appear to be authentic because they look identical to drugs
produced by pharmaceuticals made in this country. The packaging looks
identical and sadly enough can have detrimental effects because the
patients will not be getting the medications they need to treat their
illness.
I hope today's hearing will provide us with some answers and
perhaps some reassurance that we can stop these dangerous products from
entering our country.
______
Prepared Statement of Hon. W.J. ``Billy'' Tauzin, Chairman, Committee
on Energy and Commerce
Chinese cough medicine filled with poisonous anti-freeze kills 89
children in Haiti.
Counterfeit imported anti-seizure drugs suspected of killing
several epileptics in the U.S.
Thousands of drugs sold to Americans through the mail from foreign
internet pharmacies made in filthy, vermin-infested labs.
Powerful, deadly painkillers declared and brought from Mexico or
Canada into the U.S.
People who die or are injured by self-medicating with prescription
drugs of unknown quality, unknown dosage levels, unknown impurities,
unknown side effects, and unknown interactions.
These are examples of the dangers of many imported pharmaceuticals.
Drum-by-drum, parcel-by-parcel, consumer-by-consumer, imported
pharmaceuticals are arriving from unapproved sources, border
pharmacies, and even bathtubs or dirty kitchens. Many of these products
threaten the public health.
The problem of counterfeit drugs is not just a phenomenon of the
developing world. Our lucrative market and ineffective import controls
are increasingly making the United States an attractive target for drug
counterfeiters and diverters. Last month, three counterfeit
prescription drugs were found in the shelves of pharmacies of several
states. It is not known whether these fake drugs were made in the
United States or overseas. But such a cluster of counterfeits has not
been seen for years in this country.
This public health threat of imported pharmaceuticals is getting
worse virtually by the day. More Mexican border pharmacies. More
foreign internet pharmacies. More drugs in the international mail. More
pharmaceutical ingredients from overseas. More people in desperate
straits who seek cheaper medicines from abroad. More hucksters,
criminals, snake-oil salesmen, slick-willies, and con artists who prey
upon consumers, distributors, and manufacturers.
Meanwhile, our federal agencies responsible for keeping out
dangerous drugs are no longer maintaining the pretense that the problem
can be controlled. For example, in its December 2000 Performance Plan
Summary, the Food and Drug Administration stated: ``The Agency is
unable to assure the U.S. public that it can prevent unsafe imports
from entering the country.'' The data from a recent joint project
between the FDA and the U.S. Customs Service show only a small fraction
of drugs in the mail ever gets examined by the FDA and even a visual
examination of these products cannot detect the full extent of
counterfeit or substandard product. On one side, the FDA and the
Customs Service are overwhelmed by a flood of commercial shipments of
imported bulk ingredients. On the other, these agencies are confronted
by thousands of individuals with personal imports, an army of ants
overrunning the system.
Unless we find new effective solutions soon, I believe it is only a
matter of time that these uncontrolled imported drugs will lead to an
epidemic here that will kill, maim or severely sicken people.
Fortunately, this hearing is an important start in reaching solutions.
In so doing, we won't lose sight of the real-life problems seniors and
other Americans are facing with high drug prices. I know many Americans
are resorting to getting what they believe--or have been told to
believe--are cheaper versions of U.S. drugs in Canada and Mexico. In
many cases, these foreign drugs are not cheaper and they are not the
same as U.S. drugs. But the problem of high drug prices and
prescription drug coverage is one that we will deal with directly in
this Committee. While we tackle affordability, we will pursue safety
solutions that target the greatest health risks, and at the same time,
minimize disruption and risks for those who feel they must avail
themselves of pharmaceuticals in Canada and Mexico.
I congratulate the Subcommittee Chair, Congressman Jim Greenwood,
for this essential hearing. He has invited an impressive array of
expert witnesses to assess the issues and to discuss proposals and
recommendations. I look forward to hearing the testimony, examining the
evidence, and getting some answers.
______
Prepared Statement of Hon. Bobby L. Rush, a Representative in Congress
from the State of Illinois
Mr. Chairman, thank you for holding this important hearing on the
importation of drugs. More than ever before, Americans rely on drugs to
treat chronic health conditions, protect themselves from disease and
improve the quality of their lives. Whether the illness be high blood
pressure, diabetes or cholesterol, pharmaceuticals allow many to enjoy
a better quality of life. Some of the safety concerns surrounding the
issue of imported drugs could potentially undermine this ability.
A New York Times article from April of this year reported that
American law enforcement officials have estimated the percentage of
counterfeit and substandard imported drugs could be as high as 25
percent of the imports. In the past two years, this Committee has
investigated the FDA's oversight of counterfeit foreign bulk drugs and
uncovered a severe failure by FDA to identify and pursue counterfeit
drug makers and distributors, despite internal FDA documents
highlighting the dangers posed by specific imported medicines.
We must continue to ensure that Americans have access to safe drugs
and I look forward to hearing from the witnesses as to what we can do.
Mr. Greenwood. For the benefit of the witnesses, the bells
that you just heard indicate that we have a vote on the floor.
And since we would all like to be here for your testimony,
the committee will recess for 15 minutes, and reconvene at 11
o'clock.
[Brief recess.]
Mr. Greenwood. The committee will reconvene. Without
objection, a statement from U.S. Representative Gil Gutknecht
will be entered into the record, and hearing no objection, it
is so ordered.
[The prepared statement of Hon. Gil Gutknecht follows:]
Prepared Statement of Hon. Gil Gutknecht, a Representative in Congress
from the State of Minnesota
Mr. Chairman, as a Member of Congress long concerned with our
Nation's policy regarding imported pharmaceuticals, and who authored
legislation regarding mail order imports signed into law just a few
months ago (PL 106-948, Sec. 746), I appreciate this opportunity to
offer my opinion about the direction our drug import policy should
take. I have a long-term vision for what our wholesale importation
policy should be, but today I want to address the narrower subject of
this hearing: government treatment of prescription drugs mail-ordered
from another country for personal use. My point is simple. The FDA's
personal use importation policy is currently fatally flawed, as it
favors the most dangerous, unapproved drugs, while disfavoring commonly
prescribed, FDA-approved drugs that can be safely imported for personal
use.
I learned about this issue several years ago, when some of my
constituents--who would soon be joined by thousands of Americans--
traveled to Canada on buses to buy commonly-prescribed, FDA-approved
drugs available at about half the price for which those same drugs are
sold in the United States. These constituents' faced no difficulty at
the border importing their Coumadin, Prilosec, and Lipitor--commonly
prescribed, FDA-approved drugs. However, when they tried to reorder
those same drugs through the mail, the FDA stopped the packages, opened
them, and enclosed warning letters saying the drugs appeared to be
illegal and might be confiscated if they were imported again.
Needless to say these constituents were confused by the FDA's
disparate treatment of the same product--easy admission on the bus at
the border, strict warnings in the mail. As it turns out, my
constituents had encountered what is only one of the many
inconsistencies and, indeed, flaws in the FDA's personal use
importation policy--a patchwork quilt of written and unwritten rules
that finds no basis in statute. Because I've explained these flaws in
detail in a letter to the Secretary of Health and Human Services, Tommy
Thompson, I will only briefly outline them here and request that my
letter to the Secretary be entered into the Record.
The first problem with the FDA's personal use policy today is that
it favors unapproved drugs over approved drugs. In the early 1990s, the
FDA evolved a ``compassionate use'' policy regarding importation of
prescription drugs. This policy allowed individuals seeking medical
treatments not available in this country to bring unapproved drugs into
the United States for their personal use. However, in the last few
years, this policy has evolved into the FDA's current, unwritten,
``personal use'' policy. Under this policy, the FDA allows individuals
to bring up to a three-month supply of drugs into the United States on
their person, whether the drugs are approved for use in the United
States or not. My constituents took advantage of this policy when they
brought lower-cost drugs back into the United States by bus.
Thus, the FDA's written policy expressly allows imports of
unapproved, experimental drugs, but disallows imports of FDA-approved
drugs. This doesn't make any sense. As I wrote to Secretary Thompson,
``While I certainly agree that the very sick should have formal access
to unapproved products, it makes no sense . . . that the very poor
should not have formal access to approved products.''
The second problem with the FDA's personal use policy is that it
favors drugs carried across the border to drugs mailed across the
border. As my constituents found out, the FDA currently allows drugs to
be carried across the border that it disallows when they appear at the
border in the mail. This, too, makes no sense. Why should the FDA allow
an individual to carry a drug into the United States on their person,
but stop that individual from refilling the very same prescription from
the same pharmacy through the mail? I have yet to hear a compelling
answer to this question.
But perhaps what is most interesting, and disturbing, about the
FDA's complex array of written and unwritten drug importation rules is
that none of them has a basis in statute. The FDA has used its
discretionary authority to create an ad hoc drug importation system
that favors the most dangerous products while stopping the safest. To
put it in Biblical terms, the FDA's policy strains out a gnat, but
swallows a camel. When I have raised this point with the FDA, the
Agency claims that all importation of prescription drugs--experimental
or FDA-approved--is technically illegal. I'm not convinced this is the
case. But even if it is, the question remains: if the FDA can make up
an importation system out of whole cloth, shouldn't such a system make
sense? If the FDA can use it's discretion to allow Americans to carry
experimental and FDA-approved drugs into the United States, shouldn't
the Agency be able to use that same discretion to allow Americans to
mail-order commonly-prescribed, FDA-approved drugs from countries like
Canada? Our goal, as I told Secretary Thompson, should be ``a clear and
logical, written regulatory program that allows consumers access to
imported, U.S.-approved drugs'' while stopping dangerous, unapproved
medicines imported without a prescription.
Supporters of prescription drug importation are often criticized
for jeopardizing patient safety. However, we must remember to balance
legitimate safety concerns with very real safety concerns for seniors
who cannot afford high American drug prices. Often living on fixed
incomes, it is not unusual for seniors to break pills in half to make
their prescriptions stretch further. At the least, taking the wrong
dosages detracts from a drug's desired effect. In addition, I believe
what safety concerns do exist might be solved by simply re-allocating
the FDA's current border enforcement resources. At present, the FDA
appears to be focusing its staff resources on the wrong borders,
intercepting what are almost certainly the safest drug packages.
According to the FDA's website, this year the FDA has stopped and
detained 18 times more packages coming from Canada (54) than from
Mexico (3). Last year, the FDA stopped 90 packages coming from Canada
and only one from Mexico. This is inexplicable, particularly given the
FDA's testimony today concerning dangerous medicines entering the
United States through Los Angeles.
In conclusion, the FDA must certainly address legitimate safety
concerns in its approach to mail ordered prescription drugs. However,
such concerns should not discourage the Agency from overhauling what
has become a confusing, contradictory array of written and unwritten
policies that prevent importation of safe, FDA-approved products. At
the end of the day, the FDA should not be standing between the American
consumers and safe, lower-cost prescription drugs.
I thank the Chairman again for the opportunity to contribute to
this discussion.
______
Congress of the United States
House of Representatives
May 2, 2001
The Honorable Tommy G. Thompson
Secretary of Health and Human Services
200 Independence Avenue SW
Washington, D.C. 20201
Dear Tommy: When you visited the House Budget Committee recently, I
mentioned my concern that the Food and Drug Administration (FDA) is
inappropriately interfering with mail order shipments of prescription
drugs from Canada for the personal use of Americans. I have looked into
this matter further, and I find that not only is the FDA acting in
violation of a new law requiring due process for mail order importers,
but the Agency's entire policy regarding personal use importation is
deeply flawed and inconsistently applied. I write to ask you to give
both problems your prompt attention.
Personal Use Policy
In the 1990s, the FDA evolved a written policy allowing individuals
seeking medical treatments not available in this country to bring drugs
not approved for use in the United States for their personal,
``compassionate use.'' Additionally, the FDA allowed licensed
practitioners in the United States to prescribe for their patients
drugs approved in a foreign country but not in the United States. In
the last few years, this sensible compassionate use policy has further
evolved into the current, unwritten ``personal use'' policy. Under the
personal use policy, the Agency allows individuals to bring up to a
three-month. supply of drugs into the United States, whether the drugs
are approved for use in this country or not.
This combination written/unwritten personal use policy is flawed
for a number of reasons.
First, it favors unapproved drugs over approved drugs. Written FDA
policy explicitly allows foreign, unapproved drugs into the United
States (Regulatory Procedures Manual, Chapter 9). Yet that same written
policy explicitly rejects importation of products available
domestically. While I certainly agree that the very sick should have
formal access to unapproved products, it makes no sense to me that the
very poor should not have formal access to approved products. When I've
proposed extending the written ``compassionate use'' policy to
medications available in the United States, the FDA has responded that
such imports are technically illegal. While I am not convinced this is
the case, this argument, if true, would also destroy FDA's written
personal use exemption for unapproved drugs as well, as, according to
the FDA, that policy finds no basis in the law either. My point is
this: if FDA can compassionately use its discretion to allow, in
writing, experimental, unapproved drugs into the United States, it
surely ought to be able to use its discretion to allow, in writing,
common, FDA-approved medications into the United States--given the
FDA's position that both types of imports are technically illegal.
Second, the FDA's unwritten personal use policy favors drugs
carried across the border to drugs mailed across the border. This is
yet another layer of discrimination and inconsistency in the FDA's drug
importation policy. Under current FDA practice--which is what the
unwritten personal use policy amounts to--Americans are freely allowed
to carry common, FDA-approved drugs across the border on their person.
Yet, when the same individuals have tried to refill the same
prescriptions through the mail, the FDA has stopped the packages,
opened them, and sent importers threatening warning letters. (As you
know, this egregious aspect of the FDA's unwritten personal use policy
prompted me to write the Drug Import Fairness Act, which requires due
process to mail order importers. Unfortunately the FDA is violating the
letter and spirit of this law. I discuss this matter further, below.)
When approached on this disparate and illogical treatment of mail
orders, the FDA responds that all imports of FDA-approved drugs are
technically illegal. Again, while I am not convinced this is the case,
this argument, if true, would also destroy the FDA's unwritten policy
of allowing FDA-approved drugs to be carried across the border. That
is, if FDA can use its discretion to allow approved drugs into the
United States if carried across the border, it surely ought to be able
to use its discretion to allow approved drugs if mailed across the
border--given, again, the FDA's position that both types of imports are
technically illegal.
In light of these flaws and inconsistencies, which only benefit
Americans wealthy enough to travel abroad, I am requesting that your
Department oversee an immediate revision of FDA's personal use policy.
Our goal should be a clear and logical, written regulatory program that
allows consumers access to imported U.S.-approved drugs, whether those
consumers live in San Diego or Kenosha. Given the FDA's apparently
broad discretion in these matters, why not have a policy that makes
sense for all Americans? I would love to sit down with you to discuss
how this might work.
Warning Letters
Another reason I believe the FDA's personal use policy is fatally
flawed is the immense difficulty I have had forcing the Agency to give
mail order importers a simple explanation of what the FDA believes the
importers are doing wrong. I mentioned earlier the Drug Import Fairness
Act, which required the FDA to give mail order importers due process.
Simply put, the law directs the FDA to advise mail order importers, in
detail, why the particular import appeared to violate the law,
The FDA has defied this law and is now holding up mail order
shipments from Canada and sending intimidating detention letters to
American consumers stating that the drugs, such as Lipitor, appear to
be unapproved and misbranded and therefore are refused admission--and
may be destroyed. While the letters state that the consumer is not
being accused of breaking the law, they state that the package appears
to be unapproved and they threaten the consumer that future shipments
may be denied entry thus sounding very much like the warning letters
the FDA was sending before. (Indeed, under the definitions section of
the Drug Import Fairness Act, these letters are, in fact, warning
letters.)
But what's most disturbing about the new letters is that, while
some of them cite which section of the law the packages appear to
violate (the Drug Import Fairness Act requires this of all such
letters), the letters do not give reasons, based on the facts of the
particular package, for making that determination. This is a patent
violation of the Drug Import Fairness Act (section 746(g)(1)(C)). It
also violates long-established case law (L&M Industries v. Kenter, 458
F.2d. 968, 970-71 (2nd Cir. 1972)).
I request that your Department examine the FDA's current policy
regarding letters to individuals mail ordering prescription drugs.
Specifically, I would like to know what the Agency will be doing to
fully comply with the Drug Import Fairness Act's requirement that such
letters ``state the reasons underlying the [FDA's]'' decision that an
import appears to be unapproved-including an explanation of the facts
involved in each specific imported package.
Our own FDA should not stand between sick seniors, living on fixed
incomes, and lower drug prices. Basic fairness won't tolerate it. And
neither will the Congress.
Thank you for your attention to both of these important matters.
Sincerely,
Gil Gutknecht
Member of Congress
Mr. Greenwood. The Chair welcomes our first witnesses, the
Reverend and Mrs. Edwin Rode. We thank you very much for coming
to Washington, and we thank you very much for your patience.
As I explained to you last night, you have to listen to us
first, and then we will listen to you. We are very pleased that
you have joined us. As we mentioned to you last night, you are
aware that the committee is holding an investigative hearing,
and in doing so, we have had the practice of taking testimony
under oath.
Do either of you have any objections to testifying under
oath? Seeing that you do not, the Chair also advises you that
under the rules of the committee that you are entitled to be
advised by counsel. Do you desire to be advised by counsel
during your testimony?
Mr. Rode. No.
Mr. Greenwood. Seeing your response in the negative, would
you please rise then and raise your right hand, and will swear
you in.
[Witnesses sworn.]
Mr. Greenwood. You are now under oath, and you may give
your testimony. You are recognized for 5 minutes, but you may
testify for as long as you care to. Thank you.
TESTIMONY OF REV. EDWIN AND HELEN RODE
Mrs. Rode. Good morning, Chairman Greenwood, and good
morning to the rest of the committee. My name is Helen Rode,
and this is my husband, Ed Rode. We are grateful for the
opportunity to speak before this committee to share what has
happened to our family.
Our son, Todd, was found dead in his apartment on November
16, 1999. We are convinced that his death was caused by drugs
that he obtained from a foreign country through the Internet. I
would like to tell you a little bit about our family. Todd's
death has changed the lives of all of us.
My husband is a retired United Methodist pastor. I am a
wife, a mother, and a homemaker. We moved from the Chicago area
to Athens, Georgia in 1992 when we retired.
Our daughter, Lisa, is a registered nurse. She and her
husband, Kevin, live in a suburb of Chicago with their
children, Nathan, Neal, and Claire. Our younger son, Curt,
lives in Knoxville and teaches in the English Department at the
University of Tennessee.
Todd was our middle child. Until the age of 15, he was a
high achieving child, interested in music and sports. In high
school, he began exhibiting the behavior of teenage depression
syndrome. He battled this illness the rest of his life.
Todd had the heart and soul of a musician and wanted to
make this his major in college. However, he was drawn to the
field of psychology and counseling. He graduated magna cum
laude with a major in psychology and a minor in music. The
faculty named him the outstanding senior in the Psychology
Department.
Todd worked for several years as a counselor with young
people in a hospital setting. Discovering that this was not
good for his own mental health, he took a post-graduate course
at DePaul University in Chicago to become a computer
programmer.
He worked in this field for a number of years, constantly
fighting bouts of depression and anxiety. Periodically, he
would check himself into the hospital, but become anxious about
insurance coverage and check himself out.
At the time of his death, Todd was on disability leave and
losing his job and health insurance. During this time he was
under the care of a psychiatrist and counselor at a mental
health facility in Chicago.
In October 1999, when no one in the family could reach Todd
by phone or E-mail, we became seriously alarmed. We assumed
that he had checked himself into a hospital without telling us,
or was too sick to be in communication with anyone.
My husband called the Chicago Police Department on November
16, 1999 and they, along with his sister, went into Todd's
apartment and discovered that he had died. When our daughter
went to his apartment, she gathered all the medications she
could find.
It was at this time that we learned that Todd had ordered
controlled drugs from a pharmacy and doctor in another country.
In going through Todd's records, we could trace the Internet
source, the medications ordered, the date they were ordered,
and how he paid for them.
These drugs were Venlafaxine, Propoxyphene, and Codeine.
All of these drugs are controlled substances, which were
secured from an overseas pharmacy without any safeguards. The
report of Chicago's Medical Examiner and Coroner stated that
Todd's death was due to an accidental massive overdose of these
drugs.
After a few weeks of numbing grief, I began to feel intense
anger that someone as ill as our son could be tempted to obtain
medication that required nothing but filling out a
questionnaire on the Internet.
We tried to channel that anger into action. We sent a
letter to every elected official and agency that we could think
of. We were pleased that we received replies from most of these
letters.
Agents from the FDA and Customs Departments in Atlanta came
to our home in Athens on two different occasions. We gave
copies of all our information to them. Sometime later, they
contacted their counterparts in Chicago, who then visited our
daughter and took from her the medications that Todd had
received from the foreign pharmacy.
This all happened a number of months ago, and we had heard
nothing more until a counsel from Chairman Greenwood's
committee called us. He told us about this hearing concerning
Internet use to order drugs from foreign countries.
We then sent to him all of our information regarding Todd's
use of the Internet to obtain these drugs. It was then asked by
this counsel if we would be willing to speak to this panel and
tell our story. We agreed to do this, knowing that other very
ill people and their families are suffering and grieving like
we are.
This grief extends beyond our immediate family. Todd's
aunts, uncles, cousins, friends, nephews and niece have felt
Todd's death very deeply. Todd will never hear Nathan play
saxophone in the middle school jazz band. He will not see
Neal's skills playing first base. He will never read Clare's or
Curt's poetry.
He will not grow into middle and old age with his brother
and sister. And, we, his parents, have lost a child of our
hearts. We are left to grieve, not only for the struggles that
he constantly faced in his life, but also the horrifying
circumstances of his death.
Our plea to you is to do whatever is possible to enact
legislation and allocate funds to the appropriate agencies to
control and eliminate this dangerous use of the Internet. We
want to thank you for permission to tell our story before this
committee.
[The prepared statement of Helen Rode follows:]
Prepared Statement of Helen Rode
Good Morning.
My name is Helen Rode. This is my husband Ed Rode.
We are grateful for this opportunity to speak before this
Committee--to share what has happened to our family. Our son, Todd, was
found dead in his apartment on November 16th of 1999. We are convinced
that his death was caused by drugs that he obtained from a foreign
country through the internet.
I would like to tell you a little bit about our family. Todd's
death has changed the lives of all of us.
My husband is a retired United Methodist pastor. I am a wife, a
mother, and homemaker. We moved from the Chicago area to Athens, GA in
1992 when we retired.
Our daughter, Lisa, is a registered nurse. She and her husband,
Kevin, live in a suburb of Chicago with their children, Nathan, Neal,
and Claire.
Our younger son, Curt, lives in Knoxville and teaches in the
English Department at the University of Tennessee.
Todd was our middle child. Until the age of 15, he was a high
achieving child, interested in music and sports. In High School, he
began exhibiting the behavior of teen-age depression syndrome. He
battled this illness the rest of his life.
Todd had the heart and soul of a musician and wanted to make this
his major in college. However, he was drawn to the field of psychology
and counseling. He graduated magna cum laude with a major in psychology
and a minor in music. The faculty named him the outstanding Senior in
the Psychology Department.
Todd worked for several years as a counselor with young people in a
hospital setting. Discovering that this was not good for his own mental
health, he took a post-graduate course at De Paul University in Chicago
to become a computer programmer. He worked in this field for a number
of years, constantly fighting bouts of depression and anxiety.
Periodically, he would check himself into the hospital, but become
anxious about insurance coverage and check himself out.
At the time of his death, Todd was on disability leave and losing
his job and health insurance. During this time he was under the care of
a psychiatrist and counselor at a Mental Health facility in Chicago.
In October of 1999, when no one in the family could reach Todd by
phone or Email, we became seriously alarmed.
We assumed that he had checked himself into a hospital without
telling us or was too sick to be in communication with anyone.
My husband called the Chicago police department on November 16,
1999 and they, along with his sister, went into Todd's apartment and
discovered that he had died.
When our daughter went to his apartment, she gathered all the
medications she could find. It was at this time that we learned that
Todd had ordered controlled drugs from a pharmacy and doctor in another
country.
In going through Todd's records we could trace the internet source,
the medications ordered, the date they were ordered and how he paid for
them. These drugs were Venlafaxine, Propoxyphene, and Codeine. All of
these drugs are controlled substances which were secured from an
overseas pharmacy without any safeguards.
The report of Chicago's Medical Examiner and Coroner stated that
Todd's death was due to a massive over-dose of these drugs.
After a few weeks of numbing grief, I began to feel intense anger
that someone as ill as our son could be tempted to obtain medication
from a source that required nothing but filling out a questionnaire on
the Internet.
We tried to channel that anger into action. We sent a letter to
every elected official and agency that we could think of. We were
pleased that we received replies from most of the letters.
Agents from the FDA and Customs Departments in Atlanta visited us
in Athens on two different occasions. We gave copies of all of our
information to them. Sometime later, they contacted their counterparts
in Chicago who then visited our daughter and took from her the
medications that Todd had received from the overseas pharmacy.
This all happened a number of months ago, and we had heard nothing
more until a counsel from Chairman Greenwood's committee called us. He
told us about this hearing concerning Internet use to order drugs from
foreign countries. We then sent to him all of our information regarding
Todd's use of the Internet to obtain drugs from a foreign country. It
was then asked by this counsel if we would be willing to speak to this
panel and tell our story. We agreed to do this, knowing that other very
ill people and their families are suffering and grieving like we are.
This grief extends beyond our immediate family. Todd's aunts,
uncles, cousins, friends, nephews and niece have felt Todd's death very
deeply.
Todd will never hear Nathan play saxophone in the middle school
jazz band. He will not see Neal's skills playing first base in
baseball. He will never read Claire's or Curt's poetry.
He will not grow into middle and old age with his brother and
sister. And, we, his parents have lost a child of our hearts. We are
left to grieve, not only for the struggles he constantly faced in his
life, but, also, the horrifying circumstances of his death.
Our plea to you is to do whatever is possible to enact legislation
and allocate funds to the appropriate agencies to control and eliminate
Internet access to drugs.
We want to thank you for permission to tell our story before this
committee.
Mr. Greenwood. Thank you, Mrs. Rode, for your testimony. We
know how difficult this is for both of you. We are indeed sorry
for your loss. Your son had prescriptions, or is it correct
that your son had prescriptions at one point? Both of you can
share that microphone and either one of you can respond to the
questions.
Mrs. Rode. All right.
Mr. Greenwood. Is it the case that your son at one point in
the course of his psychiatric care had prescriptions for
certain drugs; is that correct?
Mr. Rode. Yes, sir, that's true.
Mr. Greenwood. Do you know what they were?
Mr. Rode. At this point, I do not. Todd was very secretive
about that. He kept a lot of this information to himself. I
think he was embarrassed by his sickness, and at that point was
a very private person.
Mr. Greenwood. So you are not sure if he had prescriptions
prior to this for drugs?
Mr. Rode. I was sure that he did, yes, because he was under
psychiatric care.
Mr. Greenwood. So you assume so, although I understand from
talking to you last night that for reasons of confidentiality
the psychiatrist is not willing to share or not able to share
that information?
Mr. Rode. Well, we have of course talked to the--not to the
psychiatrist, but talked to the office of the psychiatrist, and
we never did talk to the psychiatrist. And we were told at that
time that we were not by law permitted to get the information
that we requested.
That the only people that could get that information was
the FDA and a subpoena.
Mr. Greenwood. Okay. But he certainly had no prescriptions
for the drugs that he obtained?
Mr. Rode. That's correct. That is absolutely correct.
Mrs. Greenwood. And he did not use a prescription to obtain
those drugs. And how many different drugs were found in his
body?
Mr. Rode. Three.
Mr. Greenwood. So Todd purchased three drugs and there was
no one able to monitor whether he should be taking any or all
of those drug?
Mr. Rode. That is correct, sir.
Mr. Greenwood. And no doctor, no psychiatrist, no
pharmacist to monitor that, let alone to describe to him the
interactions and the dangers of taking those drugs in certain
dosages.
And I would assume that we don't know yet whether the
dosage, the actual dosage of the pills that he was taking, was
equal to what was written on the label; is that right?
Mr. Rode. I think that is correct. Todd was pretty astute
with understanding drugs, but I think that we--we assume that
the drugs that he received from overseas were probably heavier
dosages, and were not his proper dosage, even though on the
information that we received, in which the comptroller for this
particular group has--there was a dosage listed, but whether it
was the actual dosage that he received, we are not sure of.
Mr. Greenwood. Well, from what we have seen, when one
orders prescription drugs over the Internet from foreign
countries, there is no way of knowing what the drug that is
actually ingested contains.
And there is no way of knowing what is in it, or what the
dosage is, because the labels are often counterfeit, and the
container is counterfeit, and that is of course that we are
trying to get at here.
Mr. Rode. This hearing has opened up a new aspect to us of
the whole problem.
Mr. Greenwood. Right. Now, all of this information was
shared with the Food and Drug Administration how long ago?
Mrs. Rode. I am not sure when they first came to our house.
We sent our letter out to these agencies in July of last
year,and within a few weeks, I think we heard. I am not really
sure when they first contacted us.
Mr. Greenwood. Have they given you any indication to date
as to where their investigation has led them?
Mrs. Rode. No, we do not know that.
Mr. Rode. Prior to our coming here, we were in Chicago to
visit our daughter, and a person from Customs called and warned
us not to give the foreign country name or the pharmacist's
name.
Mr. Greenwood. Because there is an ongoing criminal
investigation----
Mr. Rode. Yes, sir, that is correct.
Mr. Greenwood. [continuing] underway, and hopefully we will
find the source of the drugs and prosecute the perpetrators if
there is evidence of criminal wrongdoing. I would yield back my
time and recognize for purposes of inquiry the gentleman from
Florida, Mr. Deutsch.
Mr. Deutsch. Thank you very much, and again, I know how
painful it must be for you to be here, and again thank you for
really sharing this with us. I think all of us are hoping that
by this hearing, and by our actions, and by your actions, we
can at least attempt to make sure that no other parents in
America would ever experience what you have experienced.
Do you have any specific suggestions of--I am asking maybe
beyond, but any recommendations of what you think Congress
should be doing to prevent these kinds of tragedies in the
future?
Mrs. Rode. Well, I think that the Oversight Committee--we
know nothing about all of this, let me assure you. But I feel
that it has to be approached from several different angles.
I think certainly the Legislature needs to be involved with
the laws, and see that the laws are carried out. If we need
more laws, and then the appropriate agencies, then we need to
do what is needed to be done.
Mr. Rode. They need to be funded in order to be able to do
the things that are required by the law. It is just a
horrendous problem. The Customs man, when he first came out, he
said that most of the Customs things came through Memphis, and
he said it was just impossible to investigate all of them.
We were kind of surprised that Customs and the FDA came
together. They both came together out to visit us twice.
Mr. Deutsch. Now, have you heard from any of the parents or
any of the relatives of people that this has happened to also?
Mr. Rode. No, sir, we have not; or from Customs or the FDA
either.
Mr. Deutsch. I thank you, and I yield back the balance of
my time.
Mr. Greenwood. I recognize Mr. Stupak for questioning.
Mr. Stupak. Thank you, Mr. Chairman. I am sorry to hear
about your loss. Let me just leave it at that. You indicated
that your son was taking heavier dosages than what he should
have been, and that is what you assumed, correct?
Mr. Rode. No, this is what the coroner and the medical
examiner's report told us.
Mr. Stupak. Was it a specific drug then that caused this?
Mr. Rode. We did name the drugs in our presentation.
Mr. Stupak. Is that drug obtainable in the United States?
Mr. Rode. I am not familiar with drugs, and so I can't
answer your question. I'm sorry.
Mr. Stupak. When we introduced our legislation last year,
we asked for simple things like the pharmacist, who is supposed
to be--when you go on the Internet, and you order your
prescription, there has to be a licensed pharmacist who would
display his license and certificate from the State where they
are practicing in.
We asked that there be a physical location, where you can
know whether it is in Menominee, Michigan, or Chicago,
Illinois, or wherever; as opposed to using some bogus address,
and you know it is really back in Thailand or China where these
drugs are being produced.
And then we put penalties in there if they did not have
these two simple requirements; a licensed physician or
pharmacist, excuse me, and a physical location. And we were
accused of trying to stifle freedom of speech under the
Internet, and trying to regulate the Internet.
Do you think that that is asking for too much of these web
pharmacy companies to at least display the license of their
pharmacist and a physical location so you will at least know
where they drugs are coming from?
Mr. Rode. I would hope that that would be essential. I
really do.
Mr. Stupak. I understand that there is some restrictions on
what we can say because of an ongoing investigation, but you
said something in response to a question from the Chairman
about some information that you would like to obtain. And is
that information from the FDA? Who is that that you would like
to obtain some information from?
Mr. Rode. We were told by the counsel that--in fact, we
have a session scheduled with Customs later in the day. We just
want to know what is being done. That's all. We have had no
knowledge at all, and we have been told nothing as to what is
being done. And coming back to your previous question----
Mr. Stupak. Before you do that, if there are some questions
that you need to know after you meet with counsel or the FDA,
and they don't tell you, would you let us know? Would you let
us know?
Mr. Rode. We will inform you; yes, sir, we will. We want to
cooperate in every way we can. That's why we are here.
Mr. Stupak. This is the Oversight Committee, and we have
extra power that we can get some of these things questioned. We
are not trying to stifle an investigation, but you certainly
have a right to know.
Mr. Rode. I understand.
Mr. Stupak. You had another question?
Mr. Rode. Well, coming back to your question, I think the
Freedom of Information is important, but I think that there are
some things that just can't be put out, you know? I think there
should be some restrictions.
And I don't feel telling the information that you were
suggesting about the Internet and the pharmacy, and the
pharmaceutical number or whatever it is, I feel that
information should be very vital to helping solve this kind of
problem.
Mr. Stupak. Well, when we started looking at this almost 18
months ago, some of us--there were maybe a dozen or two dozen
of these pharmaceutical sites, and when we had our hearing last
year, it was like 300 or 400, and now I think we are closer to
a thousand.
And we introduced our legislation, and we were told not to
worry, and that the Internet community will police ourselves,
and we will take care of that. Obviously, they are not, and the
number of websites continue to explode. And as I said in my
remarks, they are very attractive when you think you are
getting a good deal, and you think you are getting the drugs
that you want.
But as we have seen, whether it was L.A. or Dulles, it is
anything but what you can imagine is coming through, and people
are consuming it. They have no idea. You know, we are still
searching for a direction.
And we have other cases like yours throughout this country,
and it is time that we do something together as a Congress and
regulatory agencies in this country. That is what we rely upon
them to do for the American public, and to offer that simplest
degree of protection, and obviously they are not doing it.
Mr. Rode. Thank you.
Mr. Stupak. Thank you, Mr. Chairman, and I yield back.
Mr. Greenwood. The Chair thanks the gentleman, and
recognizes the gentleman from Florida, Mr. Bilirakis.
Mr. Bilirakis. Thank you, Mr. Chairman. Reverend and Mrs.
Rode, I, too, offer my sympathy. As I was on the elevator, and
I don't remember whether it was on the way up or the way back,
with Mr. Dingell, the Ranking Democrat, who sat over on the
other side, said Mike, we have got to do something about this.
Well, yes, I guess we do, but I don't know what. This is the
sort of thing that we are going to be looking at over a period
of time.
I am curious though. Let me ask you, and forgive me again
for bringing up Todd, but if there were warnings, educational
statements. For example public service announcements, where the
t.v. studios are required to offer so much time.
In other words, if there were warnings out there, would
Todd still have gone forward? Forgive me, but is that a
difficult question?
Mr. Rode. I think that is a hard question to answer,
because Todd's circumstances were that he was chronically
depressed, and chronically depressed people don't always make
the wisest decisions at certain times. And I think that more
needs to be done than just warnings.
Mr. Bilirakis. Yes, and I am not disputing that. Maybe
there is a lack of education out there, in terms of the
concerns. I knew someone going through medical school in
Australia, who befriended my family, and I guess somebody said
something about a bad stomach, and the next thing I knew, we
received this stuff from China in the mail that he made
arrangements for.
So, those things take place. Well, you understand. I had a
lot of confidence in the gentleman, but I didn't take it. But
again I wasn't sure. So I wonder if that might be of some help
from an immediate standpoint.
Mr. Rode. I am sure that it will be, but it is not the
total answer.
Mr. Bilirakis. No, it is not the total answer. All right.
Thank you, Mr. Chairman.
Mr. Greenwood. The Chair thanks the gentleman, and
recognizes the gentlelady from Colorado for questioning.
Ms. DeGette. Thank you, Mr. Chairman. I just echo what
everyone else has said, and let me say that part of the
frustration that this committee has had is the very nature of
the Internet, and how someone can go on a computer, and they
find a site that says this is a pharmacy, and order these
drugs, and fill out a questionnaire, and unlike a traditional
pharmacy, which has a physical location, the Internet doesn't
have that.
And so we are really stricken with a very high degree of
uncertainty as to what should the laws that we pass say. But
having said that, I think you heard in my opening statement and
others that some of us are very frustrated that we keep having
these hearings, and these drugs keep coming in.
And people like your son are dying, and it seems that there
is an approach. Congressman Stupak and others have a bill, and
I just want you to know that we intend to redouble our efforts
to both enforce existing laws to stop this from coming into the
country, and also to pass any news laws that we can.
But I think you have realized, and I think other families
like yours need to realize just passing a law banning this on
the Internet is not going to immediately stop it, because it is
hard to shut down these sites.
Having said that doesn't mean we shouldn't try. And I guess
I would just ask you a simple question, which is don't you
think that other families like yours, who maybe have not
experienced a tragedy yet, knew of the dangers and risks, and
knew of the regulatory challenges, they would support any
efforts Congress might make both to enforce existing laws and
to try to pass new laws?
Mrs. Rode. I certainly think so.
Mr. Rode. I would hope so.
Ms. DeGette. And I will yield the balance of my time to
Congressman Stupak.
Mr. Stupak. Thanks for yielding. In your statement here, we
have seen the drugs that your son was taking, and all of those
were controlled substances. Therefore, there should have been a
prescription. Do you know if with any of those containers there
was a prescription for him to receive these drugs?
Mr. Rode. What we picked up in his apartment, counsel has
that. So the prescriptions were listed.
Mr. Stupak. Was there a prescription with the packaging?
You see, underneath current law, and I am sure that someone
will correct me if I am wrong, but under current law, he could
not have even received them unless there was a valid
prescription with that package, because you have to have a
prescription with it. That's what I am asking.
Mr. Rode. Rephrase this question. I am having a little
trouble with it.
Mr. Stupak. Sure. In order for a drug to be received
through the mail in the United States, especially a controlled
substance, there has to be a number of requirements if it is
going to come through the m ail, and that's where he got the
drugs, through the mail, right?
Mr. Rode. That is our assumption, yes, sir.
Mr. Stupak. Okay. One of them is that there has to be a
prescription if it is a controlled substance.
Mr. Rode. Well, we did not find anything like that.
Mr. Stupak. And technically you can't even ship it without
a valid prescription and that is what is getting flooded in
this country.
Mr. Rode. Well, this is what we were told by Customs.
Mr. Stupak. Okay.
Ms. DeGette. I yield back, Mr. Chairman.
Mr. Greenwood. The Chair thanks the gentlelady, and
recognizes for 5 minutes for inquiry the gentleman, Mr.
Whitfield.
Mr. Whitfield. Thank you, Mr. Chairman, and thank you all
for coming today to help us examine what we might be able to do
to alleviate problems like this in the future. I just have a
couple of questions.
One, would you repeat for me the drugs that were involved
in this instance? I think you were pronouncing them, but I
wasn't sure. You said one was codeine?
Mr. Rode. One was codeine.
Mrs. Rode. The drugs that we were mentioned were the ones
that were named on the death certificate as being having toxic
doses, the ones that I mentioned earlier.
Mr. Whitfield. Okay. And do you have the spelling of those?
Mrs. Rode. Yes. I can spell it better than I can pronounce
it. It is b-e-n-l-a-f-a-x-i-n-e.
Mr. Whitfield. And what was the other?
Mrs. Rode. P-r-o-p-o-x-y-p-h-e-n-e. And the third substance
that was found to be toxic was codeine.
Mr. Whitfield. Okay. And all of those were listed on Todd's
death certificate?
Mrs. Rode. On Todd's death certificate, yes.
Mr. Whitfield. And how old was Todd?
Mrs. Rode. Thirty-eight.
Mr. Whitfield. Okay. And you know from which country this
came, but you have been requested not to talk about it?
Mr. Rode. That is correct.
Mrs. Rode. All this information has been given though to
the agencies.
Mr. Whitfield. Okay. And I think they will be here today,
and so I will yield back the balance of my time, Mr. Chairman.
Mr. Greenwood. The Chair thanks the gentleman for his
information. The common names of two of those drugs are Darvon
and Zanax. The Chair recognizes for inquiry for 5 minutes the
gentleman from Oklahoma, Mr. Largent.
The gentleman passes. Mr. Bass. The gentleman passes. In
that case, we have completed our inquiry. Again, Reverend and
Mrs. Rode, thank you so very much for coming to Washington to
testify, and you can be assured that this committee is going to
work very, very hard to come up with a solution so that this
doesn't happen to the parents of other Americans. Thank you
very much for coming.
Mrs. Rode. Thank you very much.
Mr. Rode. We appreciate all you have done, sir.
Mr. Greenwood. You are excused. The Chair then calls
forward the second panel, Dr. Donald Vereen, Office of the
National Drug Control Policy; Ms. Laura Nagel, of the Drug
Enforcement Administration; Mr. William Hubbard of the Food and
Drug Administration; Ms. Elizabeth Durant, of the U.S. Customs
Service; Dr. Alan I. Leshner, Director of the National
Institute on Drug Abuse; and Landon Gibbs, First Sergeant, of
the Virginia State Police. Will you please come forward and be
seated.
I thank the witnesses for their presence. You are aware
that the committee is holding an investigative hearing, and
when doing so, we have had the practice of taking testimony
under oath. Do any of you have objections to testifying under
oath?
Seeing no objections, the Chair then advises you that under
the rules of the House, and of the committee, you are entitled
to be advised by counsel. Do you desire to be advised by
counsel during your testimony?
Seeing no such interest, the Chair asks if you please rise
and raise our right hand, and I will swear you in.
[Witnesses sworn.]
Mr. Greenwood. Please be seated, and you are now under
oath. And we will recognize first for testimony Dr. Vereen.
Thank you, sir. You are recognized for 5 minutes.
TESTIMONY OF DONALD R. VEREEN, JR., DEPUTY DIRECTOR, OFFICE OF
NATIONAL DRUG CONTROL POLICY; LAURA M. NAGEL, DEPUTY ASSISTANT
ADMINISTRATOR, OFFICE OF DIVERSION CONTROL, DRUG ENFORCEMENT
ADMINISTRATION; ELIZABETH G. DURANT, EXECUTIVE DIRECTOR OF
TRADE PROGRAMS, U.S. CUSTOMS SERVICE; WILLIAM K. HUBBARD,
SENIOR ASSOCIATE COMMISSIONER FOR POLICY, PLANNING AND
LEGISLATION, FOOD AND DRUG ADMINISTRATION; ALAN I. LESHNER,
DIRECTOR, NATIONAL INSTITUTE ON DRUG ABUSE; AND LANDON S.
GIBBS, FIRST SERGEANT, VIRGINIA STATE POLICE
Mr. Vereen. Good morning. Chairman Greenwood, Ranking
Member Deutsch, and distinguished members of the subcommittee,
my name is Dr. Donald Vereen, and I have the distinct honor of
coming before the subcommittee today as the Deputy Director of
the Office of National Drug Control Policy.
First, as the father of two children, I want to extend my
heart-felt condolences to Reverend and Mrs. Edwin Rode on the
loss of their son, Todd. Drug prevention, education, and
treatment for youth and adults must remain the heart and soul
of our counter-drug efforts in the Federal, State, and local
levels of drug control.
On May 10, President Bush stated that the most effective
way to reduce the supply of drugs in America is to reduce the
demand for drugs in America. Therefore, this administration
will focus unprecedented attention on the demand side of this
problem. We recognize that the most important work to reduce
drug use is done in America's living rooms and classrooms,
churches, synagogues, mosques, the work place, and in our
neighborhoods.
ONDCP is committed to continuing to improve our drug
prevention efforts to avoid such tragedies in the future. I
want to thank the subcommittee for the opportunity to testify
on the subject of personal importation of controlled
substances.
ONDCP greatly appreciates your continuing interest in this
public health and safety issues associated with the importation
of pharmaceuticals. I realize that my time is limited, and I
will keep my opening remarks brief, and focused on ONDCP's
coordinating role in this issue. I respectfully request that
the subcommittee enter my written statement into the record.
Mr. Greenwood. That will be done, sir.
Mr. Vereen. ONDCP recently began to assist in coordinating
a response to the challenges posed by the personal importation
of controlled substances across the land border of the United
States.
Although ONDCP is well suited to provide assistance on
issues transcending the jurisdictional boundaries of several
departments and agencies, we recognize the institutional
expertise that resides in other agencies that are represented
here today.
The DEA, the FDA, the Customs Service, and NIDA, the
National Institute on Drug Abuse, are working closely together
to ensure that citizens of our country can continue to rely on
the guidelines established for using controlled substances in a
manner that maximizes health, safety, and efficacy.
The solution to these challenges is complex. We must
consider the interaction among a variety of statutes,
regulations, enforcement practices, research, and citizen
awareness.
Let me be clear that despite the challenges, the DEA and
FDA have assured us that they will continue to provide the U.S.
Customs Service with the guidance that they require to carry
out their mission relating to the importation of
pharmaceuticals effectively, and with limited inconvenience to
licit commerce and personal travel.
Since becoming involved in assisting and coordinating a
U.S. response to the personal importation of personal-use
pharmaceuticals, and in particular controlled substances, ONDCP
last month convened four separate meetings with the DEA, FDA,
U.S. Customs Service, and NIDA.
We have made substantial progress, and I believe that we
are moving forward toward forms of resolution. We know that
there is some diversion of legally produced pharmaceutical
controlled substances in the U.S., and that drug users and
traffickers also obtain these controlled substances from other
places. For example, Mexican pharmacies.
Both the U.S. and Mexican governments understand the issues
and will continue to work together to address them. In fact,
the DEA has two diversion investigators assigned to Mexico
City--where they are responsible for coordinating bilateral
regulatory efforts in any investigations of this sort of
diversion.
Turning to the science, we are fortunate to have NIDA
providing the scientific basis for our policies. In fact, I
would like to commend NIDA for the major initiative that it
recently launched on prescription drug abuse and misuse.
Unfortunately, there are a number of factors that indicate
prescription drug use and abuse are increasing. I will give an
illustrative example of this research, and I am certain that
Dr. Leshner will address this issue more completely in his
remarks.
In 1999, more than 9 million Americans, age 12 and older,
reported past year use of prescription drugs for non-medical
reasons.
That is from the National Household Survey from SAMHSA at
HHS. Of these 9 million people, one-quarter or more misused
prescription drugs for the first time the year prior to the
survey.
Furthermore, of these 9 million people, an estimated 4
million reported using prescription drugs for non-medical
purposes in the month prior to the survey. So, in conclusion,
developing policy and implementing procedures to manage
effectively the use and movement of controlled substances
requires a holistic, long-term, and research-based approach.
ONDCP is confident that the agencies involved will continue
to make steady and significant progress on all of those fronts.
Mr. Chairman, I am pleased to answer any questions at this
time, or whenever it is appropriate.
[The prepared statement of Donald R. Vereen follows:]
Prepared Statement of Donald R. Vereen, Jr., Deputy Director, Office of
National Drug Control Policy
introduction
On behalf of the Office of National Drug Control Policy (ONDCP), I
want to thank the Subcommittee for the opportunity to testify before
you on the subject of personal importation of controlled substances.
Chairman Greenwood, Ranking Member Deutsch, distinguished members of
the Subcommittee, we greatly appreciate your continuing interest in the
public health and safety issues associated with the importation of
pharmaceuticals. The critical oversight of this Subcommittee assists
ONDCP in its coordinating role in ensuring continuity and consistency
in the Executive Department and agency efforts to provide a
comprehensive response to the issue of personal importation and
potential diversion of controlled substances. This comprehensive
response is essential to our success in reducing drug use and its
consequences in our nation. We know that there is no single solution
that can effectively address this multifaceted challenge. Drug use
prevention, treatment, and research; as well as law enforcement,
protection of our borders, drug interdiction, and international
cooperation remain necessary components of our efforts.
coordination issues surrounding the personal importation of controlled
substances
As the Subcommittee is aware, ONDCP is a unique organization within
the Executive Office of the President that has the dual mission of
serving as the President's primary Executive Branch support for
counter-drug policy and program oversight while managing several
diverse programmatic responsibilities. ONDCP's policy role consists
primarily of developing national drug control policy, developing drug
control budget priorities, coordinating and overseeing the
implementation of that policy, and evaluating drug control programs to
ensure that federal departments and agencies remain focused and
coordinated for maximum efficiency and effectiveness.
ONDCP was recently asked to assist in coordinating a response to
the challenges posed by the personal importation of controlled
substances across the land border of the United States. ONDCP is
particularly well-suited to provide such assistance, as this issue
transcends the typical jurisdictional boundaries of one department or
agency. However, ONDCP recognizes the great institutional expertise
that resides in the other agencies represented today. ONDCP takes great
pride in the fact that the Drug Enforcement Administration (DEA), the
Food and Drug Administration (FDA), the United States Customs Service
(USCS), and the National Institute on Drug Abuse (NIDA) are working
closely together to ensure the citizens of our country can continue to
rely on the guidelines established for using controlled substances in a
manner that maximizes health, safety, and efficacy.
ONDCP is committed to supporting our inter-agency counterparts in
their efforts to implement a system with respect to the import of
controlled substances that draws the appropriate balances among the
need to prevent diversion, promote public health and safety by
permitting travelers to have the pharmaceutical controlled substances
they need, and the need for straightforward standards for Customs to
apply at our busy ports of entry. Clearly, the solution to these
challenges, is complex; it involves a variety of statutes, regulations,
enforcement practices, research, and citizen awareness. As with any
complex, multi-jurisdictional solution to a public health and safety
issue, the perfect solution will not be conceived, or implemented
overnight. There is no silver bullet approach; all affected departments
and agencies must bring their own expertise and authorities to bear if
we are to succeed. Recognizing that ONDCP only recently became involved
in this coordination, the DEA and FDA have advised us that they will
continue to provide the USCS with the guidance they require to carry
out their mission relating to the importation of pharmaceuticals
effectively and with limited inconvenience to licit commerce and
personal travel. Clear guidance is essential if we expect Customs
officials to continue their efforts, which typically process 1.3
million passengers and nearly 350,000 vehicles at ports and border
crossings across the United States each and every day of the year.
The cross-border diversion of pharmaceutical controlled substances
obviously has an international component. Some diversion of foreign
produced pharmaceutical controlled substances involves U.S. drug users
or traffickers who obtain controlled substance pharmaceuticals,
including Rohypnol and OxyContin, from Mexican pharmacies. The U.S.
government highlighted the need to better control the movement of
prescription drugs during the April 2-3, 2001, U.S/Mexico Senior Law
Enforcement Plenary. The Mexican government understands the issues and
agreed to address them, although they have not yet presented a specific
course of action. We will continue to follow-up with them. DEA has two
diversion investigators assigned to Mexico City where they are
responsible for coordinating bilateral regulatory efforts and any
investigations of this sort of diversion.
We cannot forget that the basis for our involvement is preserving
the safety of our citizens. In order to maintain credibility with those
we seek to protect, the approaches we employ must be rational and
research-based. We are fortunate to have NIDA providing the scientific
basis for our policies. In fact, I would like to commend NIDA for the
major initiative it recently launched on prescription drug abuse and
misuse, resulting in a Research Report on Prescription Drugs Abuse and
Addiction. NIDA should also be recognized for its ability to translate
its findings into clear, concise messages which it disseminates to
professionals and the general public alike.
Unfortunately, there are a number of factors that indicate
prescription drug use and abuse are increasing:
<bullet> In 1999, more than nine million Americans aged 12 and older
reported past year use of prescription drugs for non-medical
reasons. (National Household Survey on Drug Abuse)
<bullet> Of those nine million people, one quarter or more misused
prescription drugs for the first time the year prior to the
survey.
<bullet> Furthermore, of those nine million people, an estimated 4
million reported using prescription drugs for non-medical
purposes in the month prior to the survey.
<bullet> NIDA's Community Epidemiology Work Group which monitors 21
major U.S. metropolitan areas for community-level drug use and
abuse trends, also reports a general increase in abuse of
selected prescription drugs in several cities in recent years.
conclusion
Developing policy and implementing programs and procedures to
manage effectively the use and movement of controlled substances
requires a holistic, long-term, and research-based approach. While we
cannot expect to resolve these challenges overnight, we can and will
continue to make steady and significant progress on all fronts. Since
becoming involved in this issue, ONDCP has convened several inter-
agency meetings to identify the myriad of issues involved in maximizing
the effectiveness of our policy concerning the personal importation of
controlled substances across the U.S. land borders. ONDCP will remain
an active participant in the decision-making and implementation
processes.
We look to this Subcommittee, and indeed the entire Congress, to
continue providing bipartisan leadership in this effort. ONDCP is
committed to working within the Executive Branch, as well as with
Congress, state and local governments, international participants, and
private citizens to reduce drug use and its consequences in our nation.
Mr. Greenwood. The Chair thanks the gentleman and we will
hear from each of our witnesses, and then begin the
questioning.
Ms. Nagel.
TESTIMONY OF LAURA M. NAGEL
Ms. Nagel. Chairman Greenwood, Ranking Member Deutsch, and
other members of the subcommittee, I would like to thank you
for the opportunity to address the subcommittee regarding
current Federal law and DEA regulations which allow for the
importation of controlled substances under the personal medical
use exemption.
I would also like to extend my personal condolences to the
Rode family. Mr. Chairman, on behalf of Administrator Marshall,
I would like to thank the subcommittee for its interest and
support in assisting the DEA in carrying out our mission of
enforcing the Nation's drug laws.
The U.S. is party to two international treaties which
control the international trade in licit narcotic and
psychotropic substances: The United Nations Single Convention
on Narcotics of 1961; and the United Nations Convention on
Psychotropic Substances of 1971.
The DEA is designated as the U.S. competent authority for
ensuring the U.S. meets its obligations under these treaties. A
critical obligation is our regulation and control of the import
and export of licit narcotic and psychotropic substances.
The U.S. law pertaining to licit controlled substances is
contained in the Controlled Substances Act of 1970. Enforcement
of the CSA is the responsibility of the DEA. The FDA also plays
a critical role in regard to controlled substances.
As the Federal authority for regulating all controlled and
non-controlled prescription drugs from a health and safety
perspective, the FDA's authority is contained in the Food,
Drug, and Cosmetic Act.
Thus, controlled substances are subject to regulation by
both the FDA and DEA. Together, the FDCA and the CSA provide a
framework to protect the health and safety of the American
public, and collaboratively, the DEA and FDA strive for
consistent application of Federal laws.
Additionally, the United States Customs Service is
responsible for enforcing the import and export provisions of
the CSA at U.S. land borders. The CSA contains a personal
medical use exemption to allow international travelers, both
U.S. citizens and others, to leave and enter the U.S. with
controlled substances for their personal legitimate medical
use.
This exemption is consistent with the 1971 Convention on
Psychotropic Substances. The treaty clearly seeks to provide a
means to allow international travelers to carry personal use
quantities of controlled substance medications while visiting
foreign countries.
The CSA exemption does the same. However, neither the
treaty nor the U.S. statutes permit controlled substances to be
imported under the medical use provision via overnight courier,
unaccompanied baggage, parcel service, U.S. or international
mail.
Nor does the exemption permit one person to enter the U.S.
with controlled substances intended for the personal use of
another person. The Controlled Substances Trafficking
Prohibition Act was introduced in the U.S. House of
Representatives on April 1, 1998, to amend the medical use
exemption.
It was signed into law by the President on November 10,
1998. The Act addressed the fact that large quantities of
controlled substances were being brought into the U.S. from
Mexico by individuals misusing the exemption in order to divert
pharmaceutical controlled substances into illicit channels.
The bill amended the Controlled Substances Act to prohibit
any U.S. resident from entering the U.S. with more than 50
dosage units of a controlled substance through a land border
crossing with Mexico or Canada unless they could demonstrate
they possessed a valid prescription for the substance, and it
was issued by a properly licensed U.S. physician.
This does not mean that any U.S. resident may enter the
U.S. with up to 50 dosage units of a controlled substance, no
questions asked. Rather, the resident must satisfy all the
requirements set forth in 21 CFR 1301.26.
This includes the requirement that the importation is
authorized or permitted under other Federal and State law. For
example, if there is evidence that the drugs are not for
legitimate personal medical use, and the same person makes
repeated attempts over a short period of time to import new
packages of controlled substances for claimed personal medical
use, or the person has a variety of different controlled
substances under circumstances that are indicative of
diversion, the importation does not comply with either
9569a)(1), or the DEA regulations, and therefore must be
disallowed.
Since the passage of the Act, the DEA has received
information from the U.S. Customs Service that indicates that
individuals are circumventing provisions of the personal
medical use exemption.
We are currently considering ways of addressing this
problem, such as amending our regulation to provide the clarity
and guidance that the Customs Service needs to develop a clear,
concise, and enforceable policy for its inspectors at the
Nation's borders.
Before concluding, I would like to thank my colleagues at
the FDA and U.S. Customs Service, and ONDCP for their
cooperation in addressing this very important issue. Finally,
Mr. Chairman, I think you and the members of the subcommittee
for the opportunity to comment on this topic. I look forward to
addressing any questions that you may have.
[The prepared statement of Laura M. Nagel follows:]
Prepared Statement of Laura M. Nagel, Deputy Assistant Administrator,
Office of Diversion Control, Drug Enforcement Administration
Chairman Greenwood, Ranking Member Deutsch, and other members of
the Subcommittee, I would like to thank you for the opportunity to
address this Subcommittee regarding current federal law and DEA
regulations which allow for the importation of controlled substances
under the personal medical use exemption. Mr. Chairman, on behalf of
Administrator Marshall, I would like to thank the Subcommittee for its
interest and support in assisting the Drug Enforcement Administration
(DEA) to carry out our mission of enforcing the Nation's drug laws.
The United States is a party to two international treaties which
control the international trade in licit narcotic and psychotropic
substances: the United Nations Single Convention on Narcotics (1961)
and the United Nations Convention on Psychotropic Substances (1971).
The DEA is designated as the U.S. competent authority for ensuring that
the United States meets its obligations under these treaties. A
critical obligation is DEA's regulation and control of the import and
export of licit narcotic and psychotropic substances.
The U.S. law pertaining to licit controlled substances is contained
in the Controlled Substances Act of 1970 (CSA). Enforcement of the CSA
is the responsibility of the DEA. The Food and Drug Administration
(FDA) also plays a critical role with regard to controlled substances.
As the federal authority for regulating all controlled and non-
controlled prescription drugs from a health and safety perspective, the
FDA's authority is contained in the Food, Drug and Cosmetic Act (FDCA).
Thus, controlled substances are subject to regulation by both the FDA
and the DEA. Together, the FDCA and the CSA provide a framework to
protect the health and safety of the American public, and
collaboratively, DEA and FDA strive for consistent application of
federal laws. Additionally, the United States Customs Service is
responsible for enforcing the import and export provisions of the CSA
at U.S. land borders.
The CSA contains a personal medical use exemption to allow
international travelers, both U.S. citizens and others, to enter and
leave the U.S. with controlled substances for their legitimate personal
medical use. Specifically, Section 956(a) of the CSA, entitled
``Exemption Authority, Individual Possessing Controlled Substance,''
states that the ``Attorney General may by regulation exempt from
sections 952(a) and (b), 953, 954 and 955 of this title any individual
who has a controlled substance (except substances in Schedule I) in his
possession for his personal medical use, or for administration to an
animal accompanying him, if he lawfully obtained such substance and he
makes a declaration (or gives such other notification) as the Attorney
General may by regulation require.''
This exemption is consistent with the 1971 Convention on
Psychotropic Substances. Article 4 (a) of the Convention states, with
respect to psychotropic substances other than those in Schedule I,
parties may permit: ``The carrying by international travellers of small
quantities of preparations for personal use; each Party shall be
entitled, however, to satisfy itself that these preparations have been
lawfully obtained[.]'' The official commentary to the treaty explains
the purpose of this provision: ``[This provision] applies only to small
quantities needed for personal use, i.e. to such quantities as the
traveller may require during his journey or voyage and until he is able
to provide himself with the medicine in question in the country of
destination . . . In view of the express provision that each Party
(i.e. the countries of transit and destination) is entitled to satisfy
itself that the preparations have been lawfully obtained, it would be
useful to require the traveller to carry a medical prescription or in
cases in which the prescription is withheld by the pharmacist, a
duplicate or satisfactory copy of the prescription showing that the
preparations have been lawfully acquired.''
Clearly, the treaty seeks to provide a means to allow international
travelers to carry personal use quantities of controlled substance
medications while visiting foreign countries. The CSA exemption does
the same; however, neither the treaty nor U.S. statutes permit
controlled substances to be imported under the personal medical use
provision via overnight courier, unaccompanied baggage, parcel service,
U.S. or international mail. Nor does the exemption permit one person to
enter or depart the U.S. with controlled substances intended for the
personal medical use of another person.
As set forth in the DEA regulation on this issue, 21 CFR Section
1301.26, anyone who seeks to import a controlled substance for personal
medical use must satisfy all of the following requirements:
(a) The controlled substance is in the original container in which it
was dispensed to the individual; and
(b) The individual makes a declaration to an appropriate official of
the U.S. Customs Service stating:
1) The controlled substance is possessed for his/her personal use,
or for an animal accompanying him/her;
2) The trade or chemical name and the symbol designating the
schedule of the controlled substance if it appears on the
container label, or if such does not appear on the label,
the name and address of the pharmacy or practitioner who
dispensed the substance and the prescription number, if
any; and
(c) The importation of the controlled substance for personal medical
use is authorized or permitted under other Federal laws and
state law.
The ``Controlled Substances Trafficking Prohibition Act'' (``the
Act'') (Pub. L. 105-357), was introduced in the U.S. House of
Representatives on April 1, 1998, to amend the Personal Medical Use
Exemption. It was signed into law by the President on November 10,
1998. The Act addressed the fact that large quantities of controlled
substances were being brought into the U.S. from Mexico by individuals
misusing the exemption in order to divert pharmaceutical controlled
substances into illicit channels. The bill amended the CSA to prohibit
any U.S. resident from entering the U.S. with more than 50 dosage units
of a controlled substance through a land border crossing with Mexico or
Canada unless they demonstrate that they posses a valid prescription
for the substance, issued by a properly licensed U.S. physician. This
does not mean that any U.S. resident may enter the United States with
up to 50 dosage units of a particular controlled substance ``no
questions asked.'' Rather, the resident must satisfy all the
requirements set forth in 21 CFR 1301.26. States may impose additional
requirements as well.
For example, if there is evidence that the drugs are not for
legitimate personal medical use (e.g., the same person has made
repeated attempts over a short time period to import new packages of
controlled substances for claimed personal medical use; or the person
has a variety of different controlled substances under circumstances
that are indicative of diversion), the importation does not comply
either with Sec. 956(a)(1) nor the DEA regulations and must, therefore,
be disallowed.
Furthermore, the requirement specified in 21 CFR 1301.26(c)--that
the importation for personal medical use is authorized or permitted
under other Federal laws and state law--must be satisfied regardless
whether the person importing is a U.S. resident with no more than 50
dosage units of a controlled substance. For example, if a person were
seeking to import a particular controlled substance for personal
medical use, and the Food and Drug Administration advised the United
States Customs Service that importation of the drug should be
disallowed under the Food, Drug, and Cosmetic Act, the importation
would not comply with 21 CFR 1301.26(c) and would have to be denied.
In the same way, if a person sought to import a controlled
substance for purported personal medical use when entering the United
States in a border state that prohibits either the importation or
possession of the controlled substance, such importation must be
disallowed under 21 CFR 1301.26(c).
Since the passage of the Act, DEA has received information from the
United States Customs Service that indicates that individuals are
circumventing provisions of the Personal Medical Use Exemption by
making repeated trips across the border to obtain controlled
substances. We are currently considering ways of addressing this
problem, such as amending DEA's regulations to provide the clarity and
guidance that the Customs Service needs to develop a clear, concise and
enforceable policy for its inspectors at the Nation's land borders.
Before concluding, I would like to thank my colleagues at the Food
and Drug Administration, the United States Customs Service, and the
Office of National Drug Control Policy for their cooperation in
addressing this very important issue. Finally, Mr. Chairman, I thank
you and the members of this Subcommittee for the opportunity to comment
on this topic. I look forward to addressing any questions that you may
have at the appropriate time.
Mr. Greenwood. The Chair thanks the gentlelady for her
testimony, and recognizes Mrs. Elizabeth Durant from the U.S.
Customs Service for hers.
TESTIMONY OF ELIZABETH G. DURANT
Ms. Durant. Mr. Chairman, and members of the committee,
thank you for this opportunity to testify. I man Elizabeth
Durant, Executive Director of Trade Programs at the U.S.
Customs.
Today, I would like to discuss with you the U.S. Custom's
efforts to address the rising trend of personal and bulk
importations of pharmaceutical products into the United States.
I would also like to extend our sympathy on behalf of the U.S.
Customs to the Rode family.
The Customs Service enforces over 400 regulations for more
than 40 other Federal agencies at U.S. borders. These include
the laws that prohibit the importation of illegal or unapproved
pharmaceuticals that fall under the jurisdiction of both the
FDA and DEA.
The Customs Services is concerned with three particular
aspects of the importation of pharmaceuticals; those that are
purchased through the Internet and shipped through our
international mail facilities; those carried into the United
States by individuals transiting our land borders; and imports
of bulk shipments of pharmaceuticals.
The growth of the Internet has spawned a wave of
pharmaceutical purchases on-line. These purchases are most
commonly sent through the U.S. mail. We have Customs Inspectors
stationed at 14 international mail branches at postal
facilities across the United States to contend with these
shipments.
Detecting prohibited pharmaceuticals among the tens of
millions of parcels passing through our mail facilities each
year presents a massive challenge. Our limited resources
require a risk management approach with which we utilize
advance intelligence, records of past seizures, and other
factors to locate packages that present the most significant
threat.
Customs laboratories also play a critical part in our
investigations. Their expertise is world-renowned. We maintain
fully equipped labs at seven locations around the country. In
addition, we have three mobile labs to deploy at any point
along our borders.
We are confident in the forensic capability of our labs to
find discrepancies in shipments of bulk and finished
pharmaceuticals. But where we do require assistance,
specifically from the Food and Drug Administration, is in the
establishment of effective national standards for the
interdiction of pharmaceuticals subject to FDA laws.
The development of such standards is critical to customs.
To that end, we have been working closely with FDA to develop
the needed guidelines. We began by forming a joint task force
to examine pharmaceutical purchases shipped by U.S. mail.
The task force set up a pilot in Los Angeles at the Carson
mail facility. During that time the FDA detailed four full-time
employees, who observed first-hand the daunting volume of
packages screened by Customs every day.
Over a period of 24 work days, the FDA detained a total of
721 parcels, or just over 93 percent of this amount were denied
entry, and only 44 were released. It is important to note that
without the presence of FDA inspectors, U.S. Customs would have
had to detain 3,000 packages per week, or about 16,000 packages
over an equal time span under the existing guidelines provided
to your personnel.
In light of these results, we understand that the FDA is
revising its current policy to reflect a more practical and
workable approach. Customs is working with the FDA to devise
additional means to improve screening for these products.
However, we are awaiting the FDA's final policy before we
decide whether or not to move ahead with these initiatives.
Travelers who attempt to import pharmaceuticals upon their
return to the U.S. are also a source of concern.
Again, we are seeking guidance from FDA and DEA on this
front. Recently, Customs proposed a plan that more sharply
defines the current broad discretion given to Customs
Inspectors to decide whether or not an importation is for a
legitimate personal medical use. That plan is currently under
review by both agencies.
While the Customs Service is currently focusing a great
deal of effort on the interdiction of finished pharmaceuticals,
we also recognize the threat posed by the importation of bulk
pharmaceuticals.
In meetings with the Pharmaceutical Security Institute and
other members of the pharmaceutical security community, the
problem of counterfeit bulk pharmaceuticals continues to be a
priority.
PSI asserts the opinion that foreign trade zones that
produce finished pharmaceuticals habitually import cheap
counterfeit bulk pharmaceuticals to support their production.
In response, Customs initiated a multi-faceted counterfeit
pharmaceutical interdiction program called Operation Safeguard.
Operation Safeguard was carried out between September and
October of 2000 at the International Mail Branches at Dulles
Airport and Oakland, California. The operation was intended to
give Customs a snapshot of the types of pharmaceutical products
entering the United States.
That snapshot revealed that a vast percentage, perhaps as
much as 90 percent of the pharmaceuticals that enter the U.S.
via the mail do so in a manner that violates FDA and/or DEA
requirements.
Counterfeit pharmaceuticals enter in both wholesale and
retail quantities. Additional problems include expired
materials, products that have not been approved by the FDA,
products made in facilities not under proper regulation, and
products not having the proper usage instructions.
To offer an example, our seizures included a 3,000 tab
shipment of a counterfeit drug with an expiration date of 1980.
Under the second stage of Operation Safeguard, scheduled to
begin shortly, Customs will focus on bulk pharmaceuticals
processed in various facilities around the country, including
foreign trade zones. This will help us to determine the level
of counterfeiting taking place.
In addition, our Office of Investigations is continuing to
work with the FDA and DEA to combat the sale of prohibited
pharmaceuticals via the Internet. Customs' CyberSmuggling
Center is playing a leading role in these cases. Our efforts to
date have included a successful investigation with authorities
in Thailand that closed down seven on-line pharmaceutical sites
operating in that country.
Just last March, Thai authorities, again using information
developed by Customs, executed three search warrants at the
headquarters of an illegal Internet pharmacy marketing steroids
and Viagra.
From an overall perspective, a spiraling volume of goods at
our borders has put immense pressure on our ability to enforce
the Nation's laws while facilitating international trade. We
have taken many steps to address the anticipated challenges.
I want to thank you and the members of the committee for
considering the Customs Service in your review of the
importation of personal and bulk pharmaceuticals. This is an
issue that speaks directly to our mission.
We will continue to make every effort possible to work with
Congress and our fellow inspection agencies to address the
health and safety concerns of the American people. Mr.
Chairman, we have a short video. If you have time, we would
like to show you so that you can see.
Mr. Greenwood. Without objection, we would be delighted to
see the video.
[Video shown.]
Ms. Durant. This is a video of operations at our mail
facility at Dulles International Airport. You can see that the
mail comes to us on conveyer belts delivered from the Postal
Service. We x-ray all packages of foreign mail. From the x-rays
and other factors, based on the experience of our inspectors,
sort from this vast number to determine those that present the
greatest risk for evasion.
The Dulles facility receives approximately 70,000 packages
a week. I know, because I was just in Memphis that our Fed Ex
hub receives 70,000 packages a night. So it is quite a daunting
task for us to refine our sorting so that we have the best
chance of capturing those that are at most risk to the American
public.
You can see the kinds of drugs that come in through the
mail. They are not even in bottles many times, just loose in
paper. We have counterfeit drugs. We have grey market drugs. We
have prohibited drugs, and we have unapproved drugs, the whole
gamut of illegal substances through our mail facility at
Dulles. This is a situation that is pretty much replicated
around the country.
While many of the illegal substances are smuggled and are
hidden on purpose, some are just in packages, in boxes. I guess
they figure they will take their chances that we won't catch
them. This is a daily occurrence at Dulles. Thank you.
Mr. Chairman, I have a few examples to show you of the
kinds of things that we find that we know could not possibly be
for personal use. This first parcel is multiple types of
prescription drugs in a single package. This particular package
was imported from Thailand. We believe it's for black market
distribution in the United States. We believe that these kinds
of shipments then go to garage type pharmacies that may be
operating domestically in the United States, as well as the
ones overseas.
These are grey market drugs which are available in the
United States. We don't know what the strength of them is.
There is no guarantee that the user has the correct warning
implications, all the issues this committee brought up earlier
today about the supervision of taking prescription drugs that's
needed.
This is a scheduled substance. This is actually fen-phen,
which has been prohibited in the United States.
This substance is gammahydroxybutyrate, which is used in
conjunction with the date rape drug. It is used in club scenes
known as liquid X. It is linked to date rape because of the
confusion and unconsciousness that it causes.
This is your seizure, Mr. Chairman. This is the amylnitrate
labeled as Jungle Juice, that you saw when you were out at our
Dulles facility. So you can see it is an amazing array of the
different types of things that we're finding every day.
Thank you, sir. I will be happy to take questions later.
[The prepared statement of Elizabeth G. Durant follows:]
Prepared Statement of Elizabeth G. Durant, Executive Director of Trade
Programs at the U.S. Customs Service
Mr. Chairman, members of the Committee, thank you for this
opportunity to testify. I am Elizabeth Durant, Executive Director of
Trade Programs at the U.S. Customs Service. Today I would like to
discuss with you U.S. Customs' efforts to address the rising trend of
personal and bulk importations of pharmaceutical products into the
United States.
The Customs Service enforces over 400 regulations for more than 40
other federal agencies at U.S. borders. These include the laws that
prohibit the importation of illegal or unapproved pharmaceuticals that
fall under the jurisdiction of both the FDA and DEA.
The Customs Service is concerned with three particular aspects of
the importation of pharmaceuticals: those that are purchased through
the Internet and shipped through our international mail facilities;
those carried into the United States by individuals transiting our land
borders, and imports of bulk shipments of pharmaceuticals.
The growth of the Internet has spawned a wave of pharmaceutical
purchases on-line. These purchases are most commonly sent through the
U.S. mail. We have Customs Inspectors stationed at fourteen
international mail branches at postal facilities across the United
States to contend with these shipments. These facilities are located at
New York's John F. Kennedy Airport; Newark, New Jersey; Dulles Airport
in Virginia, Chicago, Detroit, Buffalo, Miami, Dallas, Charlotte,
Honolulu, Carson Airport in Los Angeles, Seattle, and Oakland/San
Francisco.
Detecting prohibited pharmaceuticals amongst the tens of millions
of parcels passing through our mail facilities each year presents a
massive challenge. Our limited resources require a risk management
approach, with which we utilize advance intelligence, records of past
seizures, and other factors to locate packages that present the most
significant threat.
Customs laboratories also play a critical part in our
investigations. Their expertise in analyzing everything from textiles,
to foreign oil, to food products to determine point of origin and
composition is world-renowned. We maintain fully equipped labs at the
following locations: New York; Chicago; Savannah; New Orleans; Los
Angeles; San Francisco and San Juan. In addition, we have three mobile
labs to deploy at any point along our borders.
We're confident in the forensic capability of our labs to find
discrepancies in shipments of bulk and finished pharmaceuticals. But
where we do require assistance, specifically from the Food and Drug
Administration, is in the establishment of effective national standards
for the interdiction of pharmaceuticals subject to FDA laws.
The development of such standards is critical to Customs. To that
end, we have been working closely with FDA to develop the needed
guidelines. We began by forming a joint task force to examine
pharmaceutical purchases shipped by U.S. mail. The task force set up a
pilot program in Los Angeles at the Carson mail facility. The pilot ran
for thirty days, from January 15th through February 15th of this year.
During that time, FDA detailed four full-time employees who observed
first-hand the daunting volume of packages screened by Customs every
day.
Over a period of twenty-four work-days, the FDA detained a total of
721 parcels. 677 parcels, or just over 93 percent of this amount, were
denied entry and 44, or six percent, were released for delivery by the
Postal Service. It is important to note that without the presence of
FDA inspectors, U.S. Customs would have had to detain some 3,000
packages per week, or about 15,000 packages over an equal time span,
under the existing guidelines provided to our personnel.
In light of these results, we understand that the FDA is revising
its current policy to reflect a more practical and workable approach.
Customs is working with the FDA to devise additional means to improve
screening for these products, such as implementation of a pre-approval
process and the installation of digital cameras in mail facilities to
supplement staffing shortfalls. However, we are awaiting the FDA's
final policy before we decide whether or not to move ahead with these
initiatives.
Travelers who attempt to import pharmaceuticals upon their return
to the U.S. are also a source of concern. Again, we are seeking the
guidance of the FDA and DEA on this front. Recently, Customs proposed a
plan that that more sharply defines the current broad discretion given
to Customs inspectors to decide whether or not an importation is for a
``legitimate personal medical use''. That plan is currently under
review by both agencies.
While the Customs Service is currently focusing a great deal of
effort on the interdiction of finished pharmaceuticals, we also
recognize the threat posed by the importation of bulk pharmaceuticals.
In meetings with the Pharmaceutical Security Institute (PSI) and other
members of the pharmaceutical security community, the problem of
counterfeit bulk pharmaceuticals continues to be a priority. PSI
asserts the opinion that foreign trade zones that produce finished
pharmaceuticals habitually import cheap counterfeit bulk
pharmaceuticals to support their production.
In response, Customs initiated a multi-faceted counterfeit
pharmaceutical interdiction program called ``Operation Safeguard''.
Operation Safeguard was carried out between September and October of
2000 at the International Mail Branches at Dulles Airport and Oakland,
California. The operation was intended to give Customs a snapshot of
the types of pharmaceutical products entering the United States. That
snapshot revealed that a vast percentage--perhaps as much as eighty to
ninety percent--of the pharmaceuticals that enter the U.S. via the mail
do so in a manner that violates present FDA and/or DEA requirements.
Counterfeit pharmaceuticals enter in both wholesale and retail
quantities. Additional problems include expired materials, products
that have not been approved by the FDA for usage, products made in
facilities not under proper regulation and products not having the
proper usage instructions. To offer an example, our seizures included a
three thousand-tab shipment of a counterfeit drug with an expiration
date of 1980 on it.
Additionally, it was found that many parcels contained different
types of pharmaceuticals that, if taken simultaneously, could cause
dangerous interactions. These products could easily be purchased by
individuals not under the direct supervision of a physician. Thus, we
cannot assume that they would be used properly.
It is important to note that after three weeks of Operation
Safeguard, the quantity of illegal and defective pharmaceutical
shipments slowed significantly.
Under the second stage of Operation Safeguard, scheduled to begin
shortly, Customs will focus on bulk pharmaceuticals processed in
various facilities around the country, including Foreign Trade Zones
outside the United States. This will help us to determine the level of
counterfeiting taking place.
In addition, our Office of Investigations is continuing to work
with the FDA and DEA to combat the sale of prohibited pharmaceuticals
via the Internet. Customs' CyberSmuggling Center is playing a leading
role in these cases. Our efforts to date have included a successful
investigation with authorities in Thailand that closed down seven, on-
line pharmacy sites operating in that country. As a result, we saw a
marked decrease in subsequent pharmaceutical seizures from Thailand.
Just last March, Thai authorities, again using information developed by
Customs, executed three search warrants at the headquarters of an
illegal Internet pharmacy marketing steroids and Viagra.
From an overall perspective, a spiraling volume of goods at our
borders has put immense pressure on our ability to enforce the nation's
laws while facilitating international trade. We have taken many steps
to address anticipated challenges, including refinement of our
targeting approach and development of a resource allocation model to
project future staffing needs across the country. But we still face a
daunting workload.
I want to thank you and the members of the Committee for
considering the Customs Service in your review of the importation of
personal and bulk pharmaceuticals. This is an issue that speaks
directly to our mission. We will continue to make every effort possible
to work with the Congress and our fellow inspection agencies to address
the health and safety concerns of the American people.
Mr. Greenwood. We thank you very much for your testimony.
The Chair recognizes Dr. Alan Leshner, Director of the--I
apologize. Next we will hear from Mr. William Hubbard of the
Food and Drug Administration.
TESTIMONY OF WILLIAM K. HUBBARD
Mr. Hubbard. Thank you, Mr. Chairman. I am joined by John
Taylor and Jeffrey Shuren from FDA in case we need further
expertise. I, too, have cluttered up your table, and I
apologize for that. Of course I have written testimony for the
record.
Mr. Chairman, the committee has been examining a number of
issues dealing with drug safety, counterfeiting, foreign
inspections, controlled substances, and personal importation. I
would like to focus today on the personal importation issue, if
I may.
When I testified here last May on Internet sales, I think
that we and the committee agreed that the State and Federal
authorities had the tools and the will to perhaps get some of
the domestic sites under control with various existing laws,
perhaps supplemented by new laws that might be necessary. But I
think we recognized at the time that the bigger problem was
foreign sites. We were very concerned about that. I think we
were right, because these things that Ms. Durant and others are
showing you and the things I have in front of me are evidence
of that.
We took some of the same sorts of samples and asked
physicians at FDA to tell us about them, what they are. Of
course, they do come in the same way that Ms. Durant stated--
this is one with four drugs in it, four packages. Inside is a
little bag of pills. We don't know what that is. So it's a wide
variety. We have injectibles from Spain. We have a seasonal
allergy drug that's approved here in a form, but this one is
not. We have an over-the-counter drug. We have an anti-
psychotic drug. We have drugs for heart conditions. We have
oxycontin. We have an interesting one here. This is labeled as
a seasonal allergy drug, but if you look more closely, inside
is a controlled substance. I'm not sure the folks at the ports
will be able to very easily make that distinction.
So we see a wide range of these sorts of products. They
really do pose risk. As you saw when you came to Dulles, they
come in packages with clothing and personal effects, all kinds
of things. They are very small packages that really overwhelm
our ability to do much with them.
So we have been examining this issue, Mr. Chairman. We have
been surveying the drugs that come in. We have been consulting
with our sister agencies, and we have been carefully
considering what to do about this. The inescapable conclusion
for us is that these drugs are virtually all unapproved in the
United States. They are provided without proper manufacturing
controls. They often lack instructions for safe use, and they
may be counterfeit, or worse. These factors, combined with the
rapid increase in the Internet that's caused the explosion of
these things, leads us to believe that they pose a risk to our
citizens that must be reduced.
So, accordingly, we have recommended to Health and Human
Services Secretary Thompson that he approve our recommendation
to request that the Customs Service deny entry of all of these
drugs, and to return them to their sender. We would create one
exception for patients with serious diseases, such as cancer,
who need an unapproved drug from a foreign country to save
their life, at least to give them hope of saving their life. We
would need to set up some sort of a compassionate use process
to allow those drugs in. But that would be the only exception.
I will say that if the administration agrees with us on
this, we are going to need to come back to the Congress,
because now the process requires us to give the recipients of
these products notice. If you take our data from the California
example and extrapolate it to an annual rate, it's perhaps 2
million of these a year at current rates, and perhaps growing.
We can't go through the process that we must now go to, which
is to mail a letter to the recipient, receive a response back,
and go through that 2 million times. We need to be able to make
a blanket assessment that these things are not safe for
American consumers and should be turned back. I believe the
Customs Service agrees with that. So if Secretary Thompson and
the administration agree, that will be the approach we intend
to take.
[The prepared statement of William K. Hubbard follows:]
Prepared Statement of William K. Hubbard, Senior Associate Commissioner
for Policy, Planning and Legislation, Food and Drug Administration
introduction
Mr. Chairman and Members of the Committee, I am William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation,
Food and Drug Administration (FDA or the Agency). I appreciate the
opportunity to discuss our mutual concerns related to the importation
of drugs into the United States (U.S.). This topic encompasses a range
of issues, including the importation by individuals of prescription
drugs at land borders or through the mail; the introduction into the
U.S. of controlled substances from foreign sources under the guise of
personal importation; the potential introduction of counterfeit bulk
drugs into the U.S. drug supply; and the purchase of drugs from foreign
sources over the Internet. We appreciate the leadership this Committee
has taken in keeping these issues at the forefront. Let me begin by
discussing one of our greatest challenges in this area.
personal importation of drugs through the mail
The amount of prescription drugs for personal use imported through
the mail has increased in recent years. According to testimony by the
U.S. Customs Service (Customs) before the Government Reform Committee
in May of last year, seizures of parcels containing scheduled or
controlled substances at international mail facilities increased by 450
percent in FY 1999, primarily due to drug sales over the Internet. We
estimate that approximately two million parcels containing FDA-
regulated products for personal use enter the U.S. each year through
international mail facilities that Customs could set aside for FDA
review for possible violations of the Federal Food, Drug, and Cosmetic
(FD&C) Act. This estimate is based on an extrapolation of data obtained
during a pilot project conducted at the international mail facility in
Carson, California (see below).
Under the FD&C Act, unapproved, misbranded, and adulterated drugs
are prohibited from importation into the U.S., including foreign
versions of U.S.-approved medications, as is reimportation of approved
drugs made in the U.S. In general, all drugs imported by individuals
fall into one of these prohibited categories.
From a public health standpoint, importing prescription drugs for
personal use is a potentially dangerous practice. FDA and the public do
not have any assurance that unapproved products are effective or safe,
or have been produced under U.S. good manufacturing practices. U.S.-
made drugs that are reimported may not have been stored under proper
conditions, or may not be the real product, because the U.S. does not
regulate foreign distributors or pharmacies. Therefore, unapproved
drugs and reimported approved medications may be contaminated,
subpotent, superpotent, or counterfeit. In addition, some foreign web
sites offer to prescribe medicines without a physical examination,
bypassing the traditional doctor-patient relationship. As a result,
patients may receive inappropriate medications because of misdiagnoses,
or fail to receive appropriate medications or other medical care, or
take a product that could be harmful, or fatal, if taken in combination
with other medicines they might be taking.
Personal Importation Policy
Under FDA's personal importation policy, as described in guidance
to the Agency's field personnel, FDA inspectors may exercise
enforcement discretion to permit the importation of certain unapproved
prescription medication for personal use.
First adopted in 1954, the policy has been modified several times
over the succeeding years. It was last modified in 1988, in response to
concerns that certain potentially effective treatments for AIDS
patients were not available in the U.S., but were available in other
countries. The Agency expanded the guidance for humanitarian purposes
to allow individuals suffering from serious medical conditions to
acquire medical treatments legally available in foreign countries but
not approved in the U.S.
The current policy permits the exercise of enforcement discretion
to allow entry of an unapproved prescription drug if:
<bullet> the product is for personal use (a 90-day supply or less, and
not for resale);
<bullet> the intended use is for a serious condition for which
effective treatment may not be available domestically (and,
therefore, the policy does not permit inspectors to allow
foreign versions of U.S.-approved drugs into the U.S.);
<bullet> there is no known commercialization or promotion to U.S.
residents by those involved in the distribution of the product;
<bullet> the product is considered not to represent an unreasonable
risk; and
<bullet> the individual seeking to import the product affirms in
writing that it is for the patient's own use and provides the
name and address of the U.S. licensed doctor responsible for
his or her treatment with the product or provides evidence that
the product is for the continuation of a treatment begun in a
foreign country.
FDA has not officially permitted the importation of foreign
versions of U.S.-approved medications, even if sold under the same
name, because these products are unapproved, and the Agency has no
assurance that these products are safe or effective, while safe and
effective versions are already available in the U.S.
FDA believes that the need for its personal importation policy is
far less now than it was when the current version of the policy was
developed in 1988. Now, due to faster review times and various
regulatory mechanisms through which patients can obtain unapproved
treatments for humanitarian purposes, the need to import therapies not
available in the U.S. has diminished. According to a Tufts University
study presented in September 2000, 80 percent of new molecular entities
approved in the U.S. in 1996 through 1998 received that approval within
a year of its first introduction on the world market, almost double the
rate during the years 1991 through 1995.
Implementation of the Personal Importation Policy
At mail facilities, Customs officials identify parcels that may be
violative of the FD&C Act. FDA inspectors then determine if these
products should or should not be permitted to enter the country. If
detained, FDA must issue a notice to the addressee describing the
potential Federal violation and provide the individual with an
opportunity to respond. If the addressee does not respond or provides
an inadequate response, FDA will give the parcel back to Customs to
have it returned to the exporter. Due to the requirements for notice
and the opportunity to respond, the process for detaining and further
processing mail parcels consumes large amounts of FDA resources. In
addition, much storage space would be needed to hold the large number
of detained parcels pending replies from the addressees.
FDA's personal importation policy, as written, is difficult to
implement. This is due, at least in part, to the difficulty faced by
FDA inspectors, or even health care practitioners, in identifying a
medicine by its appearance, and labeling may falsely identify a
product. From a practical standpoint, FDA inspectors cannot examine
drug products contained in a mailed parcel and accurately determine the
identity of such drugs or the degree of risk posed to the individual
who will receive these drugs.
FDA detains and refuses few mail imports for personal use. As a
consequence, the tens of thousands of parcels that FDA does not review
are eventually released by Customs and sent on to their addressees,
even though the products contained in these parcels may appear to
violate the FD&C Act and may pose a health risk to consumers. We do not
believe this is an acceptable public health outcome and are working to
develop a solution.
HHS Plan to Address Mail Imports for Personal Use
Due to the inability of FDA to cope with the volume of medications
imported for personal use through the mail, and because of the public
health risks associated with these products (as discussed below), FDA
has been working to develop a more effective personal importation
policy. In addition, we recognize that Customs is dependent on guidance
from FDA, and one of our goals is to provide clear and simple standards
for assessing parcels containing drug products. We are discussing
options for revisions to the Agency's personal importation policy with
Secretary Thompson.
carson mail facility pilot
Earlier this year, FDA and Customs conducted a survey of imported
drug products entering the U.S. through the Carson City, California
mail facility (the Carson pilot). The Carson pilot was proposed by
Customs as a means to examine incoming mail shipments of pharmaceutical
products over a specified time frame in order to identify both the
volume and the types of drug products entering the U.S. We also hoped
to better assess the efforts required to cover drug importations at a
mail facility, and to gain a better understanding of the public health
implications these importations may have for U.S. consumers.
The Carson pilot ran for a five-week period, with FDA inspectors
present for 40 hours per week. At the onset, Customs took a
``baseline'' sample in the first week by setting aside all
international packages that were suspect, or that they would have set
aside for FDA review had FDA been able to process them. The number of
packages set aside was approximately 3,300. Multiplying that number by
five weeks provides an estimated total of 16,500 international packages
(650 packages per day) that Customs could have set aside for FDA review
during the Carson pilot, if the ability to process them was not a
factor. After the first week, however, Customs actually set aside the
number of packages they believed FDA would be able to examine. In
general, during each week of the Carson pilot, more packages were set
aside than FDA was able to handle.
FDA was actually able to examine 1,908 packages during the five-
week pilot, an average of approximately 381 packages per week. Neither
FDA nor Customs kept a count of the packages that were set aside but
not examined. Unexamined packages were sent on to the addressees.
Of the 1,908 packages examined by FDA, 721 parcels were detained
and the addressees notified that the products appeared to be unapproved
for use in the U.S., misbranded and/or a drug requiring a doctor's
prescription. The parcels were shipped from a total of 19 countries,
and overall, there was no obvious evidence of the products being
imported for further commercial distribution. On average, the Agency
was detaining at a rate of 144 packages per week, or about 38 percent
of those examined.
Clearly, the Carson pilot demonstrated that the rate of packages
coming into the U.S. exceeds FDA's capacity to manage, thus, Customs is
left with little choice but to forward the majority of packages to
addressees. As we stated, we do not believe this is an acceptable
public health outcome, and we are working to develop a solution.
Analysis of the Carson Pilot Drug Parcels
In order to define better the nature of the risk to public health
from the types of products coming into the U.S. through personal
importation, FDA's Center for Drug Evaluation and Research (CDER)
reviewed listings of the products detained during the Carson pilot.
CDER's review demonstrates that there are serious public health risks
associated with many of the 721 drug shipments (composed of 197
different drugs) intercepted at Carson. In general, there are two types
of risks that consumers of these drugs would face. The first type of
risk is that associated with taking drugs of unknown origin or quality.
Second are the very significant risks associated with taking many of
these drugs without first obtaining a physician's prescription and
without the continued oversight of the physician.
Risks Associated with Drugs of Unknown Origin or Quality
In general, FDA has no information to establish where these drugs
were actually manufactured and whether necessary current Good
Manufacturing Practice requirements were followed. There is also no
assurance that the drugs were packaged and stored under appropriate
conditions to avoid degradation or contamination.
Approximately eight percent of the shipments contained drugs that
could not be identified because they contained no labeling; some of
these contain only foreign language labeling. Most of these drug
shipments were contained in plastic bags; one shipment contained drugs
taped between magazine pages.
Several drugs do not appear to correspond with any U.S.-approved
drugs and the risks are therefore difficult to assess. One drug was
evaluated for FDA approval but was denied approval. This drug is
associated with cardiac abnormalities and its efficacy could not be
successfully demonstrated. Another drug approved abroad but not in the
U.S. is associated with medically serious gastro-intestinal
complications. Several shipments contained three drugs that were once
approved by FDA but have been withdrawn from the market based on
serious safety concerns, including:
<bullet> fatal arrhythmia and dangerous drug interactions;
<bullet> loss of white blood cells (agranulocytosis) associated with
fatal infections; and
<bullet> hemorrhagic stroke.
Risks Associated with the Absence of Physician Oversight
The vast majority of the shipments were identified as containing
prescription drugs, which by definition, have serious toxicities and
risks associated with them such that they are ``not safe for use except
under the supervision of a practitioner licensed by law to administer
such drug.'' (Title 21, United States Code, section 353(b)). Although
some foreign Internet sites might offer an online questionnaire, we
believe that very few, if any, require a prescription from a
practitioner licensed in the U.S. before dispensing such drugs to U.S.
residents. Moreover, after detention notices were issued to the
intended recipients of the 721 drug shipments, fewer than four percent
presented evidence of prescriptions to document their relationship with
a physician in association with the drugs purchased from abroad. The
lack of adequate English language labeling accompanying many of these
shipments exacerbates the risks associated with the absence of
physician oversight.
During the Carson pilot, as in normal practice, Customs generally
separated out controlled substances for processing by the Drug
Enforcement Administration (DEA) before the remaining shipments were
provided for FDA review. However, in FDA's review, six controlled
substances were identified, including lorazepam, codeine sulfate,
loperamide, chlordiazepoxide, chloral hydrate, and diphenoxylate. These
drugs have the potential to cause addiction or be abused. Life-
threatening overdoses are possible. A physician's prescription and
oversight are essential for managing these risks.
There are numerous drugs identified on the Carson list that are
intended to treat conditions that consumers need physicians to properly
diagnose. As a result, consumers who bypass physician diagnosis and
prescribing may be exposing themselves to risks and toxicities that
cannot be justified by offsetting benefits to those patients.
<bullet> For example, almost ten percent of the shipments were for
antibiotics, despite the fact that consumers are generally not
able to diagnose whether their symptoms are caused by bacterial
infections. The overuse of antibiotics continues to be a
serious public health concern because it is linked to the
growth of antibiotic resistant-bacteria.
<bullet> Several drugs listed are potent steroids, which are generally
prescribed for conditions that are not self-diagnosable. In
addition, potential adverse events associated with these drugs,
including diabetes, hypertension, and serious infection require
prompt attention and careful monitoring.
There are many drugs on the list for which it is essential that the
proper dose be delivered into the bloodstream at the proper rate. Some
of these drugs have a narrow range in which they can safely achieve
their therapeutic effect. At least seven such drugs were identified on
the Carson list. Without FDA oversight, there is the risk that these
drugs may not have been manufactured with the necessary quality
controls to ensure a consistently safe and effective product.
<bullet> One seizure medication on the Carson list, for which there
were three shipments, could be very dangerous if not
manufactured to these rigorous standards. Any change in potency
could render the drug ineffective or highly toxic.
<bullet> Another seizure drug on the list for which physician
monitoring is also essential has a narrow therapeutic range and
FDA labeling provides a black-box warning for hepatoxicity,
teratogenicity, and pancreatitis.
More than 30 drugs on the list have serious contraindications and/
or drug interactions for which physician oversight is essential. For
instance, almost 20 percent of the shipments were for various estrogen
products for which there are multiple serious contraindications that a
physician needs to consider before making prescribing decisions and in
monitoring the patient.
It is impossible to make a scientifically definitive statement on
the public health impact of the drug shipments encountered during the
Carson pilot without extensive chemical testing and analysis of the
incoming pharmaceuticals, which would be prohibitively expensive. Based
on the observations noted above, however, FDA believes that these drugs
pose substantial risks to the public health, and we further believe
that significant changes to the policies governing personal
importations through the mail are warranted.
border surveys
Over the last year, FDA has initiated three other surveys to gather
data on drug products imported by individuals into the U.S. Although
these border surveys involve land traffic rather than mail importation,
the results of these surveys show some similarities to the findings
from the Carson mail pilot, as well as some significant differences.
Southwest Border Survey (August 2000)
A survey of prescription drugs being brought by pedestrians into
the U.S. at eight ports of entry along the 2,000 mile border with
Mexico was conducted by FDA's Southwest Import District (SWID) with the
assistance of other agencies including Customs, the DEA, the U.S.
Department of Agriculture, and others. The survey looked at activity
during four hours on a Saturday (August 12, 2000) at eight border ports
in California, Arizona, and Texas. The purpose of the survey was to
interview individuals walking across the border into the U.S. from
Mexico who had purchased prescription drugs in Mexico to determine 1)
what specific types of products are being imported, and 2) who is
importing these products.
The data collected from over 600 interviews indicated that the most
common importer of prescription drugs during the survey was an older
male Caucasian with a prescription from the U.S., bringing back
primarily antibiotics or pain relievers for his own use. Prescriptions
were held by 63 percent of the persons interviewed (59 percent U.S.
prescriptions and 41 percent Mexican). The most common drugs and their
indications that were purchased in Mexico during the survey were as
follows: Amoxicillin (antibiotic), Glucophage (diabetes),
Premarin (estrogen), Dolo Neurobion (vitamin supplement), Vioxx
(inflamation), Retin-A (acne), Tafil (anxiety), Celebrex (arthritis),
Penicillin (antibiotic), Viagra (impotence), Carisoprodal (analgesic).
Canadian Border Survey
On January 6, 2001, in cooperation with Customs, FDA conducted a
survey to obtain a snapshot of prescription drug products being brought
into the U.S. from Canada via passenger vehicles. During the eight-hour
survey at three ports of entry in New York, Michigan and Washington, a
total of 10,374 passenger vehicles and 58 buses crossed into the U.S.
Of these, 33 passenger vehicles (35 individuals) were referred by
Customs to be interviewed. These individuals brought in a total of 47
containers of drug products from Canada.
The types of products included pain medicines--primarily ``222'' (a
combination of acetaminophen, caffeine, and codeine) or similar
products. The indicated reason for import was that the products were
available over the counter in Canada and cost less than in the U.S. The
next largest group of products was herbal products, with the reason for
importation being that the products were not available in the U.S.
Other products included Tobradex (antibiotic/steroid opthalmic for
individuals having laser eye surgery); Claritin and Allegra (allergies)
purchased over-the-counter (OTC) in Canada; Sibelium capsules (calcium
channel blocker); and a variety of OTC products sold in Canada and not
available in the U.S.
Southwest Border Survey (April 2001)
On April 11, 2001, FDA, Customs, and other agencies conducted a
survey of prescription drugs being brought into the U.S. at seven ports
of entry along the U.S./Mexican border. This survey coincided with both
Easter vacations from many colleges and the end of the ``snowbird''
season, when tourists from Northern states visiting along the Southern
border return home.
During the four hour ``blitz'' a total of 586 persons brought in a
total of 1,120 drugs. Approximately 56 percent had a prescription for
the medicines (61 percent were U.S. prescriptions, 39 percent were
Mexican). The most common drugs purchased in Mexico were: Amoxicillin
(antibiotic), Premarin (estrogen), Claritine (allergy), Terramicinia
(antibiotic), Ampicillin (antibiotic), Ibuprofen (analgesic),
Penicillin (antibiotic), Vioxx (inflammation), Tafil (anxiety), Dolo
Neuorobian (vitamin supplement), Glucophage (diabetes), Celebrex
(arthritis), Naproxen (analgesic), Retin-A (acne), Ventolin (pulmonary
disease), and Valium (controlled substance/nervous system depressant).
controlled substances
Although we do not know, nor is it possible to clearly determine,
the amount of controlled substances brought into the U.S. purportedly
for personal use, it is likely that such medicines are frequently
imported for resale and pose a public health risk. The Agency has been
working with both Customs and DEA to streamline and clarify Federal
import policies specifically related to the importation of controlled
substances.
Counterfeit Bulk Drugs
As we stated in testimony before this Committee last year, FDA
believes that the authenticity and quality of drugs dispensed in the
U.S. remains high. We do take very seriously, however, any allegation
regarding the possible counterfeiting or adulteration of imported bulk
drugs, also referred to as active pharmaceutical ingredients (APIs).
The Agency agrees that more should be done to help ensure that imported
bulk drugs (APIs) and finished drug products meet the requirements of
the FD&C Act. We are actively pursuing a number of initiatives to
better detect and prevent the importation of counterfeit or adulterated
APIs.
Let me provide the Committee with a brief update on the five
initiatives that we announced at the hearings last year.
1. In February 2000, additional funds were allocated to the Forensic
Chemistry Center (FCC) by the Office of Regulatory Affairs
(ORA) for sampling, analytical work and assessments of APIs
gathered through targeted inspections of importers.
During FY 2000, the FCC conducted 20 targeted inspections,
including nine at importers of foreign APIs, ten at domestic finished
dosage manufacturers and one at a domestic animal drug manufacturer.
The FCC collected more than 1,000 samples of 130 APIs and related
documents and records during the inspections. Samples of two drug
substances have been analyzed.
The information and results of analysis obtained during the
investigations indicate a need for follow-up at two foreign API
manufacturers. Provisions are being made to have ORA laboratories in
New York and San Juan assist in the analytical evaluation, and some
training has already been provided.
2. Make the FCC API database available electronically to all field
inspectors by January 2001.
Direct electronic access to the FCC's API database was made
available to all District offices beginning in January 2001.
Enhancements to the system's capabilities and training for the user
community are ongoing and we expect to complete these efforts by the
end of the current FY. Information continues to be added to the API
database, which currently contains 566 label images and other packaging
information for foreign APIs. This database is one important tool that
FDA can use to more quickly identify whether or not a product is
authentic or counterfeit.
3. Expand the Philadelphia pilot nationwide by the end of 2000.
A pilot program was begun in the Philadelphia District office in
1997, to provide import inspectors with access to information on the
approval status of drug applications, as contained in the Establishment
Evaluation System (EES) database maintained by CDER. Access to this
data allows inspectors to obtain relevant approval information in about
three to four minutes on any API entry, which increases the probability
of confirming that the API being offered for import is from a proper
foreign source manufacturer and is intended for use by an appropriate
end-user.
The program has now been expanded to all of our districts. In
December 2000, ORA provided training to field import personnel
nationwide on the use of the EES database. Since then, District Offices
have been actively using EES to insure that imported APIs are, when
required, shipped from a firm identified as an approved source in the
finished dosage manufacturer's new drug application (NDA). FDA's
inspectors report that access to EES information has been very useful
in helping to assure that the declared source and destinations of
imported APIs are appropriate.
The Operational and Administrative System for Import Support
(OASIS) records indicate that 12 API entries have been refused
admission since January 1, 2001, based upon the appearance that the API
was misbranded because it was not from an approved source for use in
the manufacture of a finished dosage drug requiring an NDA. OASIS
records indicate that under the guidance relating to the use of EES for
evaluation of API entries, FDA has detained 499 distinct entry lines of
imported APIs among 437 API entries since January 1, 2001. However, all
but the 12 refused shipments were resolved when Districts received
evidence that the API was intended for a use other than an application
finished dosage manufacturing process or was manufactured by an
approved source. Consequently, the vast majority of these entries were
released into commerce after FDA review.
4. Put all importers and customs house brokers on notice that they are
required to provide the name of the foreign manufacturer upon
entry into the U.S., and that the entry of their products into
the U.S. will be contingent upon it.
Last year, the Agency placed the import and customs broker
industries on notice regarding the existing requirement to provide FDA
with accurate data regarding the identity and location of the
manufacturer of imported drugs. Although these requirements were
previously communicated to importers and brokers on a number of
occasions, we were not satisfied with the level of compliance with this
requirement. On July 20, 2000, the Agency posted an updated version of
this requirement on the Internet with links to and from FDA's import
operations pages. On July 28, 2000, a Customs Automated Broker
Interface (ABI) system administrative message regarding this
requirement was issued to all brokers.
Compliance with this requirement is routinely assessed as the
Agency carries out filer evaluations and is one of the factors
considered in providing continued electronic filing privileges on
OASIS. Customs has informed FDA that these types of reporting failures
may be the basis for Customs civil actions. Since January 2001, FDA has
initiated four separate cases with Customs requesting broker penalties
against brokers who have failed to provide adequate or accurate data to
FDA when they filed entries. In three of these cases, Customs has
approved the requests, while a fourth case is pending. Since June 1,
2000, 12 filers have been removed from paperless status and are
required to submit paper entry documents due to their failure to
electronically transmit accurate data for a variety of FDA products.
5. Require domestic manufacturers to provide information to FDA when
they discover that the bulk materials they receive are
substandard, ineffective, or appear not to be from the approved
source.
FDA is concluding the process of drafting a proposed regulation to
require such reports, which would apply to both domestic and foreign
manufacturers. We appreciated the Committee's suggestion to initiate
this requirement.
Let me now provide you with a brief update on some other
initiatives.
API Quality Sampling and Analytical Surveys
ORA and CDER are planning to perform a sampling survey in FY 2002
targeting imported APIs for quality and, where indicated, authenticity
evaluation. This survey, which is now being designed by CDER and ORA,
will broadly evaluate the quality of foreign manufactured APIs, and
specifically target APIs that are potentially substandard or
counterfeit.
Information Technology (IT) Assessment and Enhancement
We know that one of the issues of great concern to the Committee is
the Agency's lack of a well-integrated IT system for the regulation of
drug imports. FDA currently relies on several independently developed
databases of critical information that need to be integrated.
Last July, FDA engaged the services of a private contractor to
assess the Agency's IT needs for import operations and to recommend
changes to provide field staff with ready access to the information
necessary for making informed admissibility decisions. ORA has already
implemented several IT enhancements. First, electronic access to Agency
data sources are being provided to all FDA resident posts, either by
wide area network (WAN) or by satellite technology. Second, ORA is
initiating the establishment of an enterprise portal system, which will
provide a common user interface to all of FDA's information databases.
The statement of work containing the technical requirements for this
project has been drafted and the Agency hopes to award a contract for
system design by July 2001. Through these initiatives, FDA plans to
provide more information to its field inspectors and investigators on a
much more consistent basis through a single information access point.
Joint FDA-Customs Pilot Targeting Broker Misdeclarations
FDA is currently piloting a joint operation with Customs in one
U.S. port to specifically target FDA filers that have demonstrated a
pattern of inaccurately declaring information material to FDA's
admissibility decisions (whether in drug entries or other regulated
commodities). Available remedies against repeat offenders include a
possible FDA request that Customs demand physical redelivery of the
shipments entered using inaccurate information, and an initiation of
broker penalties, which may be substantial. FDA has seen recent success
in initiating civil broker penalties when filers fail to provide
correct data for FDA's evaluation upon entry. Much of this success is a
direct result of cross training of FDA's import operations field and
headquarters personnel in Customs law and regulations and civil
remedies that are currently available to FDA when an importer or broker
fails to adhere to declaration or FDA examination requirements.
internet drug sales
Based on surveys conducted in early 2000 by Office of Criminal
Investigations (OCI) and subsequently by the General Accounting Office
(GAO), it appears that there are roughly 300 to 400 Internet sites
selling prescription drugs, with approximately half located
domestically and half located outside the U.S. FDA has long taken the
position that consumers are exposed to a number of risks when they
purchase drugs from Internet sites or other mail order outlets that
dispense foreign drugs. These outlets may dispense expired, subpotent,
contaminated or counterfeit product, the wrong product, a
contraindicated product, an incorrect dose, or medication unaccompanied
by adequate directions for use. FDA cannot provide consumers with any
assurance that these products were manufactured under current good
manufacturing practice standards. Taking an unsafe or inappropriate
medication puts consumers at risk for dangerous drug interactions and
other serious health consequences.
Internet sites that provide prescription drugs by having consumers
fill out a questionnaire rather than seeing a doctor pose serious
health risks. A questionnaire generally does not provide sufficient
information for a healthcare professional to determine if that drug is
appropriate or safe to use, if another treatment is more appropriate,
or if the consumer has an underlying medical condition where using that
drug may be harmful. FDA has undertaken widespread public relations
efforts to warn consumers about the dangers of buying drugs online, and
we have provided extensive information on these dangers on FDA's own
Internet site. FDA's Buying Medical Products Online web page is one of
the most frequently requested pages on FDA's website. It consistently
ranks among the top twenty requested pages, averaging almost 13,000
hits per month.
Currently, FDA has 90 sites under active review for possible
regulatory or civil action. Warning letters have been sent to 48
domestic online sellers. Additionally, FDA has sent 121 ``cyber
letters'' to operators of Internet sites offering to sell online
prescription drugs or unapproved drugs. These sites may be engaged in
illegal activity such as offering to sell prescription drugs to U.S.
citizens without valid (or in some cases without any) prescriptions.
Cyber letters are sent over the Internet to the suspect websites to
warn the operators that they may be engaged in illegal activities, and
inform them of the laws that govern prescription drug sales in the U.S.
While cyber letters may not be the most effective enforcement tool,
they certainly have a deterrent effect and FDA has seen positive
results from using them. FDA has received positive responses from
twenty percent of the cyber letter recipients and we are continuing to
monitor these sites.
FDA also sends copies of its cyber letters to the home governments
of targeted websites, when the locations can be identified. Follow-up
depends on the ability and willingness of the foreign regulatory bodies
to investigate and take actions against website operators who are
illegally shipping drugs to other countries.
In cooperation with the Department of Justice (DOJ), five
preliminary injunctions have been imposed on the sale of a illegal
products, including one product marketed as a weight-loss aid
containing a potent thyroid hormone which could cause heart attacks or
strokes, and an unapproved cancer therapy. FDA and DOJ also are
pursuing an injunction against the sale of another unapproved cancer
therapy over the Internet. Additionally, 15 product seizures, 11
product recalls, and the voluntary destruction of 18 violative products
have been achieved, generally pertaining to unapproved new drug
products including gamma hydroxybutyric acid, gamma butyrolactone ,
Triax, 1,4 butanediol, and laetrile. Thirty-six foreign shippers have
been placed on Detention Without Physical Examination and added to
Import Alert 66-57 for targeting sales of unapproved new drug products
to the U.S.
During FY 2001, FDA's OCI initiated approximately 40 Internet-
related investigations and will continue to conduct investigations
involving suspected criminal activity related to Internet drug sales as
well as other Internet-facilitated criminal violations of the FD&C Act.
Of the 133 currently open Internet-related investigations, 64 are
Internet pharmacy cases, where the focus is on the possible dispensing
of prescription drugs without a prescription.
In recent years, OCI has initiated 285 Internet investigations and
each of these investigations have involved a variable number of actual
websites--typically ranging from one to 25 or more. OCI has effected 88
Internet-related arrests, 70 of these in drug-related investigations.
Of the 70 drug-related arrests, 11 have involved Internet pharmacy
cases. These arrests have resulted, thus far, in 48 Internet-related
convictions, 42 of these in drug-related investigations. Of the 42
drug-related convictions, five have involved cases involving the sale
of prescription drugs without a valid prescription.
In addition, OCI has an ongoing initiative at the Dulles
International Airport Mail Facility that had its genesis in their first
Internet case, which began in 1994. The case, which involved a site
selling steroids over the Internet, resulted in a successful
prosecution and shutdown of the website. The partnership resulting from
this case has continued, and in the past 18 months, OCI has been
involved with local law enforcement in the Washington metropolitan area
in 98 drug seizures. The seizures represent dozens of types of drugs
coming in from 13 different countries. Of the 98 seizures, 87 of the
drug seizures were ordered over the Internet and mailed to U.S.
citizens; six were mailed to the U.S. by family or friends living
abroad; four were ordered via a 1-800 telephone number from Canada and
mailed to the U.S.; and one was transported via an airline passenger in
two suitcases from Romania. The efforts of OCI, Customs, and local law
enforcement have yielded the execution of eight search and seizure
warrants and led to the arrest and prosecution of nine people.
conclusion
Mr. Chairman, FDA remains concerned about any possibility that
counterfeit or otherwise unsafe drugs may find their way into the
American drug supply. We will remain vigilant as we refine and improve
the programs and procedures that we use to ensure the availability of
safe medications for consumers.
We appreciate the continued interest of the Committee in these
important issues, and look forward to continuing to work with you.
Thank you again for the opportunity to participate in today's hearing.
I will be happy to answer any questions.
Mr. Greenwood. The Chair thanks the gentleman for his
testimony, and calls upon Dr. Alan Leshner, Director of
National Institute on Drug Abuse.
TESTIMONY OF ALAN I. LESHNER
Mr. Leshner. Good morning, Mr. Chairman, members of the
committee. Thank you for the opportunity to join this
distinguished panel and comment on some of the scientific
aspects of prescription drug abuse. Like my colleagues, I would
like to extend our sympathy to the Rode family for their
terrible loss.
Let me start by emphasizing that from a public health point
of view, many substances can be two things at once. On the one
hand, medications like morphine and methylphenidate are
extremely effective when used properly as prescribed. They can
save lives, and they certainly improve the quality of life for
millions of Americans.
However, when these same substances are misused, they can
be highly addictive, dangerous, and even fatal drugs. Right
now, we are seeing the prescription drug misuse or abuse as
posing a major public health threat.
A variety of indicators that I have gone through in my
written statement in much greater detail suggests that
prescription drug misuse is increasing. For example, according
to SAMHSA's National Household Survey on Drug Abuse, more than
9 million Americans reported that they used prescription drugs
for non-medical reasons at least once in 1999. One-quarter of
them, over 2 million people, acknowledged that they had begun
their prescription drug abuse in that 1 year.
Now prescription drug abuse, of course, is not a new
problem. It has been around for a long time. What is
particularly alarming right now is the significant increase in
misuse and the increase in young, first-time users of these
drugs. The most dramatic increases are found in 12- to 17-year-
olds, and 18- to 25-year-olds. Depending on the specific drug,
between 60 and 90 percent of the abusers are in these age
groups. These adolescents and young adults of course are at
tremendous risk of wasting the potential of their lives.
Now we don't know for certain why people are abusing
increasing amounts of prescription drugs, but we believe that
the ready availability and all of the glorification of these
drugs are contributing to the problem. It has long been known
that changes in the perception of risk or changes in the
perception of harm always drive drug use rates. For that
reason, we and a variety of partners in April launched a major
prescription drug abuse education and research initiative to
try to get ahead of the increasing rates in prescription drug
misuse.
We also believe that people are developing their addictions
through different pathways. There is one group who are
intentionally abusing these drugs, just as one might abuse so-
called street drugs, like heroin or crack cocaine. But there
also appears to be another group who may initially begin to use
these medications appropriately as prescribed, but over time
they slowly begin to deviate from their prescription regimen
for some reason. Then they may find that they have become
addicted, without ever planning or attempting to abuse the drug
in the first place.
It is important to mention here, however, that it is
extremely rare for people to become addicted when medications
are taken as prescribed. As just one example, the combined data
from three clinical studies showed that in patients with no
prior history of drug abuse, using opiates for the treatment of
pain was associated with only seven cases of addiction out of a
total sample of 25,000 people. This tells us that pain can be
addressed safely using opiate medications without over-concern
about addiction, but only so long as patients are well educated
about their use.
The stimulate methylphenidate, known commonly as Ritalin,
is another example of a drug that's extremely beneficial when
used as prescribed, but can be very dangerous when abused.
I will stop here. I would be pleased to answer any
questions that you may have. I do want to thank you for
bringing added attention to this very important issue, and for
asking that biomedical science be a part of this hearing. Thank
you very much.
[The prepared statement of Alan I. Leshner follows:]
Prepared Statement of Alan I. Leshner, Director, National Institute on
Drug Abuse, National Institutes of Health, Department of Health and
Human Services
Mr. Chairman, and Members of the Subcommittee, I am pleased to be
here to present what science has taught us about psychoactive
prescription drugs and their potential for abuse. This discussion is
particularly timely given that the National Institute on Drug Abuse
(NIDA) has recently launched a major initiative on prescription drug
abuse and misuse. NIDA's renewed efforts to encourage more research
into this area and to educate the public about the consequences of
abusing prescription drugs is a preemptive strike on our part to
curtail what our surveillance systems suggest is a growing problem in
this country.
At the outset, I would like to emphasize that many substances can
be two things at once. They can be very effective medications when used
properly; and highly addictive, dangerous, substances when misused.
When used for legitimate medical purposes, controlled substances such
as morphine and diazepam (Valium<SUP>'</SUP>), improve the quality of
life for millions of Americans with debilitating diseases and
conditions. It is only when these medications are used improperly that
they begin to pose a serious public health threat. It is the increasing
use of these medications for purposes other than how they were intended
that is of growing concern to us.
Several indicators suggest that prescription drug misuse and abuse
are increasing in the U.S. population. We know that in 1999 more than 9
million Americans aged 12-and-older reported that they used
prescription drugs at least once in the past year for non-medical
reasons. One quarter or more of those 9 million people misused
prescription drugs for the first time in the year prior to the survey.
And 4 million reported that they used prescribed medications for non-
medical reasons in the past month. These data come from the National
Household Survey on Drug Abuse, supported by the Substance Abuse Mental
Health Services Administration.
NIDA's own Community Epidemiology Work Group, a network of
epidemiologists and researchers from 21 major U.S. metropolitan areas
who monitor and report on community-level trends in drug use and abuse,
are also seeing increases in abused prescription drugs. The latest CEWG
report, for example, reports that the opioid hydrocodone (e.g. Lorcet,
Lortab, Vicodin) appears to be one of the mostly widely abused
prescribed medications. The number of emergency room mentions of
hydrocodone has grown by 139 percent, or from 6,115 mentions in 1993 to
14,639 in 1999. Other prescribed drugs that are emerging on the scene
and are causing increases in emergency room visits, according to CEWG,
are oxycodone and clonazepam.
Prescription drug abuse is not a new problem. The significant
increase in the numbers of people misusing these prescription drugs is
what is new. From 1990 to 1998, for example, the number of individuals
initiating misuse or abuse of pain relievers increased by 181%, new
initiates to stimulants have increased by 165%; tranquilizers by 132%;
and initiates into sedative use have increased by 90%. The most
dramatic increases are found in 12-17 year-olds and 18 to 25 year-olds.
Females in this younger age bracket appear to be particularly
vulnerable to prescription drug abuse.
Determining one's vulnerability to addiction is an important part
of NIDA's research portfolio. The fact that we do not fully understand
what makes some individuals more vulnerable to addiction than others
makes our concern about prescription drugs even more compelling. There
are major differences among individuals in sensitivity to various drugs
of abuse. Using advanced technologies, we recently found that
differences in brain chemistry may be one of the factors that
predisposes people to respond differently to abusable drugs. Other
determinants of drug use preferences and patterns include genetic and
environmental factors, a possible underlying medical illness, as well
as factors such as the availability of drugs.
What is significant about the brain chemistry finding that I just
mentioned is that all abusable drugs--from alcohol and nicotine, to
cocaine, methamphetamine, and morphine--share some common mechanisms of
action. They all activate the neurotransmitter dopamine, which is part
of the reward pathway or pleasure center for the body. It is this
pleasurable effect that is likely the reason that 26.2 million
Americans used an abusable drug in the past year in 1999.
Although dopamine is a common factor among all drugs of abuse, each
class of drug acts at different sites in the brain to produce its
intended effect. For example opiates, such as morphine, codeine, and
oxycocodone, work predominantly at the mu opioid receptors found in the
brain and spinal cord, to block the transmission of pain messages to
the brain.
Another commonly abused class of drugs is the Central Nervous
System (CNS) depressants. CNS depressants modulate actions of gamma-
aminobutyric acid (GABA) to slow down normal brain function. This
resulting calming effect is what makes CNS depressants so useful in the
treatment of anxiety and sleep disorders. Barbiturates such as
mephobarbital and pentobarbital; and benzodiazepines such as diazepam
and alprazolam, are two categories of CNS depressant medications that
are commonly prescribed for anxiety and sleep disorders.
The final class of commonly abused prescription drugs that I will
briefly mention today is stimulants. As the name suggests, stimulants
are a class of drug that enhance brain activity. They cause an increase
in alertness, attention, and energy by displacing two of the brain's
key neurotransmitters, norepinephrine and dopamine, which in turn
increases blood pressure, heart rate, respiration, and blood glucose.
Stimulants such as dextroamphetamine, methylphenidate, and sibutramine
are generally prescribed for narcolepsy, attention-deficit
hyperactivity disorder, obesity, as well as depression, and asthma.
When taken properly all of these prescription drugs that I have
just mentioned can be extremely helpful in relieving a wide variety of
medical problems. It is when they are used non-medically, that
prescription drugs can be dangerous, addicting and even deadly.
Research has not yet completely revealed all the reasons why people
would abuse a prescribed medication. Some may just intentionally abuse
these drugs to receive the pleasurable effects, in the same way that
people abuse and become addicted to heroin or crack cocaine. Others
seem to begin to use them appropriately as prescribed, but then over
time they slowly begin to deviate from the prescription regimen and may
become addicted without ever intentionally setting out to abuse the
drug in the first place. It is important to note that physical
dependence does not equal addiction. Physical dependence can be
relatively easily managed, whereas addiction--the compulsion to use
drugs--is a chronic reoccurring illness that requires long-term
treatment.
As I mentioned earlier, the same substance can be both a very
effective medicine and a dangerous addictive drug. Morphine, is the
perfect example. Morphine is a powerfully addictive drug. However, when
it is used to treat pain it is an extremely beneficial medicine. The
medical use of prescribed opiates effectively relieves both chronic and
acute pain, and allows millions of individuals to function normally.
Addiction under these circumstances is very rare. In fact, the combined
data from three clinical studies found that in patients with no prior
history of abuse, opiates used for the treatment of pain was associated
with only 7 cases of addiction in a sample of about 25,000 people.
Another example of how beneficial medications can be when used as
prescribed can be seen with the stimulant methylphenidate, known
commonly as Ritalin<SUP>'</SUP>. Data accumulated over 30 years shows
that methylphenidate is a safe medication when appropriately used for
the treatment of attention-deficit hyperactivity disorder (ADHD). ADHD
affects about 3 to 5 percent of the general population and is now one
of the most visible childhood mental disorders. A number of studies
indicate that ADHD youth that are appropriately treated with stimulant
medications have a reduction in the risk of later substance abuse.
In conclusion, I would like to thank you for allowing me to be here
to have science be a part of your discussion on this topic. NIDA is
increasing its research efforts into this area and will be pleased to
keep you abreast of any new findings that emerge that may help guide
your policy decisions.
Mr. Greenwood. Thank you for your testimony.
The Chair recognizes for his testimony, Sergeant Gibbs.
TESTIMONY OF LANDON S. GIBBS
Mr. Gibbs. Good morning. My name is Landon Gibbs. I am an
Assistant Special Agent in charge of the Drug Enforcement
Division within the Virginia State Police. I supervise a unit
that concentrates solely on pharmaceutical drug diversion and
abuse.
I want to speak to you about three things basically this
morning. The first is a drug that's causing tremendous problems
within Virginia. It's called Oxycontin. I want to talk to you
about what that drug is, how it is abused, and more
importantly, I want to talk to you about how it is impacting
the communities in Virginia by the rapid onset of abuse. Then I
would like to address some of the personal importation that we
have made cases on in Virginia.
Oxycontin is a very effective pain drug.
Mr. Greenwood. Pull your microphone just a tad closer,
please, Sergeant. Thank you.
Mr. Gibbs. Oxycontin is manufactured to relieve from severe
to moderate pain, terminal pain, a very effective good drug
when used as prescribed. The problem comes in when it is used
otherwise.
The drug abuser in Virginia will take the drug and crush
it, and either chew it and swallow it, inject it, or snort it.
When the drug is crushed, it bypasses its time release
formulation, which gives the abuser the full impact of pure
Oxycodone in a rush. It creates a high similar to heroin.
When it is used in this fashion it becomes extremely
addictive, and the person gets hooked on it very, very quickly.
They develop a mindset that all they want is more and more of
the drug. They will do whatever it takes to obtain that drug.
This is how it is affecting the communities in certain
parts of Virginia. The crime rates, particularly property
crime, have skyrocketed in some of the rural areas where these
people are burglarizing homes to find anything they can to
sell, to buy the drug. There are increased armed robberies of
pharmacies, where they actually go in at gun point, bypass the
cash register, and go straight to the drug stock or ask the
pharmacy techs to give me the Oxys. That's all they are after.
The drug is extremely profitable if they can steal it, even
if they are not an addict, because it sells for about a dollar
a milligram on the streets. This drug is now available in 10,
20, 40, and 80 milligram strengths. So if I can steal a bottle
of 100 40-milligram pills, I have got $4,000 that I can sell
very, very quickly.
The abuse problem increases to the point that women will
become prostitutes to obtain money to buy the drug. They will
steal from their families. They don't work any more. It has
created a tremendous financial impact on those communities.
Unfortunately, the experiences that Mr. and Mrs. Rode told you
about today is not uncommon. Virginia has experienced about 50
overdose deaths related to this one drug within the last year.
It is not just one drug that causes the problem. As they
have mentioned today, there is significant number of drugs, but
the Schedule IIs are the ones that appear to be causing the
deaths of the people that abuse it.
Going back to the personal importation of the drug, we have
experienced that in Virginia. For a number of years, we heard
rumors about people bringing Oxycontin and other drugs in from
Mexico. With the system of allowing 50 dosage units per person,
again, we'll go back to the 40 or the 80-milligram pill. As you
can see, the financial incentive for a person to go across,
obtaining a drug such as Oxycontin in Mexico and bring it back.
We recently were working cases in cooperation with the DEA
and made several arrests of individuals who would go into
Mexico, and each person would bring 5,000 dosage units of
Oxycontin back. The pharmacists at the little border towns
would actually help them conceal the drugs on their body
because they knew that the Customs Service would x-ray packages
or bags, purses, and things like that. So they would tape or
hide the medication on their bodies themselves.
After they were arrested, this group of six submitted three
separate trips of obtaining 5,000 dosage units each to bring
back into Virginia to sell. They were arrested when they were
selling it back in the State.
In April of this year, I went to the border crossing at
Tijuana personally. Quite frankly, I was overwhelmed at what I
saw. It is hard to imagine the volume of vehicles and
individuals coming into the United States from Mexico. On this
particular day, I made a mistake and drove across the border. I
missed the exit. You are not supposed to do that with a rental
car, but I did. There was so much traffic coming back, I waited
in line for about an hour to get through the border crossing,
and was simply waved through, as were hundreds of cars. I
parked the car on the U.S. side and walked back into Mexico and
spoke with Customs officers working there. There were only
three that day, trying to handle the bus and foot traffic
across. I spoke to him about the problems that we are having
with people importing the drugs. He said if you look at the
volume of traffic that we have, you will understand why we are
so overwhelmed, that there is very little enforcement effort
that can be done.
They were doing as much as they could such as x-raying
purses and suitcases and things like that. But for the
individuals that were not carrying this baggage, they just
simply came across.
I watched a child of about 14 on roller blades make two
trips. He would go across the border into Mexico, roller blade
back across and meet some people in a parking lot on the U.S.
side, and then go back. I was quite certain of what that young
man was doing.
The importation is a serious problem. Most of the problems
that we are having with pharmaceutical drug abuse in Virginia
is through over-prescribing by physicians. They are just
prescribing, for example for Oxycontin, more than is truly
medically needed. That makes it available for sale on the
street. Then once the person that is abusing it becomes
addicted, then if the supply from the physician is cutoff, we
have arrested several doctors for this, then they will go to
Mexico or wherever they can to get it to bring it back in.
I have heard testimony today concerning having a valid
prescription to obtain the stuff and import it. The validity of
a prescription comes into play if you go on the Internet, fill
out a form, and supposedly a physician will look at it in
another State, perhaps, and issue a prescription.
Virginia passed a law last year that causes a prescription
to be issued by a physician only when a true doctor-patient
relationship exists. That code defines what that doctor-patient
relationship is. It says there must be some type of an
examination of the patient by the prescriber. That way, we are
hoping to try to stop some of this Internet stuff from even
getting a foothold in Virginia that way. So far, that has
worked very, very well.
I will be glad to answer any questions that you have.
[The prepared statement of Landon S. Gibbs follows:]
Prepared Statement of Landon S. Gibbs, Assistant Special Agent in
Charge, Bureau of Criminal Investigation, Drug Enforcement Division,
Virginia State Police
Good morning Mr. Chairman and members of the Committee. My name is
Landon Gibbs. I am an Assistant Special Agent in Charge within the Drug
Enforcement Division of the Virginia State Police. I thank you for the
invitation to speak with you today concerning the impact of
prescription drug abuse and the personal importation of one of the most
abused drugs.
My testimony will focus on three areas:
A brief description of the drug Oxycontin, it's intended use and how it
is abused
The impact on individuals and the community of Oxycontin abuse
Personal importation of prescription drugs
Oxycontin, its use and abuse
Oxycontin is a very effective analgesic, designed for moderate to
severe pain relief, chronic pain control and terminal cancer pain
relief. It is a time-released form of the narcotic analgesic Oxycodone.
Oxycodone has a high abuse potential and is similar to Morphine in
dependence liability.
Oxycontin is currently available in 10, 20, 40 and 80 mg tablets,
as the manufacturer has ceased shipment of the 160-mg tablet. Oxycontin
is pure Oxycodone, with no other active ingredients, as compared to
other analgesics such as Percocet, Tylox and Percodan. The time release
formulation allows patients 8 to 12 hours of pain relief from a single
dose.
There are relatively few known incidents of addiction, or physical
dependence, to Oxycontin when the drug is taken as prescribed by a
physician. It becomes highly addictive when the time release
formulation is bypassed by crushing the drug, then either inhaling the
powder or mixing the powder with water and injecting the solution. This
allows the abuser to receive the full effect of the pure Oxycodone
almost immediately. This creates an effect similar to illicit opioid
narcotics, such has heroin.
In Virginia, most of the Oxycontin sold on the street and abused
comes from legitimate prescriptions written by physicians. It is quite
obviously being over prescribed and prescribed to individuals who do
not need it for pain relief.
Impact of abuse on individuals and communities
Individuals who abuse Oxycontin by inhaling or injecting the
crushed tablets quickly become addicted. This creates a mindset in
which the only goal of the individual is to obtain more of the drug.
Interest in work, family and personal well being simply disappears. The
individual often develops a drug-seeking behavior in which jobs,
family, friends will all be sacrificed in an effort to obtain money to
buy more Oxycontin. Thefts of money or items to sell from family
members are all too common. Some result to prostitution or other
criminal acts to fund their habit. Oxycontin has a street sale value of
one dollar per milligram.
The community also suffers when Oxycontin, or other drugs, are
abused by a significant number of the population. Virginia has had over
50 deaths related to Oxycontin abuse, through overdosing or combining
the drug with other substances, such as alcohol or other prescription
drugs. In addition to the emotional tragedy of these deaths, the
financial impact on families, the community and welfare programs is
quite significant. In southwest Virginia, local police are overwhelmed
with the increase in property crime related to Oxycontin addicts. Armed
robberies and burglaries of pharmacies are becoming a very real
problem. Thefts from homes and business, writing bad checks, car
jacking and other crimes are increasing as the drug addicted
individuals seek anything they can sell for money to buy the drug.
In northern Virginia, a woman was arrested for illegal possession
of Oxycontin and teaching her 15-year-old son how to crush and inhale
the drug. In another case, an undercover buy of Oxycontin was made in a
home where a 10-year-old was crushing the drug and preparing to inhale
it, in the presence of his father. The drug is reportedly being widely
abused by college students.
Personal importation of prescription drugs
Over the last two years, rumors have been heard concerning the
street sale of Oxycontin that was obtained in Mexico. The price of the
drug is Mexico is approximately ten cents per milligram. The street
resale value in Virginia is one dollar per milligram. Under current
federal guidelines, an individual is permitted to bring in up to 50
dosage units of a prescription drug. If that individual purchases 50
Oxycontin tablets of 80 mg each, he or she would pay approximately $400
in Mexico. That same amount would be worth $4,000 on the street in
Virginia. I believe that what is taking place is that groups of people
are making multiple border crossings in a short period of time to
import this drug. The profit margin is very high. There is no risk of
being detained at the border as no laws have been violated at this
point.
The State Police, working with the Drug Enforcement Administration,
have made several arrests of individuals selling Oxycontin that was
obtained in Mexico. These individuals were traveling to Mexico and
obtaining 5,000 dosage units each per trip. In statements made after
their arrest, they said they purchased the Oxycontin for 10 cents per
milligram and the Mexican pharmacists helped them conceal the drugs on
their body. These individuals made at least three trips to Mexico and
none were ever checked entering the United States. They remarked that
as long as a person did not carry any bags or a large purse, the
Customs officers would not do any serious checking or questioning.
In April of this year I visited the border crossing at Tijuana. The
volume of vehicle and foot traffic entering the United States
overwhelms the efforts of both the Immigration Service and the Customs
Service. On this particular day there were only three Customs officers
at this border crossing. One was assigned to deal with bus traffic and
the other two dealt with foot traffic. I spoke with one Customs officer
who stated that it is impossible for them to really check what is being
imported. Hundreds of vehicles were streaming into the United States.
On this day I did not see any being searched.
The importation of prescription drugs is a serious problem. If the
importation is for a true medical need, then the issue of why such a
significant price discrepancy between the United States and other
countries is a matter of concern. And if the 50 dosage unit regulations
stay in place, should the returning U. S. citizen be required to
produce a copy of a U. S. issued prescription? If the importation is
not based on medical necessity, then no amount should be permitted into
this country.
Finally, all the importation regulations are, in reality, useless
unless there is an effective system in place at the border to enforce
them.
I thank you for the opportunity to speak with you today and will be
glad to answer any questions.
Mr. Greenwood. Thank you for your testimony.
The Chair recognizes himself for 5 minutes for inquiry.
When we went out to Dulles Airport, we saw the overwhelming
number of packages that were coming in. We saw how many of them
contained pharmaceuticals, but we also saw that not only is
Customs completely overwhelmed by the flow of illegal drugs
into this country, but FDA completely overwhelmed given its
current regime.
It seems to me we have two choices. We can throw up our
hands and say it's an overwhelming volume coming in through the
mail, an overwhelming volume coming across the border in
Mexico. We don't have the manpower. We don't have the resources
to do anything about this. Then we can continue to bury kids in
this country. We can bury kids as the Rodes did, 50 overdoses
from one drug alone in Virginia. Or we can get serious about
this and get down to a tolerance level that puts an end to
this.
Now I am very pleased to hear the testimony from the Food
and Drug Administration today that the recommendation has been
made to the Secretary of Health and Human Services that in fact
we don't throw our hands up. In fact, we get down to
essentially zero tolerance. This is, to me, good news.
Now the question will be it is one thing to say that. It is
one thing to say every single package that comes into the
United States that has a drug in it, pharmaceutical product,
legal in this country, not legal in this country, with a
prescription, without a prescription it is going to be turned
down except for a very minute percentage that might be for
compassionate use. The question is, can that be implemented?
I want to address that question first to Customs, because
you are first online. Then to the FDA. We are delighted that
you come here to this hearing and tell us that this is going to
be essentially a zero tolerance. The question is, can that be
implemented? Are we likely to hear from the Health and Human
Services Secretary that this will be the policy, go to work,
shut this stream of dangerous drugs down, and feel that we have
solved this problem? Or are we likely to hear that it is a nice
idea, but it is impossible to enforce and we can't do it.
Ms. Durant?
Ms. Durant. The Customs Service was also very pleased to
hear this. We believe that this will, while we might miss one
in the x-ray once and a while, our inspectors are very astute
using the x-ray and other factors, packaging and some
intelligence on occasion in the sort. For us administratively,
this is a giant leap forward because we can then simply
redeliver the mail to the Post Office and say return it. We do
not today have the authority to refuse admission. So this would
give us that ability. I think it would make a very big
difference.
Mr. Greenwood. Do we need, either for Customs or for the
FDA, do you need a change in the law to do this or just a
change in the policy within the Food and Drug Administration?
Mr. Hubbard. Well we have examined that, Mr. Chairman. We
believe we might be able to do this by regulation. We actually
have the authority now to stop this material. But as I said
earlier, we have to go through these notice requirements that
are so burdensome with the numbers and small staff we have,
that it makes it, as a practical matter, impossible.
We think the better thing to do though would be to come to
the Congress and get explicit authority to eliminate that
notice, obviously just for these sorts of things, not for all
shipments of things. Obviously commercial shipments of drugs
and that sort of thing would continue under the existing
regime.
Mr. Greenwood. Well, it seems to me that--and you and I
have had this conversation informally--but it seems to me that
what we have here is we have this firehose of drugs coming
across the border and coming in through the mail. In part, we
have it because the policies that have been in place, and the
border policies that have been in place at the airports has
been relatively permissive. It has been it's too much to handle
kind of an approach.
It seems to me that if we take a zero, essentially zero
tolerance, that what is going to happen is the people who are
ordering these drugs are going to find that they never show up.
Just as they found out through word of mouth, through the
Internet, through Internet chatrooms that we have looked at
some of the conversation that goes on in Internet chatrooms
about how to get these drugs, just as they learned how to get
them illicitly, they will begin to learn that the party is
over, that they are not going to come in any more, and that
they are going to waste their money.
When somebody uses a credit card or other means to pay for
a drug that never arrives, one would assume that they would
stop doing that, that their friends would stop doing that, that
their associates would stop doing that. Eventually, these
illicit facilities, both in Mexico, physical facilities and the
cyber facilities, the websites that access drugs in other
continents, would eventually go out of business for lack of
demand.
So I am delighted to hear that this is going to be the
recommendation. You can be assured that this Member of
Congress, and I think the others on the panel, will support
that recommendation to the Secretary, and that we will be more
than happy to pass the legislation that is necessary in case
there is any question with regard to your authority in this
matter.
The Chair yields back the balance of his time, and
recognizes Mr. Dingell for 5 minutes for inquiry.
Mr. Dingell. Mr. Chairman, thank you for your courtesy.
Ms. Durant, two questions. A simple yes or no answer I
think will suffice. In your Carson City project, in 4 or 5
weeks Custom inspectors could have stopped approximately 16,000
parcels containing pharmaceuticals or something that appeared
to be a pharmaceutical. Is that correct?
Ms. Durant. That is correct.
Mr. Dingell. It is also true that FDA could process only a
tiny fraction of these, approximately 30 a day? Is that right?
Ms. Durant. That is also correct.
Mr. Dingell. So they could only then have reviewed a minute
portion of this?
Ms. Durant. That is correct.
Mr. Dingell. Now this to Food and Drug: That was because of
lack of attention, lack of personnel, lack of money, or why?
Mr. Hubbard. It is clearly lack of staff. We have 150
inspectors around the country to do import work, Mr. Chairman.
We do not have the resources to look at these small packages.
Mr. Dingell. Thank you.
Now, Ms. Durant, FDA could not handle this volume and
Customs was forced to release about 14,000 parcels to customers
without any formal FDA review. Is that right?
Ms. Durant. Yes, sir.
Mr. Dingell. That could have been controlled substances,
Category 1 substances, which are absolutely forbidden either to
manufacture, possess, or sell. Is that right?
Ms. Durant. We have authority to make some seizures on our
own authority.
Mr. Dingell. But I am talking about the 14,000 that you
released. That could have been anything?
Ms. Durant. They were not all reviewed, then it could have
been anything, yes, sir.
Mr. Dingell. It could have been almost anything.
Now, Ms. Durant, FDA has written guidance to Customs that
says as follows, ``It is expected that a Customs Officer from
the Customs Mail Division will examine a parcel and will set it
aside if it appears to contain a drug, biological or device.
Reality in the field: A small number of pharmaceuticals are
referred to FDA by Customs and by the two IMBs. For the most
part, if the parcel doesn't contain a scheduled substance, it
is released back to the Postal Service for delivery.'' Is that
right?
Ms. Durant. Yes, sir.
Mr. Dingell. That is a major contributor, if it not, to the
situation that we confront?
Ms. Durant. Yes.
Mr. Dingell. Because Customs has to do the work, gets no
examination or scrutiny by FDA, and almost anything can get by
this rather curious kind of net. Is that right?
Ms. Durant. It is an overwhelming challenge, yes.
Mr. Dingell. Now, is it my understanding that currently we
have 13 mail facilities across the country that process
international mail? Is that correct?
Ms. Durant. Yes, sir.
Mr. Dingell. Now I would note that most major cities have
such facilities in it, New York, Dallas, Miami, Washington,
D.C.
Now, Ms. Durant, isn't it the case that similar to what we
are experiencing in the Los Angeles facility, these other mail
branch facilities are being overwhelmed?
Ms. Durant. It is generally correct. The degree of being
overwhelmed depends on the source country of the packages to
those facilities, but that is generally correct.
Mr. Dingell. And we must infer that this overwhelming is
leading to a substantial risk of unsafe, counterfeit, or
prohibited substances that should not be permitted in under the
law. Is that right?
Ms. Durant. Yes, sir.
Mr. Dingell. Does Food and Drug deny this?
Mr. Hubbard. Yes, Mr. Chairman. We see a huge diversity of
every sort of drug you can imagine that's coming in these
packages.
Mr. Dingell. Thank you.
Now, Ms. Durant, isn't it the case that before the recent
visit to the Dulles mail facility 2 weeks ago, in just 4 hours
your inspectors found 160 parcels containing pharmaceuticals?
Ms. Durant. Yes, sir.
Mr. Dingell. Now isn't it true also that your agency is
finding on a regular basis pharmaceutical products that are
being shipped into this country that are expired, shipped in
plastic bags with no labels or instructions as to their use, or
pharmaceuticals that your agents can't even identify as FDA-
approved products? Is that right?
Ms. Durant. That is correct.
Mr. Dingell. So this question to FDA. On these matters, you
have no way of knowing whether these substances coming in meet
the requirements that the United States has with regard to
safety or efficacy of prescription pharmaceuticals. Indeed, you
have no way of knowing whether they have been manufactured
using good manufacturing practices?
Mr. Hubbard. I would go even further, Mr. Dingell, and say
they probably do not. Here is one particular package from
Thailand. We spent a week with some of the best drug data in
the world trying to find out what that is. There are three
types of pills in here that we cannot determine what these
pills are.
Mr. Dingell. Was it addressed to a drug cartel member?
Mr. Hubbard. No. It was addressed to a citizen in Northern
Virginia, to the best of my knowledge.
Mr. Dingell. Now, Ms. Durant, it is also the case your
agency are seeing schedule I drugs, such as Ecstacy being
blister wrapped and being sent into the United States through
the mail. Is that not true?
Ms. Durant. That is true.
Mr. Dingell. Let me go over some of the findings you made
regarding Operation Safeguard, and see if I understand them.
There's one point that I want to address particularly. Not even
a single parcel that you received in this met all of FDA's
criteria for importation of prescription drugs. Is that so?
Ms. Durant. That is so.
Mr. Dingell. Not a single one?
Ms. Durant. Not a single one.
Mr. Dingell. Isn't it the case, Mr. Hubbard, that many of
the thousands of the products being shipped into the United
States are from unknown origins, that they pose considerable
risks to consumers because they may be counterfeit, expired,
super-potent, sub-potent, simply tainted, or mislabeled so as
to constitute something other than what appears to be, possibly
even including Schedule I substances?
Mr. Hubbard. I think it is highly likely that is correct.
Perhaps certainly correct.
Mr. Dingell. Now, Ms. Durant, in the Los Angeles project,
your agents had to send thousands of parcels to consumers
because the system that the FDA and Customs relied on cannot
handle the volume that you were now seeing. Is that right?
Ms. Durant. That is correct.
Mr. Dingell. Ms. Durant, has the United States Customs
asked for guidance from FDA?
Ms. Durant. Yes, sir. We have.
Mr. Dingell. What has happened as a result? Have you
received guidance?
Ms. Durant. We have not received all of the guidance that
we need to be effective in this area. However, we have been
working together to come to practical guidance. This
announcement today is very good news for us.
Mr. Dingell. It is very clear, however, that the guidance
that you have up until now is not adequate to address the
problem. Is that not so?
Ms. Durant. That is so.
Mr. Dingell. Mr. Hubbard, isn't it the case that a U.S.
citizen cannot walk into a pharmacy and purchase a controlled
substance such as Darvon, Percocet, or Valium without a
prescription, because these drugs pose inherent risks of
addiction?
Mr. Hubbard. That is correct.
Mr. Dingell. All right. But, however, they can do the same
thing in Mexico, purchase these very same drugs legally and
bring them back into the United States as long as they are
declared to U.S. Customs and have less than 50 tablets per
drug. Is that right?
Mr. Hubbard. I understand that is correct, that they can
purchase it in Mexico. I will defer to DEA on the bringing back
part.
Mr. Dingell. Does anybody wish to deny that statement?
Well, then we will let that stand for the record.
Now to all witnesses, do any of you have evidence that
Oxycontin is available in Mexico? Is it being brought into the
United States under the 50 dosage unit policy?
Do any of you have evidence that Oxycontin is available in
Mexico and is being brought into the U.S. under the 50 dosage
unit policy? That question to all members of the panel.
Ms. Nagel. If I could try to address it. We have received
information that Oxycontin is being smuggled.
Mr. Greenwood. Ms. Nagel, will you flip on your microphone?
Ms. Nagel. Thank you. Excuse me. We have information
specifically from Virginia that Oxycontin is smuggled in large
quantities. We have no specific information about the 50-
dosage-unit exemption being used to specifically bring in
Oxycontin in any kind of organized manner.
Mr. Dingell. Can you deny that Oxycontin is coming in
through the 50-dosage exemption?
Ms. Nagel. I have no specific information other than that
individual, sir.
Mr. Dingell. Now you are with DEA, are you not?
Ms. Nagel. Yes, sir. I am.
Mr. Dingell. And DEA doesn't know then whether Oxycontin is
coming in or not. Is that right?
Ms. Nagel. I said it is coming in, but whether it is coming
in in any organized group, we have one case that we are aware
of.
Mr. Dingell. But you don't know whether it is coming in
under the 50-unit exemption?
Ms. Nagel. If it is, sir, it is coming in individual-by-
individual case.
Mr. Dingell. Okay. Can you deny that it is coming in?
Ms. Nagel. No, sir.
Mr. Dingell. Is there any reason to believe that it could
not come in under this 50-unit exemption?
Ms. Nagel. It would come in under the 50-unit exemption if
the individual met all the requirements of the exemption.
Mr. Dingell. If the exemption is not enforced, he comes in
and shows 50 units, and walks through the Customs checkpoint.
Is that right?
Ms. Nagel. It is my understanding that can happen.
Mr. Dingell. You say it could happen.
Ms. Nagel. Yes, sir.
Mr. Dingell. Is there any reason to believe that it has not
happened?
Ms. Nagel. No, sir.
Mr. Dingell. Does the Customs have any evidence or comments
on this particular point?
Ms. Durant. We do have evidence that it is coming in under
the 50 dosage units.
Mr. Dingell. Under the 50 dosage unit?
Ms. Durant. Yes.
Mr. Dingell. Have you communicated that to DEA?
Ms. Durant. We are gathering the data now.
Mr. Dingell. You are gathering the data now.
Just quickly, perhaps the DEA can inform us. What is this
Oxycontin? It is a very, very powerful substance, is it not?
Ms. Nagel. Yes, sir. It is.
Mr. Dingell. It is absolutely banned for sale or marketing
in the United States. It is Schedule I, is it not?
Ms. Nagel. No, sir. It is not. It is a Schedule II.
Mr. Dingell. It's a Schedule II?
Ms. Nagel. It is a legitimately manufactured pain
medication. It is Oxycodone. It is a long-term release
formulation that allows you to take it every 12 hours instead
of having to take your pain medication every 4 or 3 hours. It
is a Schedule II, sir, and it is legitimately manufactured and
prescribed in this country.
Mr. Dingell. And it is highly addictive, is it not?
Ms. Nagel. Yes, sir. It can be highly addictive if misused.
Mr. Dingell. I think my time has expired, Mr. Chairman. I
thank you for your courtesy to me.
Mr. Greenwood. The Chair thanks the gentleman.
The Chair would note, Mr. Hubbard, that those of us who
have served on this committee for more than 6 years still
affectionately refer to Mr. Dingell as the Chairman, but we do
not encourage our witnesses to do so.
Mr. Dingell. Mr. Chairman, I would like to just make a
brief observation. I don't care how the witnesses refer to me,
as long as they answer the questions.
Mr. Hubbard. I do apologize to the current chairman. Former
Chairman Dingell was with us for so many years that it is
difficult to--you know, habits do grow.
Mr. Greenwood. After I am here for 20 more years, you will
get used to it.
The Chair recognizes the gentleman, Mr. Whitfield, for
questioning.
Mr. Whitfield. Thank you, Mr. Chairman. I also would like
to say that I was delighted to hear Mr. Hubbard outline his
proposal to Secretary Thompson. With Mr. Greenwood, I certainly
think that would be the most effective way to deal with this
problem, because obviously the authorities do not have the
manpower or the money to be very effective in preventing these
drugs from coming in. So I am delighted that you all are going
to recommend that, have already recommended it, and would like
to reiterate what Mr. Greenwood said, that I know most of the
people on this committee I am sure would look forward to
working with you in implementing that.
On the drug Oxycontin, obviously it is an effective drug,
pain killer, and it is legal when it is manufactured in the
U.S., it is prescribed. I guess from my understanding, most of
the problem relating to Oxycontin appears to be by theft,
robbery, whatever. I mean is it a gigantic problem that it is
coming into the country illegally?
Ms. Nagel. If I could answer your question, sir. Our best
information is that we have illegal prescribing, improper
prescribing, pharmacy thefts, fraudulent prescriptions, doctor
shopping. We do believe that Mexico could in fact be
contributing to our problem.
When we received this information, we took some pretty
aggressive steps. There is a single manufacturer of this
narcotic. We have met with the company. We explained that we
had information. We specifically had one case where people were
smuggling it. As a result of our request, they have agreed to
change the indicia of the drug. The drug that is now going to
be exported to Mexico will appear different. If we then
encounter it on the U.S. territories, I will then have the
evidence and data I need to determine that it is being
reimported.
Additionally, the company stopped shipping the 40
milligrams to Mexico. The 40 milligrams that were in-country in
Mexico were moved from the border pharmacies. They were moved
inland. So at this time, you can get the 10 milligrams and 20
milligrams.
If I am given the evidence and the data to demonstrate that
in fact it is coming back in, I am prepared to meet with the
company and look at some drastic measures. But what I need is
the evidence. So we are hopeful, as everyone is gathering
evidence, we have a national action plan that we have put
forward where we are trying to gather the data and get our arms
around the problem domestically and internationally. As we get
the data and we can support the actions, we are more than
prepared to move forward and take whatever action we can to
limit the diversion and abuse in this country.
Mr. Whitfield. Now is Oxycontin exported to other countries
as well?
Ms. Nagel. Yes, sir. It is.
Mr. Whitfield. Okay. So that is being done legally.
Basically what's happening, once it gets to these other
countries, then it is illegally smuggled back into the U.S. to
be used for purposes other than medicinal purposes?
Ms. Nagel. At this point, we have information about Mexico.
My concern was also that we could in fact experience the same
thing from Canada. So at the same time, I asked the company to
change the indicia of what goes to Canada. Fearing that my land
borders would make me the most susceptible to having it come
back. They are going to do that for me also. So that if I start
to see it on the street, I will be able to identify the source.
I have no information of it coming back from any of the
European countries or anywhere else.
Mr. Burr. Would the gentleman yield?
Mr. Whitfield. Yes, I would yield.
Mr. Burr. For one question. From what you have said, is
Oxycontin only manufactured here?
Ms. Nagel. There is one manufacturer, sir. They have plants
in other places. But it is manufactured by one company.
Mr. Burr. But is the product that you speak of in Canada
actually manufactured in the U.S., sold to Canada?
Ms. Nagel. It used to be manufactured in the U.S. It is now
manufactured in the U.K. It is exported from the U.K. to
Canada. But the company has agreed to change the indicia as it
is made in the U.K. so I can identify it if it comes back from
Canada.
Mr. Burr. Thank you for that clarification.
Mr. Whitfield. Well, I appreciate you going into that
explanation. Of course this is an important drug to a lot of
cancer patients and others. So we certainly don't want to do
anything to make it unavailable to them when it is prescribed
legally in the U.S. But we also want to make sure that we
minimize the illegal use of it. So it sounds like you all are
making progress in that area.
Mr. Chairman, I will yield back the balance of my time.
Mr. Greenwood. The Chair thanks the gentleman, and
recognizes the gentleman from Florida for 5 minutes for
purposes of inquiry.
Mr. Deutsch. Thank you, Mr. Chairman. I want to take a
little bit of a different tack to focus in terms of what we
actually find, because again, having gone out to the Dulles
facility, what is clear is that not everything that is coming
in is a controlled II substance, controlled I substance. In
fact, what appears, when we were there, is the vast majority of
stuff that is coming in is either potentially supplements of
some kind, foreign type supplements, or just homeopathic type
things, or for that matter, prescription drugs, antibiotics,
hypertension medication.
I think that is something that I think in the testimony and
the questions up to this point has not been clear. I mean for
all of us, and we can say it again and again, the volume of
substances coming in is astronomical. I mean we are talking
literally tens, hundreds of thousands, literally millions of
substances coming in.
First, I mean if specifically I guess to Ms. Durant, would
you sort of contradict or would you confirm what I just said in
terms of the volume of the stuff coming in?
Ms. Durant. The volume is astronomical.
Mr. Deutsch. Right. But the types, if you would categorize.
Ms. Durant. The types are--I have looked at the lists of
things in these various operations. The types are mixed. You
are correct. There are some herbal drugs. There are some
cardiovascular medications. But there are also a lot of
steroids and narcotics and painkillers, and those sorts of
things.
Mr. Deutsch. Right. Again, we were only out there for 1
day, although they did prepare for our visit by doing a sort
beforehand. But I think what is important to note is that
again, we are talking about the millions. We really literally
are talking about millions of substances coming in.
I think what was clear from Chairman Dingell's comments and
from the questioning, and I think what really from the
perspective, and again I know this is on C-SPAN as well, and
hopefully they will get some coverage about this, is I don't
think on the prescription drug side if it is an antibiotic or
if it is a hypertension medicine, that someone really is
legitimately looking for the least expensive pharmaceutical. No
one wants to buy something that is going to kill them in that
type of situation.
But I think one of the issues that again, you know it is
hard for you to address, but I will tell you that one of the
perspectives I have is that there are many Americans, millions
of Americans, maybe even tens of millions of Americans who can
not afford prescription drugs, who don't have prescription drug
coverage, and for that matter, don't have medical coverage.
Mr. Hubbard, you made a great comment of your
recommendation to the Secretary in terms of not allowing
anything for anyone unless they have a medical doctor's direct
supervision. Great theory if we have universal coverage. I mean
I hope that you add in your recommendation, obviously I am
being a little bit facetious in this, but that you add that the
administration also support universal healthcare coverage for
all Americans so that all Americans will have the opportunity
to have physicians prescribe them drugs, and then have the
supervision of those physicians for those drugs.
But until we get to that point in time, that is not
America. I mean that is not America. I mean America is a
country with literally tens of millions of Americans, working
Americans, who get up in the morning every morning and go to
work and work hard and support their families, do not have let
alone doctor coverage, let alone prescription drug coverage.
So in the real world, and one of the things that we haven't
done enough of, and again looking at the prescriptions and
looking at what is coming in in the tens of thousands, and the
hundreds of thousands of prescription drugs, not Schedule II,
and again I am not discounting the Oxycontin phenomenon, which
is a very, very serious issue. But I would assume that the
percentage of the drugs coming in at that is a relatively small
percentage. Yes, we found steroids. Yes, we found Ecstacy. But
in terms of the volume, if you were there with us, if you spent
time looking at it, it is a small percentage. It might be 5
percent. It might be less of the overall volume. So these are
normal prescriptions.
I guess that is the question that I am saying to you, is
maybe we are looking at this the wrong way. Maybe what we are
really looking at is absolutely that 5 percent is really
significant. All right? But the 95 percent very well might be
hardworking, legitimate Americans who can not afford to go to a
doctor to get a prescription, but are self-medicating. The
answer that you gave is a simple answer, it would stop this
completely. But what do you say to those people that can not
afford going to the doctor, let alone paying a normal
prescription? I mean I am asking you as a question because you
are making that recommendation to the Secretary.
Mr. Hubbard. First, I am sure the Secretary shares your
concern about the availability of prescription drugs to all
Americans. It is virtually impossible to differentiate here,
the diversity is so great. There is every sort of drug coming
in.
The problem is many of them allege to be a perfectly fine,
an allergy drug, in this case. But we don't know that. We do
not know anything about it. All we know is it has a name on it.
We don't know what is in it. You can not test a box of ten
drugs. It costs between $6,000 and $15,000 to do what we call
authenticity testing of drugs. So to have the taxpayer pay to
test that little package would be obviously absurd.
So our fear is that it is an all or nothing thing, that you
can not distinguish between all of these millions of little
packages. There is just no way that we know of. I assure you,
we have spent considerable effort in the last couple of years
trying to assess what these things are and what we might be
able to do to parse out the most dangerous, the less dangerous,
whatever. We just do not know a way.
Mr. Deutsch. Again, I guess, and this is a final question
because I know we are in a vote and my time is up as well. I
mean there is no one who is in that legitimate category that
wants to purchase a drug that does not have the right dosage,
that is a counterfeit drug, that is a misdiagnosed drug, that
is impure in terms of facility. Obviously none of this stuff is
really safe. I mean I think we can all acknowledge that. We
have no oversight of the facility in Thailand. We have no
oversight of the gray market stuff. We have nothing.
One of the things about our system in America is when you
go to a pharmacy you have it. FDA does a great job in terms of
its oversight, in terms of that. There is a safety level
unparalleled in the world, unparalleled in world history in
terms of drugs in the U.S. No one wants to do that.
But I guess one of the things that I think of when I am
looking at this is what is driving people to put themselves at
risk, to put their families at risk, to put their children at
risk. They are not doing it for fun. I mean they are doing it
because they want to save money. There are people out there who
are using the Internet to purchase prescription drugs which
again, the sites are nice looking sites and the description of
my colleague from Michigan very well might be that in Thailand
it is a beautiful website, but it is a rat-infested hellhole
that is producing this stuff in Thailand.
I mean we saw literally dozens of boxes that were clearly
from the same location in Thailand. I mean it was clear that it
just so happened we got a batch of drugs being sent from a
facility in Thailand. We opened them with the Customs
officials, and they were different drugs. They were
prescriptions, prescription drugs that people were clearly
self-medicating.
I guess I mean we would think that a meaningful drug
benefit would deal with this. But I mean that is why I do not
think it is as simple as you are saying. I think that you will
find a lot of opposition in Congress just to ban this across
the board, because in fact there are a great deal of legitimate
people using this avenue, not out of choice, but almost out of
desperation.
Mr. Greenwood. The Chair thanks the gentleman. We could
also solve the universal healthcare problem by allowing auto
body shops to set up surgical centers, but that would be pretty
dangerous too.
We are going to recess now for this vote until 1. We will
reconvene then. We thank the witnesses for their patience.
[Brief recess.]
Mr. Greenwood. The subcommittee will reconvene again. We
thank the witnesses for their forbearance.
The Chair recognizes for 5 minutes for purposes of inquiry
the gentleman, Mr. Burr.
Mr. Burr. I thank the chairman.
Mr. Hubbard, let me say to the FDA I was shocked at what
you told us. I was pleasantly pleased though that the FDA had
taken a very strong position on this, and I want to commend you
and commend the agency because I think the problem is severe. I
think it needed a drastic recommendation.
Let me ask you what the Secretary's response to the
proposal has been so far.
Mr. Hubbard. Well, we talked to him on Monday. I think he
certainly understands the issue. But he wanted to have more
opportunity to talk to us, to understand the risks, to
understand the procedure. I think he feels he needs a little
more information. We will be giving him that, I think very
soon. Of course he will probably want to consult further within
the administration as well.
Mr. Burr. How long will it take us to get some indication
from the Secretary as to whether the agency will adopt this
proposal?
Mr. Hubbard. I can't tell you, Mr. Burr. That is his
prerogative.
Mr. Burr. How urgent on behalf of the FDA does the FDA
think this problem is?
Mr. Hubbard. Well I think by the very fact that we have
characterized the risk here as so great, we would call it
pretty important. The Secretary and his staff, we have already
had discussions with them. They are very attentive to this.
This is not something where they can't find time to think
about.
They do want to have information.
Mr. Burr. Ms. Durant, is the mail that is received at JFK
higher in the number than it is received at Dulles?
Ms. Durant. Yes, sir.
Mr. Burr. How many packages discussed in x-ray at JFK?
Ms. Durant. Twenty to 30 times Dulles.
Mr. Burr. Do you x-ray all the packages at JFK?
Ms. Durant. Not all of them at JFK.
Mr. Burr. What percentage?
Ms. Durant. Ten to 15 percent.
Mr. Burr. Ten to 15 percent?
Ms. Durant. About. I could get a better number for the
record.
Mr. Burr. Let me state that we understand the constraints
that Customs is under. We understand how difficult it is to
operate in a policy that today is so loosely written whether
you are any of the agencies that are up here. But if the
Secretary needs a nudge on the urgency, we have seen the degree
of the problem with just the 10 or 15 percent that we check.
Think about the 85 percent that we are not.
The burden that is placed on Customs today is huge. My hope
is that in that proposal they have got the ability when there
is a drug shipment that comes in, to stamp ``return to
sender,'' and it is over with. It is out of their hands. It
does not need the FDA to send somebody in. It does not need a
letter to go to somebody. We need to eliminate that from the
process so Customs can get to the next piece of the puzzle in
their job responsibility.
Is this proposal, does it include all prescription drugs?
Mr. Hubbard. Yes, it would, Mr. Burr, except for the
exception I mentioned of the compassionate use.
Mr. Burr. Compassionate use.
Mr. Hubbard. Now it would not include at this point the so-
called walk-across folks that go to Canada or Mexico. There, we
would like to think about that some more. There, you have a
face-to-face interaction. The patient actually stands in front
of a pharmacy and purchases a drug, say in Canada. There is an
opportunity because of that to go back if there is a problem
and find the source of the drug. There is an opportunity for
FDA or Customs or others as the patient is coming back across
the border, say the Canadian border, to be warned, to be given
perhaps a slip of paper saying if you have bought drugs, you
need to be----
Mr. Burr. Are they required when they cross in person to
show a prescription for what they----
Mr. Hubbard. I believe they are required to declare, but I
will ask Ms. Durant to answer that.
Ms. Durant. For the 50 dosage units, they are not.
Mr. Burr. They are not, are they?
Ms. Durant. No.
Mr. Burr. In the next panel, panel three, Marvin Shepherd,
the College of Pharmacy, University of Texas, will testify that
he has just been to the border. He has seen Oxycontin packaged
in blister packs, 50 pills, so that it meets the requirements
not to be scrutinized as you cross the border. They are just
sending it across day-in and day-out. I hope that the DEA will
in fact listen to his testimony because it is happening. It
will continue to happen. We won't stop it with that exception
to the proposal that you have in fact made to the Secretary. So
I would ask you to really go back and look at that. We do not
want to just narrow the problem to two borders that we already
have significant problems with.
Let me ask you, would it include over-the-counter products?
Mr. Hubbard. Generally, over-the-counter products like this
are also unapproved. We have given them less attention because
they are viewed generally as safe, but yes, it would.
The theory is that any drug bought in another country that
is unapproved can not be safe.
Mr. Burr. Customs would not have to make a determination?
Mr. Hubbard. That is correct, Mr. Burr.
Mr. Burr. Let me ask you on one other subsection, animal
drugs.
Mr. Hubbard. Animal drugs?
Mr. Burr. Yes, sir. Currently in this country for animals,
we access quite a few drugs from Europe and from Canada. Do you
see animal drugs included under this or do you look at an
exception for that?
Mr. Hubbard. To be honest, we have not had any discussion
about that. I am not aware that that is a problem, but I will
be glad to check that out and get back to you.
Mr. Burr. Granted, animal drugs are not in the volume of
human drugs. But I think when you look at the access that they
need from international markets, it is much greater than the
access that we need for human drugs. But I would ask you to
look at that.
Does Mexico have an equivalent to the FDA?
Mr. Hubbard. Yes, they do. But obviously different
countries have different levels of regulation.
Mr. Burr. Do we have a harmonization agreement with the
approval process with the Mexican agency that is the
equivalent?
Mr. Hubbard. No, we do not.
Mr. Burr. Have we been able to harmonize the standards on
drug approvals with the EU yet?
Mr. Hubbard. We made great progress in a number of areas of
drug testing and development, yes. We are not 100 percent
there, but that is certainly the goal, to make them the same in
both EU and here. The Canadians are involved in that as well.
Mr. Burr. But the reality is that we don't even have the
confidence in their systems that we can interchange the
standards that we use even in the European Union. That is
correct, isn't it?
Mr. Hubbard. That is correct. Although perhaps some day
under the constructs that are being envisioned, that may be
possible.
Mr. Burr. I would like to read just a piece out of your
testimony. I will comment on it and let you comment as well.
``The FDA has not officially permitted the importation of
foreign versions of U.S. approved medications, even if sold
under the same name.'' ``The FDA has not officially permitted
the importation of foreign versions of U.S. approved
medications.'' That one statement right there would say that
the only products that could the under even today's standard
come back in are products that were manufactured in the United
States.
Mr. Hubbard. Or in a foreign plant that was approved and
inspected by the FDA.
Mr. Burr. Well, this says, ``The FDA has not officially
permitted the importation of foreign versions of U.S. approved
medications even if sold under the same name.'' That would be
products manufactured.
Mr. Hubbard. No. I think what that refers to, let's say
Viagra might be made in Pfizer's Irish plant, which is approved
by FDA and it might be made in Pfizer's--I am making up this
example, of course--Spanish plant that is the drug that's sold
in Europe and Asia. We might not have inspected and approved
that plant. So the Irish plant could bring the drug to the
United States and the Spanish plant could not.
Mr. Burr. Let me read one other piece. ``Therefore,
unapproved drugs and reimported approved medications may be
contaminated, sub-potent, super-potent, or counterfeit.'' Given
that that is part of the FDA's testimony today, let me just ask
you one question. How could the FDA sit silent over the past 2
years when the debate of reimportation took place in the
Congress of the United States? When today that is a great
threat in your testimony, reimportation of approved medications
contaminated, sub-potent, super-potent, and counterfeit. How
could the FDA sit silent during that debate?
Mr. Hubbard. I think we have been consistent in expressing
our concern about the safety of these products during the
debate last year about the bill that passed Congress to allow
large shipments, commercial shipments to come in. I do believe,
Mr. Burr, we have been fairly consistent in saying that the
system that Congress created in 1938 serves the public very
well. It is a fairly rigid system. These sorts of drugs from
other countries, whether they are large commercial shipments or
these personal amounts, can not be as easily assured of safety.
Mr. Burr. Given your proposal to the Secretary relevant to
this issue that we are here talking about today, what would the
FDA's position be to this committee if the Congress were
considering reimportation legislation like we saw last year?
Mr. Hubbard. I think we would be saying the same thing to
the committee that we said last year to the various Members of
Congress, which is we are very concerned that a system, if
designed to be a different system than the current system,
poses risks and we can not be assured that we could
successfully implement such a system and bring in safe drugs
because we do not have the same level of confidence about where
it was manufactured, and how it was manufactured, and by whom
it was manufactured, that we have under the current system.
Mr. Burr. Let me suggest if you get asked the question
again, that you give the response of the recommendation that
you made to the Secretary as boldly and forcefully as you said
it. Today we have an unwritten policy for products coming in,
if they meet a certain dose--and you have said there is no way
for us to do this. We need to shut it down. There is no way you
can look at this and say we have got to shut it down, the
problem is so great, and look over here and try to make an
issue of reimportation work.
We can not ask Customs to determine where it was made,
where it came from, how it was stored, whether it is
counterfeit, whether it is adulterated. You know, I said to
some of my colleagues I hoped everybody read the New York Times
article this week about three fake drugs are found in U.S.
pharmacies, hormone drugs, well-known manufactured companies
that their product had been contaminated on the shelf with
counterfeit product. Because of the great work of the FDA and
their ability to track from wholesaler to wholesaler to
wholesaler, I think they have got a pretty good handle on how
this happened. Does it eliminate it again? No.
But the reality is that even the shelves of the pharmacies
that we go to in this country are susceptible to having
contaminated products with the absolute gold standard in the
world as far as drug approval and review.
My hope is that we will not open that system up to the
ability for it to deteriorate with something that sounds good
like reimportation or something that sounds good like personal
use. We ought to always be the compassionate country that has a
compassionate use exception to the standard. But for God's
sake, let us have a standard. I think that is the only hope of
this committee.
Mr. Chairman, I thank you. I yield back.
Mr. Greenwood. The Chair thanks the gentleman, and
recognizes Mr. Stupak. Before doing so, I understand Dr.
Leshner has a pressing need to leave and excuses him from
further testimony.
Mr. Stupak?
Mr. Stupak. Thank you, Mr. Chairman.
In response to Mr. Burr's question, Mr. Hubbard, you
indicated that the FDA is consistently concerned. With all due
respect, consistently you have been doing nothing about this
problem. I'm going back to 1996 when Dr. Shepherd gave you a
copy of his report about these drugs coming across the Mexican
border, and nothing has happened.
We hear from the Rodes today that you go there and you got
their information in July of last year. Again, they have heard
nothing back from the FDA. At least the Customs has agreed to
at least meet with them. Can you make a commitment to the Rodes
you are at least going to meet with them and tell them what is
going on? They lost their son. It is a year later, and you
don't even respond to them?
Mr. Hubbard. I spoke to Reverend Rode before the hearing,
Mr. Stupak, and expressed my condolences, and assured him that
the most vigorous investigation was underway. The question of
feedback to him is not one that I can answer well. These
investigations are kept, for obvious reasons, pretty quiet
because we have to do that.
Mr. Stupak. I am not here asking for an answer. I am saying
at least show the people some respect and get back with them.
You met with their daughter. You took the drugs. They don't
even know what it is. You have done basically nothing. They had
to come here to Washington, D.C. to figure out what you are
doing, if you are doing anything.
Mr. Hubbard. I told, Mr. Stupak, that we have talked to
them and given them some feedback. But I will be glad to
confirm that.
Mr. Stupak. That is not what they are telling us.
Mr. Hubbard. Yes. I understand.
Mr. Greenwood. Would the gentleman yield?
Mr. Stupak. Yes, I would, Mr. Chairman.
Mr. Greenwood. Very briefly. We would appreciate it if FDA
and Customs would arrange--we will arrange for the staff if you
would brief interested members of this subcommittee on the
status of that investigation in a confidential matter. I think
that would be useful. I would like you to take that back to
your offices.
I yield back to the gentleman.
Mr. Stupak. Thank you.
This recommendation you made to Secretary Thompson on
Monday, is that in writing?
Mr. Hubbard. Well, yes. As well as we have met with him and
with his staff more than once. There will be further
discussions.
Mr. Stupak. Will you submit that for this committee?
Mr. Hubbard. I will certainly determine if we can do that,
yes.
Mr. Stupak. How long will it take to make this
recommendation become a reality?
Mr. Hubbard. Well, as I said, if we----
Mr. Stupak. No, no. I want some answers.
Mr. Hubbard. Okay. I hate to say it, but have to throw it
back to Congress because we can't do this.
Mr. Stupak. Throw it back to Congress? You need us to do
it?
Mr. Hubbard. I'm sorry.
Mr. Stupak. Do you need us to do it? Was it quicker for us
to do it or to wait for the Secretary?
Mr. Hubbard. We explained two avenues, Mr. Stupak, to
implement this. One is to write a regulation.
Mr. Stupak. Write a regulation, get it approved, you have
got to publish it in the Register, 180 days comment period. We
are at least a year away, are we not?
Mr. Hubbard. If we do a regulation, that is correct.
Mr. Stupak. And if Congress moves, good grief, it could be
5 years away. Right?
Mr. Hubbard. The only alternative is for us to try to
accept these things now, and I do not think we can do that.
Mr. Stupak. My impatience not only goes back to 1996 Dr.
Shepherd, but I will start here with January 6, 2000, letters
from Commissioner of Customs, letters back and forth not only
from this committee, but from Customs and others, asking you to
address this issue. We get back a lot of nice letters saying we
are concerned, we are consistently going to do something, but
nothing ever happens. I am trying to pin you down to a
timeframe because this can not go on.
In the recommendation you made to the Secretary, the same
recommendation the chairman and the rest of us made to you at
Dulles, the same recommendation we made to you before we went
to Dulles when we had a briefing. We are getting tired of
making recommendations to you. You are the agency, lead agency
who has to take the bull by the horns here, and you are not.
So when I say, with all due respect, consistently doing
nothing, for some of us it is getting a little frustrating.
Mr. Chairman, I move that these letters from Customs and
others back and forth to the FDA on this matter be made part of
the record.
Mr. Greenwood. Without objection, they will.
Mr. Stupak. I also move that Dr. Shepherd's 1996 study to
the FDA and Customs, the rest of it, also be made a part of the
record.
Mr. Greenwood. Without objection.
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Mr. Stupak. Thank you, Mr. Chairman.
So in this recommendation, you have guidelines, do you not,
that says--important guidelines on all prescription drugs--all
of the following criteria need to be met before legal
importation is allowed in this country. Written declaration
affirming personal use, 90-day supply or less of medication,
evidence of medical supervision or prescription, and product
unavailable in the United States. Correct?
Mr. Hubbard. That guidance is limited to unapproved drugs
for serious and life-threatening diseases. It is a tiny number
of drugs.
Mr. Stupak. What percentage of what we are seeing coming
into this country would be taken care of just with the
enforcement of this guideline?
Mr. Hubbard. Enforcement of that guideline would presumably
exclude 99.9 percent.
Mr. Stupak. So why don't we just enforce the guideline that
is on the books?
Mr. Hubbard. Because we have to physically receive the drug
from Customs. I am sorry, Mr. Stupak, but we have to do that.
It is required by the statute.
Mr. Stupak. Mr. Hubbard, we have seen the video. We have
been there. When that parcel comes through the mail and you
look at it, either the Custom agent or yourself or me, if it
doesn't have the written declaration affirming personal use, if
it is more than 90 days, if there is no evidence of medical
supervision or prescription, if the product is available in the
United States, you could automatically reject it without having
to go through all these hurdles that you gave us.
Mr. Hubbard. But understand, Mr. Stupak, we open this
package. It doesn't have those things in it. So the idea is you
send a note to the person and say do you meet the requirements?
Can you demonstrate to us that this is a legal product or you
meet the requirements? Then that person has an opportunity to
come back and explain to the FDA.
Mr. Stupak. Why is the burden on the person who is supposed
to be receiving it, and not on the shipper? If you put the
burden on the shipper, and if 99.9 of them don't meet these
four criteria, why can't you just ship it back?
Mr. Hubbard. Again, I have to fall back on the wording of
our law, which requires us to give notice to the recipient that
we have held the drug and not allowed it to move on to the
recipient.
Mr. Stupak. Same question, just a little different, Ms.
Durant.
You have 13 mail sites. One mail site being Oakland. When
they get this stuff through the mail, they just send it back,
don't they?
Ms. Durant. Yes, sir.
Mr. Stupak. So if one out of 13 sends it back, why can't
all 13 send it back?
Ms. Durant. One of the problems that we have faced is non-
uniformity, which is one of the reasons we have gone to the FDA
for a uniform national standard. We should not be sending it
back, according to the FDA.
Mr. Stupak. But if Oakland is sending it back, is Oakland
doing it right then?
Ms. Durant. No.
Mr. Hubbard. No.
Mr. Stupak. So the other 12 are doing it right, Oakland is
doing it wrong?
Ms. Durant. According to FDA guidelines.
Mr. Stupak. According to their guidelines.
Ms. Durant. To their guidelines.
Mr. Stupak. Has FDA told Oakland that they have got to keep
it all there for them? Have you told them that?
Mr. Hubbard. We have now.
Mr. Stupak. You have now. Since when? This morning or
Monday?
Mr. Hubbard. Just recently we learned of this. There has
been a fair amount of discretion among the districts for this.
Let me explain it. Historically, Mr. Stupak, this was a
small amount of mail. An investigator could look at it and make
some judgments about safety.
Mr. Stupak. Two years ago, we told you this was a small
problem that was growing. Two years ago you did nothing. Last
year we got up to 455 websites. Today we are over a thousand.
We keep telling you, and we keep getting nothing in return.
You are right. It was a small problem with myself, Mr.
Waxman, Mr. Dingell, some of us pointed out 2 years ago. So
see, your small problem has become a big problem. I just for
the love of me can't figure out why your guidelines are not
enforced. If one facility is sending it back, why aren't all 13
sending it back? Then we wouldn't be here. We would not be
having this hearing, and maybe the Rode's young man would still
be with us.
Mr. Hubbard. The Oakland process was not sanctioned by our
folks in headquarters.
Mr. Greenwood. The time of the gentleman has expired.
The Chair recognizes the gentlelady from Colorado for 5
minutes.
Ms. DeGette. Mr. Hubbard, you just told Congressman Stupak
that you had asked Secretary Thompson verbally and in writing
to do this new policy which we are all hopeful could happen,
this policy. Then when Mr. Stupak said can you submit it to
this committee, you said ``I will determine if I can do that.''
What would be the barrier?
Mr. Hubbard. If there is some need for discussion with the
committee about whether this is----
Ms. DeGette. Let me be clear. We would like a copy of the
written request you made to Secretary Thompson for this new
policy. Would that be----
Mr. Hubbard. I will certainly ask Secretary Thompson today
to give it to you, absolutely.
Ms. DeGette. Well you sent it to him, I assume. Didn't you
say you made a request of the Secretary?
Mr. Hubbard. Generally I think we would want the recipient
to concur with that. But we will.
Ms. DeGette. Yes, we would like to have it, if possible.
Thank you.
Now I am glad about this policy about the importation, or
just stopping all of the drugs. I think that is what you are
going to have to do. Unfortunately, I could not go out to
Dulles with my colleagues. I had to go to Denver that day. But
just watching this video and listening to the testimony, I mean
it is a problem that you can't even get your arms around. It
seems to be worsening every day.
So I really think this is an important policy. I agree with
my colleagues, it should be implemented right away. I mean the
agency should work on it. Congress should work on it. We should
all work on it.
Here is the concern I have. I am wondering if you can tell
me how this will work, Mr. Hubbard. You said that you would
stop all of these drugs except for drugs needed for
compassionate care. I am concerned about compassionate care
just like everybody else. But listening to that, I was very
concerned that that could be the exception that overwhelms the
rule.
I will give you an example. How do you know that those
yellow pills you had up there that you can't identify won't be
considered by someone to be for compassionate care? What
standard? I mean it seems to me to be one of those bureaucratic
loopholes through which you are going to let all the drugs come
in.
Mr. Hubbard. I think Mr. Stupak read some of the
requirements of the current policy which would be applicable,
such as that the person have a serious and life-threatening
disease.
Ms. DeGette. Okay. When all of these drugs come in from
overseas, how are you going to apply that policy to them? Won't
you be back in the same box you are in right now?
Mr. Hubbard. We will have to work out a system. Perhaps,
for instance, we could request that any such drugs come in via
the Federal Express process or one of the common carriers, and
have some sort of indicia on it so that Customs knows that this
one has pre-clearance by the FDA. These things can be worked
out.
Ms. DeGette. Well, I am concerned that we are supposed to
have a policy right now, and it seems like that is not working
out. Wouldn't all of the people sending the drugs simply start
putting a statement on there saying ``for compassionate use,''
a declaration.
Mr. Hubbard. What we would do is we would ask the patient
to go to our physicians at our drug center and say I want to go
get this drug from a foreign country. It is unapproved. I have
this condition. May I do so? It is what we call an IND.
Ms. DeGette. How are you going to separate that out from
all of the rest of the drugs coming in?
Mr. Hubbard. Then a thing that had that permission could
have some sort of a note from FDA or indicia or something. We
can work that out and make sure that that doesn't get
intercepted.
Ms. DeGette. My recommendation would be that that would be
as narrowly drawn and easily identifiable by the Customs agents
as possible.
Mr. Hubbard. Of course.
Ms. DeGette. Ms. Nagel, I am wondering if you can comment
on whether you think a policy like that could be practicably
enforced as all of these drugs are coming in.
Ms. Nagel. I think that if we have something in advance,
something that is easily recognizable, there will be attempts
to evade it. There are always attempts to evade whatever
enforcement sort of action we have. But I do believe that
having the ability to free up our resources on the ones where
we are supposed to hold them but we can't----
Ms. DeGette. Right. So you think it could actually help
improve your job.
Ms. Nagel. I think it will help, absolutely.
Ms. DeGette. Okay. Now, Sergeant Gibbs, I wanted to ask you
about something. I want to ask Ms. Nagel as well. A lot of
folks have talked about these pharmacies in Mexico. You can
just walk in and buy anything. I have a constituent who just
came in to see me. He has this horror story that none of us
ever want to live through as a parent. His kid went down to
Mexico. The roommate said just go into a pharmacy and buy this
controlled substance for me, and it is legal in Mexico, so no
problem.
So the kid walked into the pharmacy, bought the controlled
substance, no problem. Walked out of the pharmacy, and was
immediately arrested by the Mexican authorities in a sting
operation, and to this day is still sitting in a Mexican jail.
My question to you, I mean there are a whole lot of
disturbing ramifications to this story. One is these poor
American college students who don't seem to understand the
repercussions. We keep hearing though that these are basically
sources for free flow of drugs across the border. I am
wondering what the enforcement efforts of the Mexican
government have been, and if there is some way we can enter
into some kind of international agreement to get these
pharmacies shut down, or at least to have improved enforcement?
Mr. Gibbs. When I was in Tijuana in April, the
proliferation of the pharmacies are all over the border. There
were policemen, uniformed officers outside these pharmacies. I
saw no one questioned. I saw no one apprehended by these
officers. I really don't know what undercover operations are
taking place.
I went into one pharmacy and said, ``Could I have some
Oxycontin, please?'' He hesitated. He looked me up and down for
a minute and said, ``No.'' I guess I looked like a cop. But
there was a guy behind me, walked into a little shop that was
selling handbags. He asked the proprietor for MS Contin. That
man said, ``It is in the back.'' So he went in the back.
Ms. DeGette. So the story that my constituent tells me
would be an anomaly in your experience?
Mr. Gibbs. I couldn't answer that question. I don't know.
Ms. DeGette. Ms. Nagel, maybe you can.
Ms. Nagel. The Mexican government, like our government, is
taking under the new president, some very affirmative actions.
We are actually fairly optimistic that we can see more
cooperation in this area. There are circumstances where they
have specifically targeted the pharmacies that they believe are
just giving out controlled substances without any legitimate
need. They are also, as we are, trying to stem the flow of
illegal drugs.
The one point that I would like to make, if I could address
something Mr. Burr made, the information that we have received
about the Oxy coming over in the recent surveys are specific to
three different people. My best recollection was each one was
listed as having had a prescription.
So under those circumstances, they would not have been
brought in under the 50-dosage unit exemption. They would have
in fact then come in under a prescription. So there is a lot of
confusion as to when something comes in, when it is in a policy
and not in a policy. I think that is where we and the Customs
Service are working diligently to provide clear guidance to the
inspectors for someone who has a valid prescription can obtain
it, and in fact come back. Those that do not will be
scrutinized, so that they don't believe they can go over and
get anything they want on a day trip and come back with it.
Mr. Greenwood. The time of the gentlelady has expired.
I just would ask one question of Ms. Nagel about Oxycontin
also. Just as an illustration of how addictive this drug is and
what a problem it is, we had Sergeant Gibbs talk about 50
deaths in Virginia. In my district, Bucks County, Pennsylvania,
outside of Philadelphia, we had a physician arrested. He had
written 1,200 prescriptions for Oxycontin and Xanax in a 4-
month period. He was writing them for children as young as 15
years of age. I am reading from the Philadelphia Inquirer.
Investigators said they visited his office at such-and-such
an address several times, observing male and female patients
crowding a waiting room for hours to get prescriptions for the
medications, paying $59, $66 in cash for office visits that
usually involve no examinations. Most of the patients were
gaunt. Their eyes were dilated, and their faces were sunken,
like they were on drugs, and irritable as if they were going
through withdrawal. So imagine one physician's office in my
little neck of the woods. This is a gigantic problem.
You mentioned in one of your statements that if you had
evidence of this stuff coming across the border in significant
measures from Mexico, that the DEA was prepared to take drastic
action. Can you tell us what you mean by that?
Ms. Nagel. I have spoken to the company. I have discussed
with them if we get the evidence that in fact it is coming
back, it is being reimported, I can request that they stop
shipping it to Mexico. To do that, I need the evidence. I also
think it is important, sir, that I address with you I share
your concerns.
Before taking this job, I had the State of West Virginia as
one of my areas of responsibility. It is one of the States that
is seeing the most wide abuse of Oxycontin. As a result, DEA
has done something we have never done before. We have created
an action plan on a specific narcotic drug. It is not on a
class of drugs. It is not on Oxycodone. It is on Oxycontin, the
drug itself.
DEA Chief of Operations has signed it. We are actively
engaged in trying to determine, through enforcement and
intelligence, regulatory administration, industry cooperation,
awareness and outreach, we are literally trying to find out
exactly what the extent of the problem is. It is huge, because
the information we are getting from the narcotic treatment
programs is frightening. It is absolutely frightening that they
are being overwhelmed with their patients being addicted to
Oxycontin.
So please do not ever think that I tried to belittle or
minimize the dangers from Oxycontin, because that was not my
intention. But what I need is evidence. I need to take steps
based on facts and evidence. The agency is more than ready to
do that.
Mr. Greenwood. If I may, I had no intentions of minimizing
your concern about this, but what I do want to know is what do
you mean by needing evidence? What evidence do you need? It
seems like it wouldn't be very difficult to find. Sergeant
Gibbs walks down informally and found a lot of evidence. A lot
of staff have gone down and seen plenty of evidence of
Oxycontin coming across the border. What do you need?
Ms. Nagel. Well, so far I have the one case that I am aware
of from Virginia that caused us to ask the company to change
the indicia, to stop shipping the 40's, to move the 40's in. I
think that was a reasonable action as a result of one
investigation.
We have also gotten anecdotal information from the Customs
Service and other people that they are seeing it come over.
Short of Dr. Shepherd's recent study that showed me three
instances of it coming over, that is what I have. I need to
know exactly how much is coming over. The Customs Service has
assured me they are going to provide that kind of information.
I have gone to my country attache in Mexico. I have asked
him for specific information on abuse and diversion within the
country. I have gone to my diversion investigators, and to my
intelligence people in the agency. I have asked them to get me
comprehensive information on the abuse and diversion within
country, and what they perceive is coming back.
As a result of that, if I get something that candidly is
reasonable, I can then go to the company and first ask them. I
believe they will voluntarily do so.
Mr. Greenwood. This is some language that we picked up on a
chat center from someone who says, hydrocodone, Oxycodone,
morphine are all available in Mexico. It says the key here is
to make a project out of it. Look around. Ask questions of the
pharmacist. What doctor would he recommend for chronic back
pain, headache, tooth pain, et cetera. It says I am looking
right now at three boxes of 40-milligram Oxycontin I obtained
from a medium-sized pharmacy after getting the ``in'' with a
local doctor. So a lot of other stuff in the backroom, morphine
being one of them.
So it seems like the evidence is overwhelming. I am not
going to press you any further on it. But it wouldn't seem to
us that it would take very long to get the evidence that you
need to take the drastic actions that you have taken. It is not
dramatic to say that lives are in the balance on a daily basis
over this one drug.
Let me just ask you this question. If you have an action
plan for this one drug, and that is impressive and that is
appropriate, can that action plan not include zero tolerance
for Oxycontin coming across the border in any number at all?
Ms. Nagel. To do zero tolerance, sir, again, there are
people who have a legitimate medical need to have this drug.
To say that everybody coming over the border does not have
a legitimate medical need is not appropriate. What we need to
do is take the laws as written and enforce them, and to ask
people why you need it, why you're coming over and what is the
legitimate need for the drug. Once that's done people that are
trying to subvert it or someone on their roller skates isn't
going to be permitted to bring in 50 dosage units and that's
what we're working with the Customs Service on is trying to say
here's the law, here's the policy, here's the guidance, ask the
questions----
Mr. Greenwood. Let me ask this. Do you have any evidence of
Americans who have legitimate prescription for Oxycontin going
to Mexico, buying 50 doses or fewer of Oxycontin and coming
back and taking that medication as per their doctor's orders?
Ms. Nagel. I have no specific information, no sir.
Mr. Greenwood. Okay, so in a perfect world we might behave
in one way, but in the real world we've got, it seems to me,
tons of evidence of Oxycontin killing people, being abused on a
daily basis all over this country and coming across the Mexican
border by the truckload and no evidence of legitimate use of
Oxycontin and a decision has to be made using good judgment. I
hope and expected that you'll do that and you'll do that very
soon.
We would also like you to submit a copy of that action plan
to the committee for our record. I thank the witnesses for this
Panel again.
Mr. Burr. Mr. Chairman?
Mr. Greenwood. Oh, Mr. Burr has another question.
Mr. Burr. If I can be recognized for 1 minute.
Mr. Greenwood. Without objection.
Mr. Burr. Ms. Nagel, you said that what you wanted to do
was follow the law. The scenario that you described to us of
product manufactured here, sent to Mexico was brought back into
the country. You do understand that that is against U.S. law
today?
Ms. Nagel. If it is smuggled back into this country, sir,
it absolutely is against the law.
Mr. Burr. The reimportation of any drug manufactured in
this country, based upon U.S. code is against the law.
Ms. Nagel. Sir, if the individual is bringing it back into
this country for legitimate personal use, my understanding is,
sir, that is legal.
Mr. Burr. And I would ask you to meet with Justice, get
them to interpret the patent protection that exists in U.S.
Code that does not permit the reimportation of pharmaceuticals.
Ms. Nagel. Yes sir, I'd be happy to.
Mr. Burr. Because I think that if we look at that, the
patent protection laws trump everything right now until we
change that. We had this discussion with Customs officials last
year. It is impossible to expect that Customs can sit at the
border and determine whether that product was manufactured here
or manufactured anywhere. Members of this committee have looked
at the pills that have come out of China, that it is impossible
without the expertise of an FDA official to test something and
know whether there's actually an active ingredient in it or
not, but there's one thing that I rest assured have researched
and that is that U.S. code today makes it illegal to reimport
products manufactured in this country. If it happens today,
then we have flatly turned our backs on it and I would ask you
to research that just for your own purposes.
I want to say one precaution to my colleagues and to
everybody here. Oxycontin is used in this country by many
individuals with cancer as a pain relief pharmaceutical. My
understanding is when taken as it's supposed to it is certainly
not as addictive as the crushing and the inhaling that the
sergeant described to us and it is a vital therapy for those
cancer patients. So I don't want everybody to rush out and
demonize this one product because there is a need for it.
Let me also remind you that sometimes just the surroundings
suggest what the problem is. In Tijuana today, it's believed
there are 1,000 pharmacies. Now with a population of 1.3
million, that's one pharmacy for every 1300 people.
In San Diego, California there are 125 drug stores. That's
one drug store per 10,800 residents. Just on the surface, I
think we can see that in fact there's every attempt to
circumvent the process and to make sure that the supply exists
to come back into this country.
I thank the Chairman for the time. I yield back.
Mr. Greenwood. The Chair recognizes the gentleman from
Florida ready to inquire. If not, this gentleman from Florida
would be happy to give you some preparatory time.
Mr. Stearns. Yes.
Mr. Greenwood. Okay.
Mr. Stearns. I ask for unanimous consent just for a minute,
just one follow up question.
Ms. Durant, you mentioned, I guess Mr. Hubbard did as well
that the open facility has a different procedure than the other
11 facilities. They're just sending everything back right now,
is that accurate?
Ms. Durant. They're not today. They were sending everything
back.
Mr. Deutsch. For how long was that going on?
Ms. Durant. Over a year.
Mr. Deutsch. We're talking about tens of thousands of
packages that were just going back. I'm just trying to get a
sense.
Ms. Durant. It would be many packages, yes.
Mr. Deutsch. How did they distinguish between supplements
and prescription drugs? What was going on at that facility?
Ms. Durant. There was no distinction. It all went back,
unless it was approved by FDA.
Mr. Deutsch. It's just for 12 months it's going on, were
you getting complaints, was anyone getting complaints that
they're receiving their supplements or anything?
Ms. Durant. No.
Mr. Deutsch. And tens of thousands of packages, no
complaints. Okay, all right, thank you.
Mr. Greenwood. The Chair recognizes the gentleman from
Florida, Mr. Stearns, for 5 minutes.
Mr. Stearns. Thank you, Mr. Chairman. This is a question
that is directed to Ms. Nagel. The DEA personal importation
regulations are important--are, let's see--an importation of
controlled substance for personal use cannot be admitted unless
it is authorized or permitted by the Federal laws and State
laws. Is that true?
Ms. Nagel. Yes sir.
Mr. Stearns. The Food and Drug and Cosmetic Act is a
Federal law that prohibits importation of drugs that are
misbranded, adulterated or unapproved. Controlled substances
from Mexico are misbranded because they have labeling in
Spanish. Controlled substances made in Mexico are unapproved
because they have not been cleared by the FDA. I understand
that both Texas and California laws prohibit importation of
controlled substances. Given the requirement that importation
must be authorized or permitted under Federal and State laws
and the fact that by definition these controlled substances
would not be authorized under either FDA or State law, doesn't
the DEA's current regulation prohibit the personal importation
of controlled substances regardless of the amount?
Ms. Nagel. No sir, when it comes to the personal
importation of controlled substances, both laws apply. There's
no conflict between the Food, Drug and Cosmetic Act and the
CSA. They're both designed to protect the public health and
safety.
In the Controlled Substance Act, Congress explicitly
addressed the personal importation exemption. DEA's regulation
implements that statute. It's only when FDA advised Customs
that the importation of the drug should be disallowed under the
FDCA would the importation be disallowed.
Going to something that Mr. Barr said and I will go back to
the lawyers, it's my understanding----
Mr. Burr. Burr.
Ms. Nagel. Don't tell me I need glasses already. I
apologize. I will have to find out on this specific instance,
but from talking to the lawyers because Congress explicitly
addressed the importation in the Controlled Substance Act and
permitted up to 50 dosage units for legitimate travel with a
variety of things that need to be met, it's my understanding
that the Controlled Substance Act applies. I don't know about
the patent law, sir. I don't know.
Mr. Stearns. Well, staff seems to indicate that this is not
true, that more than a certain amount is under your authority.
Let me just hold for a second because there seems to be a
conflict what staff understands and what you're saying.
[Pause.]
More than 50 doses under the current regulations are
prohibited.
[Pause.]
It does not speak to less than 50 doses. Does that make
sense to you?
Ms. Nagel. If I could try? This is one of the few times in
my life I wish I had a lawyer with me.
Mr. Stearns. Me, too.
Ms. Nagel. If I could try to do this. The way the law is
written to permit international travelers who have a legitimate
need to have medication with them, the law permits you to bring
up to 50 dosage units.
Mr. Stearns. Without any kind of check or anything?
Ms. Nagel. Correct. Without a prescription, without----
Mr. Stearns. Where does it say that? Because a person could
go 50 times with under 50 doses and be able to get these drugs.
Ms. Nagel. The problem is with the implementation of the
policy to enforce the law. The law does not say you can go 10
times a day. That absolutely is not in the spirit of the law.
The spirit of the law is to allow an international traveler
with a bona fide need to bring something back that will get
them home until they can get medical attention. That's not the
way it's been interpreted and it's not being enforced and
that's what we're working with the Customs Service so we don't
have someone coming back on roller skates. But if someone comes
back in without a prescription, they're asked the legitimate
questions and if they don't have the right answers, it does not
come in.
Mr. Stearns. Well, I'm reading from the Controlled
Substances Import and Export Act. Section 1007 and it mentions
the statute in accordance with applicable Federal and State law
they may not import the controlled substance into the United
States in an amount that exceeds 50 dosage units of the
controlled substance.
Now just what that says, it's not saying that it can come
in with less than 50, so you're making a policy decision.
Ms. Nagel. It's not a policy decision, sir. In the law, the
way again I understand it is, it says if I can--a U.S. resident
who enters the United States who does not possess a valid
prescription may not import exceeding 50 dosage units.
Mr. Stearns. And then you assume that somebody could come
in with less than 50, 40?
Ms. Nagel. If, in fact, they can demonstrate the personal
medical necessity, it's in the original container, the trade
and chemical name appears on it, they can demonstrate the valid
need for it, yes. It doesn't mean no questions asked. Anything
comes in, it means if you have a need, you can bring in what
you need to get home.
Mr. Stearns. But in my first question to you I was giving
you the State laws in California and Texas that prohibit
importation of controlled substances, so what you're doing is
preempting State, California and Texas laws?
Ms. Nagel. I wouldn't want to say that, sir, without
talking to my lawyer.
Mr. Stearns. But that's what you're saying by saying that
you interpret this to mean that they can come in with less than
50 doses.
Ms. Nagel. If they meet the requirements of the statute and
the requirements of the regulation and they can demonstrate the
personal necessity, the Controlled Substance Act permits the
entry.
Mr. Stearns. And I think you would agree though that Texas
and California is interpreting this different.
Ms. Nagel. I don't know, sir, and I would be more than
happy to come back with more information, being the only one
who didn't come with a lawyer, once again, that was a major
mistake in judgment.
Mr. Stearns. What staff is contending is that under State
law there is a requirement and it's not interpreted that people
can come in with under 50 doses. So what you're doing by
interpreting that, you're opening it up and a person can come
in 50 times with under 50 doses and do that. What is the number
that the person can do before they are against the law, in your
opinion, 5 times, 10 times, 100 times----
Ms. Nagel. Sir, this is not for someone to be making day
trips. It never was implied----
Mr. Stearns. But you and I both know people make day trips.
Ms. Nagel. That's why we're working with the Customs
Service so that they understand exactly what the policy is,
exactly what the law is, the questions to ask to ensure it's
implemented appropriately and people are not waived into the
country because you have 49 or 50 of 10 different substances.
That's exactly what we're working actively on now.
Mr. Burr. Will the gentleman yield?
Mr. Stearns. Just 1 second. Would you admit that the person
would take more than one trip in a day?
Ms. Nagel. Can a person? Absolutely.
Mr. Stearns. Could they take more than two trips?
Ms. Nagel. Sir, anything is possible.
Mr. Stearns. They could then skirt the law that you just
interpreted this way.
Ms. Nagel. If they were--if they declare it, which is part
of it, they declare it, they talk to the Customs Inspector,
they explain what their personal need is, I don't believe that
drug would be permitted to come into the country.
Mr. Stearns. See, no one keeps track of it. For example, if
I get a prescription under Blue Cross or with my doctor, if I
try to get a prescription for more than let's say, let's say I
get a prescription for 60 days and at the end of 30 days I try
to get another prescription for 60 days, I can't do it because
you can't have too much of this drug. Now in some cases if I
pay for it myself, I can. So the pill instead of being 50 cents
becomes $5, so my point is that the way you've outlined this is
it's sort of a loophole and I think in Texas and California
that they have laws that prohibit the importation of controlled
substances and so I think that's an area that Mr. Chairman, I
think they should clarify and if they don't, Mr. Chairman, they
probably should come back in writing to us.
Ms. Nagel. I'd be happy to, sir.
Mr. Stearns. That would be helpful for us and I yield my
time.
Mr. Burr. I was only going to point out to everybody who's
on the panel. I know each one of you individually thinks you're
very specific on what you've asked Customs to do. In many
cases, there are other laws on the books in the State of
California and in Texas that sort of run opposite, but one of
the things that I've heard from Customs last time they were in,
this time, is that they don't understand what they're supposed
to be doing. Today, you brought specificity to it. My only hope
is that when you leave, we will all push the Secretary to adopt
this. If it needs legislation, legislation; if it needs
regulation, regulation. Let's ram it through as fast as we can.
Let's prove that we can address a problem just like the FDA
approved a leukemia drug in 2\1/2\ months and let's close this
up so we don't have this worry any more. That's the specifics
that we need so that Customs knows how to do their job, so DEA
can confidently address the legal side of it that is so rampant
in every community.
I'd yield back.
Mr. Stearns. Mr. Chairman, I thank you for your courtesy
and I yield back.
Mr. Greenwood. The Chair thanks the gentleman and thanks
the witnesses and would care to remind Mr. Hubbard that
pursuant to Ms. DeGette's request, the committee asks for a
written copy of the recommendation to the Secretary and these
witnesses are excused. Thank you.
The Chair then calls Panel 3, our final Panel to come
forward: Mr. James Christian, Vice President and Head of Global
Corporate Security at Novartis International AG; Dr. Marvin
Shepherd, Professor, College of Pharmacy, University of Texas;
Dr. John Glover, Vice President, Corporate Security, Bristol-
Myers Squibb Company; Mr. Gene Haislip of Leesburg, Virginia;
Mr. Donald deKieffer of deKieffer & Horgan and Mr. William
Trundley, Vice President, Corporate Security and Investigations
at GlaxoSmithKline.
The Chair welcomes the witnesses and thanks them for their
patience for the past 4 hours. You are all aware that this
committee is holding an investigative hearing and when doing so
has had the practice of taking testimony under oath.
Do any of you have objections to taking, giving your
testimony under oath? Seeing no objections, the Chair then
advises that under the rules of the House and the rules of the
committee you are entitled to be advised by counsel. Do you
desire to be advised by counsel during your testimony? In that
case, will you please rise and raise your right hands and I'll
swear you in?
[Witnesses sworn.]
Thank you, you may be seated. You are under oath and we
will begin with Dr. Shepherd. You are recognized, sir, for 5
minutes for your testimony.
TESTIMONY OF MARVIN SHEPHERD, PROFESSOR, COLLEGE OF PHARMACY,
UNIVERSITY OF TEXAS; JOHN D. GLOVER, VICE PRESIDENT, CORPORATE
SECURITY, BRISTOL-MYERS SQUIBB COMPANY; JAMES CHRISTIAN, VICE
PRESIDENT AND HEAD OF GLOBAL CORPORATE SECURITY, NOVARTIS
INTERNATIONAL; WILLIAM TRUNDLEY, VICE PRESIDENT OF CORPORATE
SECURITY INVESTIGATIONS, GLAXOSMITH
KLINE; GENE R. HAISLIP, CONSULTANT; AND DONALD deKIEFFER,
deKIEFFER & HORGAN
Mr. Shepherd. Thank you, Mr. Chairman. I hope to give a
pretty clear testimony and I hope to also clear up some what I
consider false statements being made earlier today. Well, maybe
not false statements, statements that are not true in the State
of Texas or in Mexico, the way I understand it. I hope we can
get some clear air here on what's a prescription and what's
required in Mexico and what's not, get that done.
Let me begin. My name is Marvin Shepherd. I'm from the
University of Texas. I've been interested in this problem of
importation of pharmaceuticals into this country for about 8 to
10 years now. It all came about because of some problems with
U.S. pharmacists when people from Mexico or U.S. residents
would go to Mexico and buy a bag load of drugs and then bring
them in or cross the border and land on to the U.S. pharmacists
and say tell me how to take these and what are they for? And
that's when I first got notice of the wind of the problem
because they didn't have any instructions, everything was
written in Spanish and it was a real problem.
So it's a pleasure to be here and I find it striking that
before the Internet pharmacy operations really no one cared and
everyone seemed to blame the importation of pharmaceuticals a
border problem. Well, I'll tell you right now, it is not a
border problem and the Internet really emphasized that. It was
nota border problem before because in my study in 1995, 40
percent of the drugs purchased out of Nuevo Laredo were going
outside of Texas. They went as far away as Maine, Michigan and
Washington, Virginia, you name it. They went there and that's
41 percent of all males who went down there out of State and 20
percent of all females who went down there and bought drugs in
Mexico our out of the State of Texas. They were not part of the
community. Now admittedly, 60 percent of all the other
purchases down there were from the State of Texas. Sixty
percent of all the purchasers were from the State of Texas down
there. So we faced this problem for a long time and we've been
struggling with the controlled substance incidents and the
problem and we've even prosecuted a lot of people coming across
the border with Ritalin, Valium and Neopercodan and the whole
works.
We've been turned down by Federal courts too, on that.
But I want to reemphasize that I invite any and all of you
to come down to a border town. You won't believe it. Farmacias
are a major tourist attraction in any border town. They're on
every corner, every other street and the major purchaser of the
drugs are U.S. residents. You walk in any of them and you talk
to the owner, the owner will say 95 percent of the people who
purchase drugs here are U.S. residents and that's what they're
made for. It's a huge economy and if we look at the 15 drugs
that I found, the top 15 drugs coming across the border in 1995
were all controlled substances. The volume of those 15 drugs is
$135 million just in 1997. It was 6 percent of the total
Mexican drug distribution right there. Six percent coming out
of a little town called Nuevo Laredo. I don't even want to
think about what's coming out of Juarez or Metamoras or Tijuana
because those have got huge volumes. In Nuevo Laredo, they have
maybe 25,000 to 30,00 walkovers on a Saturday afternoon and
about an estimated anywhere from 25 to 40 percent of those
walkovers are coming back with a pharmaceutical product. So
it's a big business and I feel sorry for U.S. Customs when
they've got two people scanning people who come across and the
line is from here to the parking lot getting back into the
check point. It's impossible to check them all. They're just
lined up and it takes more than an hour sometimes to get
through the border at 5 o'clock on a Saturday afternoon
standing in the hot sun trying to across. It's a huge problem
and it's a big business. Huge business for the Mexican economy.
There are three major reasons and I'll give my opinion as
to why they do this and it's not price is the No. 1. The No. 1
reason why U.S. residents go to Mexico is easy access. Very
easy access to prescription drug products. Mexico has two drug
products, basically, an over-the-counter drug product which
includes antibiotics, all your cardiac medications, all your
cholesterol drugs, all your GI tract drugs, birth control,
estrogen compounds and some steroids. They're over the counter.
As recorded earlier, they sell those like candy and gum. So if
you want tetracycline, erythromycin, ampicillin, Claritin,
Claritin-D, Allegra, you name it, you can get it over there
without a prescription, without anything, just ask for it. Many
of the pharmacies over there will have an American PDR,
Physicians Desk Reference on the counter, along with the
Spanish or Mexican references. Oh, I don't remember the name of
my drug and he'll say well, go over there and find it and I'll
see if I can find the equivalent drug here. Sometimes they're
lucky to find equivalent drug, sometimes they cannot find the
equivalent drug, but they'll find the next best one they can
for that product and they'll say well, by the way, while I'm
here, Aunt So and So needs this and my neighbor or here needs
this and my other friends over there need this and I also need
some tetracycline, hopefully not for their children, but I also
need erythromycin or ampicillin for colds that pop up in my
family. And they purchase it all. That's not talking about the
controlled substance. That's just talking about prescription
drugs.
I want to emphasize one other point for you. I'll bet you
98 percent of those prescription drugs are not FDA approved.
I've got a list of the FDA-approved drugs coming out of Mexico
right now and there's about 12 and most of those are in bulk
form. I don't know if it's the finished product or not. They're
not FDA approved, so what FDA was saying earlier about what's
the quality of these drugs, they don't know. I don't know. No
one knows because they haven't fit the quality standards of
what those prescription drugs look like. So easy access.
If you want to buy a controlled substance and let's clarify
the law for the Congresswoman, if you want to buy a controlled
substance in Mexico, you have to have a prescription from
Mexico. It's got to be written by a doctor in Mexico. The law
in Mexico says and the prescription has to be in duplicate form
because they will keep one copy in the pharmacy. That's the
only thing they really have a record of. They log it into a log
book and there's only three groups of compounds. The No. 1
group are injectables, primarily; the No. 2 group of controlled
substance are most of what we consider IIIs and IVs in this
country, the Valiums, that kind of product, some of the
narcotics, Tylenol 3. The third group are some steroids,
testosterone and some--I've got a list of them here if you want
a list, but those are the three groups. The No. 1, it's pretty
difficult to get a prescription from a community pharmacy, but
it is possible.
Just recently I saw Demerol come across in 50 ampoules last
month and a box of ampoules. Now I don't know if it hits the 50
dosage units or not, but it was a box of Demerol, 50 ampoules
and a box of syringes come across the border.
Now the other drugs, as I said, you need a prescription for
them. Now when you come across you need two prescriptions, a
U.S. doctor, and a Mexican doctor to do it. Now let's get this
clear, and I'll be quite frank and I'll probably get shot
outside this building, but there's a heck of a lot of collusion
going on between the Mexican docs and the pharmacies, a lot of
collusion. You go into them and you won't even see the doc,
you'll see a clerk who writes the prescriptions. I've been
there. I've seen it. Somebody is at the front desk says what do
you need? I said I need Rohypnol, Valium, Asylex, you name it
and they'll write it for you. As a matter of fact, the last
time I was in there he wrote all three of them out on one
prescription and gave it to me. He said I recommend you go to
the international pharmacy two blocks up on the right.
The next Sunday I went in with CNN News. I went to the
pharmacy. I knew the prescription writer was closed. I went
into the pharmacy and I said I'll need Valium. I can't remember
the other three drugs, I needed. I wrote them on a piece of
scrap paper, gave them to a 12-year-old kid. The kid went
upstairs and down the street somewhere, came back with a
prescription written on one prescription form for three drugs.
Then the pharmacist, and it wasn't a pharmacist either, just a
clerk, gave me the prescription and says write your name at the
top of this prescription. $300 later you walk out with them.
But they want documentation? Ritalin was the other drug because
Ritalin is a popular product coming across.
It's easy and you can see the collusion between the docs
are getting their $30 to $50 for the controlled substance and
the pharmacist getting his money up front on the controlled
substance. No directions, no labels, everything is written in
Spanish and no one knows how to take it whether it's a
controlled substance or a non-controlled substance and it's a
huge mill, economic mill for Mexico right now. Huge.
The lower prices. Everybody has talked about the lower
prices. Let's----
Mr. Greenwood. I'm sorry, we are all fascinated and as a
result of that I've been extraordinarily indulgent with the
time.
Mr. Shepherd. I'll close.
Mr. Greenwood. We'll ask you lots of questions, but we need
to go on to the other witnesses.
Mr. Shepherd. Sure. That's fine. Do you want me to close it
or----
Mr. Greenwood. Do you have a concluding paragraph, why
don't you go there and then we'll get back to you with
questions.
Mr. Shepherd. Concluding paragraph. You can enforce
existing law. I tend to agree with a couple of Congressmen
here, the existing law could do the job. I think you need to
harmonize. You need to get a group together with the Mexicans
and the U.S., harmonize the business. Some kind of panel has
got to be put together to look at the problem. No. 3, to stop
the diversion, you could ban controlled substances completely.
We already talked about that one. No. 4, the public education
needs to be done. Most Americans think that if it's made by Eli
Lilly or Squibb or Pfizer, whoever it is, it's FDA approved.
They think anything with that kind of a label is FDA approved.
Even if it was made by Eli Lilly of Mexico City, it's not the
truth. That's a false. It's not true at all. And I think we
need to teach Customs and FDA people the realities of the real
world out there and what's going on.
Customs people cannot make the determination whether it's
medical necessary or not or it's compassion. They can't do
that. They don't have the training for that. I don't know how
they're going to do that and I'll close with that. I'll wish
you the best.
[The prepared statement of Marvin Shepherd follows:]
Prepared Statement of Marv Shepherd, Director, Center for
Pharmacoeconomic Studies, College of Pharmacy, University of Texas
introduction
It is pleasure being here today to discuss the issue of the
importation of pharmaceutical products. I have been involved with this
area for close to a decade, but my involvement has been on the issue of
Mexican prescription drugs entering the U.S. I find it striking that
before internet pharmacy operations, it was difficult to get anyone's
interest and attention with the problems of importation of
pharmaceuticals from Mexico, but now with the growing international
pharmaceutical market via the internet concern for all methods of
pharmaceutical importation has risen. I applaud you for taking on the
task and looking in depth at the issues and problems created by the
importation of pharmaceutical products. There are many social, legal
and medical issues to address, but the main concerns I have involve
patient safety and lack of control. People have been hurt and some have
died due to the importation of pharmaceuticals. Unless we can find a
better method of controlling the problem, more people will suffer.
As mentioned, Texas has faced the problem of drug importation from
Mexico for decades but in the last five to ten years the practice has
escalated. It is estimated that from 25 to 40 percent of all U.S.
residents who enter Mexico bring back prescription pharmaceutical
products. Many people repeatedly visit Mexico to obtain drug products
for themselves, family and friends. It has also been documented that
from one El Paso, Texas clinic serving US residents, over 80 percent of
the patients go to Mexico to obtain their prescription drugs. If you
want a full perspective of the size of this importation industry, I
invite you to visit anyone of the Mexican border towns of Texas. Rows
of farmacias line the streets of Nuevo Laredo, Juarez, Reynosa and
Metamoras. Farmacias are a major tourist draw for the Mexican economy,
especially border town economies.
The customer base for this industry is U.S. residents and it is
huge; it is so huge that U.S. Customs struggles with just handling the
volume of people. How do check 25,000 to 30,000 people who walk across
one bridge and returning the same afternoon? And what about the
vehicular traffic? Over a million vehicles cross and return from Nuevo
Laredo each month. In 1997, over 7 million U.S. residents used the
Laredo border crossing between Mexico and U.S.
The size of the retail pharmacy business enterprise in border
communities is huge. For example, the estimated 1997 annual dollar
volume for just the top 15 pharmaceutical products entering the U.S.
from Nuevo Laredo was $134 million. This is a conservative estimated
because it only assumed 25% of the U.S. residents entering Nuevo Laredo
purchased pharmaceuticals. To get a better perspective, this $134
million makes up nearly 6 percent of the total Mexican pharmaceutical
market and this was just for 15 products from one border city. Another
view is to look at the volume of drugs. Our research documented a
conservative estimated of over 11,000 Valium<SUP>'</SUP> tablets were
coming across from Nuevo Laredo per day by U.S. residents in 1995. I
have do not believe this number has decreased, in fact I tend to think
that it has increased.
Don't be thinking that this is a Texas problem or a California,
Arizona or New Mexico state problem, because my research documents that
41 percent of males and 27 percent of the females who purchased
prescription drugs in Nuevo Laredo were NOT from Texas; we found that
these U.S. residents were from 37 states; some were as far away as
Washington, Maine, Minnesota and Massachusetts. The Mexican
pharmaceutical importation practice has been an ongoing problem and
affects more than just border states and communities.
reasons why people visit mexico for drugs
There are many reasons why U.S. residents visit Mexico to purchase
pharmaceuticals. The main reasons why U.S. residents obtain their
pharmaceuticals from Mexico are:
1.) Easy access to pharmaceuticals,
2.) Lower prices for selected drug products; and
3.) The drug product is not available in the U.S.
Also, farmacias have done well marketing their products to
tourists. They have internet sites, they have put ads in newspapers
papers and there have been many magazine and newspaper articles which
describe the process and document the cost savings. Few of these
articles describe the legal problems nor do they describe the drug
safety problems and risks. Let me take a minute to talk about each of
these reasons.
easy access
Most prescription drug products in Mexico are sold as over-the-
counter products. You can purchase antibiotics, high blood pressure
medications, heart medications, gastrointestinal medications,
antihistamines, birth control pills, plus many other pharmaceutical
products without needing a prescription. These products are sold like
candy bars and gum are sold in the U.S. In fact, if you do not know the
name of the product you want, many of the farmacias will have a U.S.
Physician Desk Reference on the counter for reference. This compendium
list all drugs available in the US. So you can look up the drug you
want and the farmacia clerk will try to find the Mexican drug
equivalent or a similar product. Many times there is no Mexican
equivalent available. Also, please note there are no prescription drug
labels as we have in the U.S. No drug directions for use are given, all
the products are labeled with the manufacturer's label in Spanish.
Controlled drug substances in Mexico do need a prescription written
by a physician practicing in Mexico. However, this requirement is no
barrier to purchasers of controlled substances. Some Mexican physicians
in border towns have established their practice just to provide
prescription for U.S. customers. In fact, they have developed business
relationships with neighboring farmacias.
lower prices
Some Mexican prescription pharmaceuticals do have a lower price
with many have a substantial lower price. However, not all Mexican drug
products have a lower price and for many products the U.S. prices are
very competitive, especially when you compare prices of antibiotic
therapies or generic drug prices. For example, the price of
Dimetapp<SUP>'</SUP> 12 capsules in Juarez Mexico is $16.15 while the
price in the U.S is $6.85. Claritin D<SUP>'</SUP>, 12 capsules in
Juarez is $16.38, in the U.S. it is $19.75. An example, of a major
difference in price of Vasotec<SUP>'</SUP> 10mg in Juarez is $16.24 and
the price in Austin Texas is $47.88. Overall, prices are cheaper in
Mexico, but it is product dependent. The perceived major differences in
prices do draw many people to Mexico to purchase pharmaceutical
products, especially for those people who do not have limited funds
such as those on a fixed income, retired or lack prescription drug
insurance coverage.
products not available in the u.s.
As mentioned, some Mexican pharmaceutical products are NOT
available in the U.S. Either the manufacturer decided not to market the
product or in some cases the product does not have FDA approval.
Examples of Mexican products not available in the U.S. are
Asenlix<SUP>'</SUP> (clobenzorex a stimulant
product),Chloromycetin<SUP>'</SUP> (Chloramphenicol<SUP>'</SUP>,
antibiotic), Ponderex<SUP>'</SUP> (fenfluramine, weight reduction), and
Rohypnol<SUP>'</SUP> (flunitrazepam, sedative hypnotic). Also, some
Mexican products are combination products which are not available in
the U.S. For example, the product Qual<SUP>'</SUP> contains
acetaminophen 200mg, Valium<SUP>'</SUP> 2mg, and Darvon<SUP>'</SUP>
50mg. Except for products banned from the U.S., Customs officials do
allow people to bring into the U.S. pharmaceutical products which are
not available in the U.S. as long as the patient has proper
documentation for using the product. In addition, if people begin a
drug therapy in Mexico, they are allowed to import the continuation of
such therapies to the U.S.
patient safety concerns
As mentioned earlier, I have some grave concerns about patient
safety and the use of Mexican pharmaceuticals. My concerns revolve the
lack of medical supervision of the patient's therapy, the patient's
lack of understanding on how to use the product correctly and the
indiscriminate use of products. Finally, I have a concern about the
assurance of product quality. To me, all of these have a potential to
harm, severely injure or kill people.
First, the vast majority of Mexican drug products are NOT FDA
approved. There are only a handful of products made in Mexico which
have an FDA approval and most of these are bulk products and not
finished goods. Based on this fact alone, the vast majority of people
who enter the U.S. from Mexico with a prescription pharmaceutical
product are in violation of U.S. law. The key point I want to make
here, is that U.S. customers of Mexican pharmaceuticals need to be
informed that foreign made versions of U.S. approved drugs may not have
been manufactured in accordance and pursuant to FDA. In other words,
the products may not be the same.
The health concern I have is when a U.S. resident, who is
successfully being treated and is stabilized on a U.S. manufactured
drug product, goes to Mexico obtains what he/she considers to be the
identical product, but it is not. The potential harm is great depending
on the therapeutic agent and the clinical outcome. Switching back and
forth from U.S. made product to Mexican product may be dangerous,
especially for those products which have a narrow therapeutic index.
My second concern is the indiscriminate use of prescription
products, especially antibiotic products, but other therapeutic agents
are also affected. The indiscriminate and self-medication use of
antibiotics increase the problem of antibiotic resistance. This has
already been documented with the high antibiotic resistance rates for
tuberculosis in Mexican border cities. Some U.S. residents visiting
Mexico purchase tetracycline, penicillin and erythromycin like candy
bars. They save the products and self-treat themselves, family members
and friends. Also, with self-treatment, medication compliance is
usually lower which contributes to the antibiotic resistance problem.
The lack of understanding and the poor use of pharmaceutical products
has the potential of seriously affecting the health of many.
As mentioned earlier, when U.S. customers purchase Mexican drugs
little if any information is given to the customer as to how to use the
product. There are no drug labels giving directions for use and the
labels are written in Spanish which may be of no value to some. Thus,
the opportunity to learn about the Mexican product is limited. This can
be very dangerous for those who want to ``try-out'' a new product.
Final note, few farmacias have a college educated pharmacists on there
staff. In fact, farmacias which do not sell controlled substances are
not required to have a college educated pharmacists on their staffs.
Most farmacias are staffed with clerks, thus limiting the customer's
opportunity to get competent help and information about the medication.
Even if the farmacias does provide controlled drugs, there is no
requirement that a college educated pharmacist must be present. As a
side note, upon returning to the U.S., many Mexican drug purchasers
visit U.S. pharmacists and inquire as to how to use the products
purchased in Mexico.
recommendations
Enforce Existing Law
The recommendation I want to make is to ban the import of all non-
FDA approved pharmaceuticals from foreign countries. Basically, this
recommendation is asking for the enforcement of the current written law
(Federal Food Drug and Cosmetic, 21U.S.C. Section 331). I realize that
this is a difficult political decision, especially with the elderly
contingent and those who do not have the financial resources to
purchase therapeutic remedies. It would also cause international
political problems, especially with Mexico and the NAFTA agreement.
Develop a Strategic Plan to Harmonize Pharmaceutical Business Between
U.S. and Mexico
I believe the major problem between Mexico and U.S. on the
pharmaceutical trade is the vast differences in regulation, education
and professional pharmacy practice. Efforts need to be made to bring
health care practitioners and officials together from both countries
and develop a plan to try to harmonize the medical and pharmaceutical
industries. U.S. residents have been using the Mexican health care
system for decades. However, currently, more U.S. residents are taking
advantage of and abusing the Mexican health care system for personal
gain. Medical and pharmaceutical regulations and practice behaviors
within the border communities need to be examined and perhaps modified
on both sides to better provide patient care. This is a long term
approach and will take a lot of effort, but it is a positive step
forward.
Ban Controlled Substances from Entering the U.S., especially from
Mexico
While waiting for the long term approach in addressing the
professional and regulatory climate between the two countries, my
recommendation would be to try to control the personal import of
controlled substances from Mexico. In my research, it was found that
the most popular drugs coming across the border from Mexico at the
Laredo border crossing were controlled substances. All of the15 most
frequently declared products entering the U.S. were controlled
substances. These included narcotic analgesics (Neopercodan, Nuban
Tylex), tranquilizers (Valium), sedative/hypnotics (Rohypnol, Qual,
Halcion), stimulants (Ritalin, Tenuate Dospan, Diminix, Aselix)
antipsychotic/antianxiety (Antivan), and muscle relaxant (Somalgesic).
What alarmed me the most was that the vast majority of these products
were imported by people under 35 years of age. If you are worried about
the impact such a recommendation would have on the elderly, I can say
that few elderly purchase controlled substances in Mexico. My study
found that only 0.6 percent of all controlled substances entering the
U.S. were carried by someone over 65 years of age.
Although I have not compared the prices of controlled substances
between the U.S. and Mexico, it is my belief that the cost differences
are small, mainly because most controlled substances in the U.S. are
available in generic form. My personal feeling is that much of the
controlled substances entering the U.S. are for recreational use and
sold on the streets, but I have no data to support the belief. I just
question why so many youths travel to Mexico and bring back so many
stimulants, tranquilizers and narcotics. Basically, this recommendation
calls for a cost-benefit analysis. Does the benefit of allowing the
legitimate use of controlled substances from Mexico outweigh the black
market and detrimental and addiction effects of recreational drug use?
Personally, I do not think so.
Last month I spent a Saturday in Laredo assisting the FDA in
collecting data on the type and amount of pharmaceuticals coming across
from Nuevo Laredo. I really did not see many changes, of course I saw
no Rohypnol<SUP>'</SUP>, but I did see tranquilizers
(Valium<SUP>'</SUP>) and narcotic analgesics( Neopercodan<SUP>'</SUP>
and Oxycotin<SUP>'</SUP>) and most of these were being carried by males
in their 20s or 30s.
Develop a Public Educational Program on the Risks Associated with
Foreign Medications
My second recommendation is for the development of a major public
educational program informing the public about the potential problems
which may result with the use of Mexican pharmaceuticals or foreign
made non-approved drug products. Currently, the public believes that
just because a well-known U.S. based pharmaceutical manufacturers label
is on the product the product is FDA approved. Nothing can be further
from the truth. Drug labels in Mexico are similar in size, type, color
and style with the U.S. and when the consumer sees Eli Lilly, Pfizer,
or any other manufacturer's label they assume it is a FDA approved
product. I recommend that a public education program needs to be
developed warning them that this is not always the case.
In this recommended educational program, the threat of counterfeit
medications from Mexico needs to be highlighted. Recent reports have
documented the increasing risk and threat of counterfeit medications
coming into the U.S. from Mexico. The public needs to be aware of the
problem and the potential risk. In my opinion, I think the threat of
counterfeit medications will continue to increase with the high prices
of pharmaceuticals. We need to develop better and cost-effective
surveillance techniques.
Give U.S. Customs and FDA Technological Support
My last recommendation is to provide assistance to US Customs and
the FDA in developing programs to monitor the importation of foreign
drug products. Data are lacking on the extent of pharmaceutical
products are entering the U.S. from Mexico. I have worked with Customs
agents in Laredo and they are overburdened with this problem. The
number of people crossing the border is tremendous. In fact, in my
opinion they are begging for assistance. They lack the pharmaceutical
training, and expertise to identify potentially hazardous prescription
drug products. In addition, they lack sophisticated computer technology
to collect the needed data to properly monitor the extent of drug
importation. They are still using the handwritten form method. New
computerized methods need to developed to improve the efficiency and
effectiveness of their enforcement for prescription drug products.
closing
Thanks for asking my input. I'll be glad to work with you and other
governmental officials to explore our opportunities to assure quality
care and patient safety on the procuring and use of pharmaceutical
products. Thanks for this opportunity.
Mr. Greenwood. Thank you very much.
Dr. Glover for 5 minutes, please.
TESTIMONY OF JOHN D. GLOVER
Mr. Glover. Thank you very much, Mr. Chairman and committee
members. My name is John Glover. I'm Vice President for
Corporate Security for Bristol-Myers Squibb Company, a
worldwide medical and health care pharmaceutical company doing
business in over 100 countries. I have submitted a written
report for the record, but I'll just make a few brief remarks
at this time.
Before I became Vice President for Corporate Security with
Bristol-Myers Squibb Company, I had a 24 year career in the
FBI, an investigative, administrative and executive positions.
My last position in the FBI, I was Executive Assistant
Director, one of three positions reporting to the Director.
Also, while I was in the FBI I was assigned to the Atlanta FBI
Office. During the early 1980's we conducted an investigation
of pharmaceutical sample abuse. That particular case we called
in Atlanta at the time our farmity case, among other factors,
led to hearings on the Hill and the enactment of the
Prescription Drug Marketing Act. I have always believed in the
strict controls and the flow of prescription drugs are
essential to protecting the health and safety of Americans.
Concerns about the risk to public safety from adulterated and
counterfeit imported medicines, I can tell you, were paramount
in the minds of the legislators at the time of the enactment of
the PDMA. In my opinion, concerns for the public health and
safety of American citizens should continue to be paramount in
the minds of this legislature and in any legislation passed by
any Congress. I will only make a few points.
Point number 1 that counterfeiting of prescription drugs is
a global and growing problem; that pharmacies, distributors and
criminal enterprises in Mexico and I agree with Dr. Shepherd
are significant sources of the counterfeit and diverted
medicines that we find on U.S. shelves and in U.S. medicine
cabinets; that factories in India and China are the sources of
most of the bulk actives used in counterfeit pharmaceuticals
worldwide; that improved technology and the Internet have
contributed to the expansion of this trade in counterfeit
pharmaceuticals and I also agree that from my experiences that
the FDA, the DEA and the Customs Service lacked the resources
necessary to police effectively for counterfeit and diverted
pharmaceuticals.
As a Security Vice President with Bristol-Myers Squibb
Company we formed a group several years ago called the
Pharmaceutical Security Institute. The Pharmaceutical Security
Institute is an industry body whose primary purpose it is to
conduct investigations worldwide primarily addressing the
international counterfeiting problem in pharmaceuticals and
we've conducted numerous studies and investigations. We've
conducted studies in China, studies or investigations in China
and India and the Philippines, in Indonesia and South Africa,
Europe, South America, Mexico. Each of our studies or
investigations have resulted in the findings of the existence
of counterfeit and diverted problems in those locations.
So I want to say that there's a major problem of
counterfeited and diverted problems out there. What can we and
should we be doing to ensure that the problem of worldwide
counterfeit and diverted problems did not become a significant
U.S. problem. First, we must recognize that the U.S. is the
largest and most lucrative market in the world, is the ultimate
target, the ultimate target for many counterfeiters and
diverters. We must do what we can to make sure that we don't
make it easier for these counterfeiting operations than we
already have. Therefore, we should continue to maintain our
political will and not allow the desire for low cost medicines
to undermine our commitment to protecting the health of U.S.
citizens. Second, we must ensure that maintain comprehensive
legislation to protect our pharmaceutical industry and
encourage innovation. Third, we must aggressively enforce the
laws to combat the trade of spurious medicines. And then last,
we must maintain strong penal sanctions against individuals
convicted of violating the various drugs laws.
That's the end of my brief remarks, Mr. Chairman and
committee members. Thank you for the opportunity to express my
view on this important subject.
[The prepared statement of John D. Glover follows:]
Prepared Statement of John D. Glover, Vice President, Corporate
Security, Bristol-Myers Squibb Company
Good morning Mr. Chairman and committee members. My name is John
Glover. I am the Vice President for Corporate Security at the Bristol-
Myers Squibb Company. Bristol-Myers Squibb Company is a pharmaceutical
and related healthcare products company who's mission is to extend and
enhance human life. The company does business in more than 100
countries around the world. I have been in this position for over 12
years. Before coming to Bristol-Myers Squibb, I spent 24 years in the
FBI investigating federal crimes.
I was in charge of the FBI's Atlanta office when it conducted a
major investigation into pharmaceutical sample abuse. The findings from
this investigation were among the factors that led to the Congressional
hearings that resulted in the enactment of the Prescription Drug
Marketing Act. I have always believed that strict controls on the flow
of prescription drugs are essential to protecting the health and safety
of Americans. Concerns about the risk to public safety from adulterated
and counterfeit imported medicines were paramount in the minds of
legislators when they enacted the PDMA. In my opinion, concerns for the
public health and safety of American citizens should continue to be
paramount in the minds of this legislature, and should inform any
legislation passed by this or any Congress.
The key points to my brief remarks today are as follows:
Counterfeiting of prescription drugs is a global problem.
Pharmacies, distributors, and criminal enterprise in Mexico are a
significant source of the counterfeit and diverted medicines on
U.S. shelves and in U.S. medicine cabinets.
Factories in India and China are the sources of most of the bulk active
used in counterfeit pharmaceuticals worldwide.
Improved technology and the internet have contributed to the expansion
of trade in counterfeit pharmaceuticals.
FDA, DEA, and U.S. Customs Service lack the resources to police
effectively for counterfeit and diverted pharmaceuticals.
Counterfeiting of prescription drugs is a global problem.
Counterfeit pharmaceuticals are a global problem. The World Health
Organization (W.H.O.) has estimated that between 5 and 8 percent of the
worldwide trade in pharmaceuticals is counterfeit, and that the problem
is worse in developing nations than in developed nations such as the
United States. the W.H.O. acknowledges that 5 to 8 percent is only an
estimate, since no one has conducted a systematic worldwide study of
the counterfeit medicines problem. Nevertheless, based on my 24 years
of experience with the FBI and my 12 years with Bristol-Myers Squibb, I
am confidant that ``5 to 8 percent'' is, if anything, an underestimate.
Increasingly, the illicit pharmaceutical trade resembles the
worldwide narcotics trade, where product is sourced in one country,
formulated into tablets or capsules in another country, packaged in yet
another country, and then transshipped through other countries to its
final destination.
Numerous dramatic stories of deaths and illness caused by
counterfeits and diverted medicines in various countries such as south
and subSahara Africa, Asia, Europe, and Latin America have been
reported in the media.
A recent example of this nefarious trade was described in Scrip--
World Pharmaceutical News in July 2000. The article reported that
Italian authorities had seized 240,000 packs of counterfeit drug
products in Genoa and Milan, and that the products were worth more than
$1 million. The counterfeit products were from India and China, and
were intended for human and animal use. Italian authorities arrested
ten individuals involved in this organized criminal enterprise.
Separate and apart from news reports, over the past several years,
the pharmaceutical industry has been involved in various studies and
investigations regarding counterfeit medicines.
A pharmaceutical security industry group conducted a 15-month study
in the Philippines during 1994 and 1995. During this period, we
collected 1,359 samples from 473 drugstores. we determined that 8
percent of the samples were counterfeit and that 11 percent of the
drugstores visited were dealing in counterfeit medicines. Fully 17
percent of the medicines obtained were illegally imported or illegally
diverted into the Philippines. The counterfeit medicines included
cardiovascular, rheumatoid arthritis, osteoarthritis, asthma, anti-
infective and anti-inflammatory drugs.
In a similar study in Indonesia, we collected 1,309 drug samples.
While the results were not as conclusive as the Philippines study, one
company reported a significant counterfeit problem with one of their
best selling drugs and a lesser problem with another.
The pharmaceutical security group subsequently conducted a study in
China. We collected 842 drug samples from 262 outlets in 11 cities.
Five different counterfeits of the same products were found. During
this same period, we encountered one state-owned pharmaceutical company
that counterfeited three best-selling drugs from three different
manufacturers and shipped these products to the Philippines and to
Europe. Counterfeiting in china has expanded in scope and
sophistication since that time.
Pharmacies and distributors in Mexico are a significant source of
dangerous counterfeit and diverted medicines on U.S. shelves
and in U.S. medicine cabinets.
The pharmaceutical security institute is a security group
representing the pharmaceutical industry whose primary focus is
addressing the trade in counterfeit medicines. In a 1998 trip to
Tijuana, a Pharmaceutical Security Institute representative visiting a
pharmacy was steered to products which were said to be as ``good as the
originals but at lower prices.'' The packaging would have looked
familiar to a U.S. customer--the labels were in English and the bottles
appeared to be American. Nevertheless, there were significant
differences between these Mexican knock-offs and legitimate U.S.
products. First, there was no guarantee of the quality of the Mexican
knock-offs. There was no way to know whether they had been manufactured
in accordance with good manufacturing principles, or to know the
conditions under which they had been packaged, stored, handled, or
shipped. Indeed, there would have been no way for a consumer to know
the true contents of the bottles. Mexican knock-offs could contain the
proper active ingredient in the wrong amount, or they could contain a
totally different active ingredient than the one listed on the label.
The pills could be superpotent, subpotent, or even toxic. Second, it is
often impossible for a consumer suffering from an adverse reaction to
identify and contact the manufacturer of one of these Mexican knock-off
drugs. The investigator in question was unable to locate one
manufacturer, even when he described an emergency situation.
Unfortunately, there was no company address or phone number on the
label. After several calls, the distributor of the product was located,
but on three successive days, he refused to provide a location of the
manufacturer even when it was mentioned that someone was injured by
their product.
In August of last year, investigators made another visit to
Tijuana. Again the store clerk--who was not the pharmacist--directed
the investigators away from name-brand products to what he called
``generics.'' These products should not be confused with ``generic
drugs'' in the sense that you and I understand the phrase. In the
United States, when a drug loses its patent protection, the Federal
Food, Drug, and Cosmetic Act permits generic manufacturers to market
``generic'' versions of the drug, subject to certain conditions. These
U.S. generic pharmaceuticals must be identical to the name brand
products on which they are based. Also, the manufacturers are subject
to good manufacturing practice regulations. So-called Mexican generics
are not approved in the U.S. and may not be manufactured in compliance
with U.S. good manufacturing practices. They are not true
``generics''--they are fake products designed to fool U.S. citizens. in
Tijuana last year, we found products with familiar-looking packaging,
English labels, and U.S. bottles. some of the labels on these medicines
identified listed a non-existent U.S. company as the manufacturer.
Factories in India and China are the sources of most of the bulk active
used in counterfeit pharmaceuticals.
With the increase in international trade, it has become
increasingly difficult to trace the pedigree or lineage of any
particular counterfeit drug product. As I stated earlier, a product may
be sourced in one country, formulated into tablets or capsules in
another, packaged in yet another, and then transshipped through other
countries to its final destination.
Recently we have found that companies in India and China are
heavily involved in manufacturing the counterfeit drugs that eventually
make their way to the Mexican border and into the hands of U.S.
consumers. In fact, we currently believe that some products are sourced
in India, fraudulently labeled in the San Diego area, and then shipped
into Mexico for sale to unsuspecting Americans. A 1997 customs seizure
of more than $60 million worth of misbranded and counterfeit
pharmaceuticals that were destined for Tijuana drugstores tends to
support this theory. The active ingredients appear to have originated
from India.
Also, in numerous instances we have found bulk active that was
sourced in India, shipped to various European countries, and then
shipped to Mexico. The documentation provided with these products
indicated fraudulently that the product was sourced in Europe rather
than India.
Finally, there is substantial consolidation in the border trade.
During the PSI visit to Tijuana in September 1998, it was estimated
that there were approximately 800 pharmacies operating in the Tijuana
area alone. In august of last year, the number of pharmacies operating
in the border area around Tijuana had been reduced to less than 100.
Information has been received from reliable confidential sources that
Mexican organized criminal elements are involved in the distribution
and sale of counterfeit medicines in Mexico.
China is another significant source of the bulk active used in
counterfeit pharmaceuticals. We have found counterfeit pharmaceuticals
sourced from China all over the world.
Improved technology and the Internet have contributed to the expansion
of trade in counterfeit pharmaceuticals.
As web-based pharmacies proliferate on the Internet, so does web-
based counterfeiting. This is borne out by increased U.S. Customs
seizures over the past few years.
One dramatic example of web-based counterfeit was described by the
New York Times in March 2000. The U.S. Customs Service, along with Thai
authorities, conducted searches of online pharmacies based in Thailand.
Several arrests were subsequently made in Thailand along with six
individuals in Albany, New York. Officials seized 20 computers, 245
packages ready to be shipped, and over 2.5 million doses of drugs.
These counterfeit medicines are manufactured in unclean, nonsterile
sites, which certainly would not meet FDA approval.
FDA, DEA, and U.S. Customs Service lack the resources to police
effectively for counterfeit and diverted pharmaceuticals.
Improved packaging technology makes it difficult for even the
expert eye to differentiate between manufactured labeled product and
counterfeit labeled product. Certainly it is expecting too much to
expect a U.S. Customs inspector to make this judgment. Further, limited
resources affect the number of shipments that can be inspected at our
ports and borders by U.S. Customs inspectors. FDA and DEA have similar
resource constraints.
Conclusion
What can we and should we be doing to ensure that the world problem
in counterfeit and diverted pharmaceuticals does not become a
significant U.S. problem?
We must recognize that the U.S., as the largest and most lucrative
market in the world, is the ultimate target of many counterfeiters and
diverters. We must not make it any easier for criminal counterfeit
operations than we already have.
Therefore, we must continue to:
1. Maintain our political will and not allow the desire for low cost
medicines to undermine our commitment to protecting the public
health of U.S. citizens.
2. Ensure that we maintain comprehensive legislation to protect our
pharmaceutical industry and encourage innovation.
3. Aggressively enforce the laws designed to combat trade in spurious
medicines.
4. Maintain strong penal sanctions against individuals convicted of
violating the various drug laws.
Mr. Chairman and committee members, thank you for the opportunity
to express my views on this important subject.
Mr. Greenwood. Thank you very much, Dr. Glover, for that
testimony.
The Chair at this time would recognize James Christian,
Vice President and Head of Global Corporate Security, Novartis
International. You're recognized for 5 minutes.
TESTIMONY OF JAMES CHRISTIAN
Mr. Christian. Mr. Chairman and members of the committee,
my name is James Christian and as has been indicated I am Vice
President of Global Corporate Security for Novartis. Prior to
joining Novartis I spent 20 years with the United States Secret
Service, the last 5 years as a Special Agent in Charge.
At Novartis, one of my responsibilities is to oversee the
company's worldwide anti-counterfeiting operations. In the past
5 years, Novartis has participated with law enforcement and
health authorities in over 100 counterfeiting investigations in
33 countries and involving hundreds of drug products. I have
witnessed a considerable ingenuity and resourcefulness that
unlawful enterprises utilize to manufacture and distribute
ineffective and often unsafe counterfeit products. Drug
counterfeiters present a severe and growing threat to the
health and safety of U.S. citizens. Now is not the time to
weaken the country's defenses against such criminal activities.
Novartis has a compelling interest in protecting the medicines
that it currently markets as well as those under development.
This year alone, Novartis will spend more than $2.4 billion on
research and development. More importantly, patients using
Norvartis' products must have every confidence that the drugs
are safe and effective.
Counterfeit drugs are fake medicines, produced and packaged
to look like the genuine article. They include products
containing correct ingredients, incorrect ingredients, no
active ingredient, an insufficient quantity of active
ingredient or too great a quantity of active ingredient and
usually have phony packaging and labeling. Counterfeiters are
able to produce labels that are virtually indistinguishable
from the true labels. They can also make and stamp tablets with
company logos and put them in blister packs. We have scores of
examples of counterfeit expired and adulterated medicines. One
quick example that I'll show now is a product that is developed
and we've seized in Colombia. This is the raw material used to
make the tablets. This raw material is made up of boric acid,
floor wax and leaded highway yellow paint. From this they go to
the tablets and from the tablets they go to the blister pack
and the labeling. I have a number of other examples on the
table and a bagful of examples if committee members are
interested later in the program.
Production of counterfeit medicines is pervasive outside
the United States and is growing at an alarming rate. My
written testimony contains detailed information about the
extent of counterfeit activity in Latin America and Asia. As a
result of a fairly recent investigation in Argentina, for
example, 72 individuals were arrested, 7 tons of counterfeit
pharmaceuticals were seized, 49 different counterfeit drugs
were identified and 13 clandestine labs were dismantled and 5
print shops seized. In Colombia last year, more than 400
expired, adulterated or diverted or counterfeit products from
80 different pharmaceutical companies were seized by INVIMA,
the Colombian food and drug authority. Pharmaceutical companies
and law enforcement authorities have a difficult time
controlling international counterfeiting practices. Many
counterfeit pharmaceuticals are manufactured so cleverly that
it is virtually impossible for consumers, government officials,
law enforcement agencies, Customs officials to identify them as
counterfeit. Detection is made more difficult by the practice
now of mingling counterfeit, adulterated, expired, stolen and
genuine product. When this occurs random or sampling testing is
totally ineffective. Counterfeiters do not care about the
quality and safety of the product. The goal is to sell a fake
drug to an unsuspecting patient.
The United States cannot rely on foreign countries to
enforce their counterfeiting laws and regulations. Many
governments lack the interest, resources and technological
sophistication needed to address the problem. Counterfeit
products present a severe safety risk to patients. They are
deliberately fraudulently mislabeled with respect to their
identity and source. Active ingredients, if present, are often
in an incorrect amount. Frequently, there is no active
ingredient at all, but a completely different ingredient. They
might be manufactured in garages, basements or warehouses under
horrific conditions. I now have a videotape from Colombia that
is very short, but it will give you an idea of what these
clandestine labs that manufacture counterfeit money,
counterfeit products look like.
[Video shown.]
Now as bad as that looks, the final product, the quality is
almost impossible to tell from the genuine and certainly now by
a Customs Inspector.
Criminal counterfeiting operations have become more
aggressive, more sophisticated. The resulting danger to U.S.
consumer is greater than ever before. Now is not the time to
diminish the capacity of the United States to prevent
counterfeiting drugs from reaching our shores. it is time to
strengthen our commitment to keeping our medicines the best and
safest in the world. To do this, additional resources and a
much stronger mandate are necessary for organizations such as
U.S. Customs and the Criminal Investigative Unit of the FDA.
Their approach must be international in scope if we are to
maintain the present level of integrity in the U.S.
pharmaceutical system. If you go to Bogota, if you go to
Bangkok, you will find the presence of the FBI, the Secret
Service, the DEA. You will not find a Criminal Investigative
Unit of the FDA and yet this has the potential to be a much
bigger problem than the problems those agencies were
addressing.
Thank you.
[The prepared statement of James Christian follows:]
Prepared Statement of James Christian, Vice President and Head of
Global Corporate Security, Novartis International AG
My name is James Christian and I am Vice President and Head of
Global Corporate Security for Novartis International AG. Prior to
joining Novartis, I was a Special Agent in Charge with the United
States Secret Service where my responsibilities included suppression of
counterfeiting of U.S. currency in Latin America. At Novartis, I
oversee operations to protect the assets and reputation of Novartis in
the 140 countries in which the company markets its products or in which
the products or their raw ingredients are manufactured, packaged,
stored, or shipped. In this capacity, I have witnessed firsthand the
considerable ingenuity and resourcefulness that unlawful enterprises in
foreign countries utilize to manufacture and distribute ineffective and
often unsafe counterfeit products. There can be no question that
foreign drug counterfeiters take full advantage of offshore mail-order
pharmacies, the Internet, and visitors from other countries to market
their goods. Furthermore, if the United States permits the
reimportation of drugs as provided in legislation enacted last year,
the financial rewards for drug counterfeiters will ensure that they
make every effort to penetrate deeply the U.S. marketplace causing
considerable harm to the health and safety of U.S. citizens.
i. background
Novartis Group is a multinational research-based healthcare
business headquartered in Basel, Switzerland, with U.S. headquarters in
New Jersey. We have more than 67,000 employees worldwide with over
15,000 in the United States. The company's product line includes 126
prescription drugs to treat or prevent conditions as varied as
rheumatoid arthritis, schiozophrenia, hypertension, Alzheimer's
disease, high cholesterol, migraine headaches, epilepsy, cancer, and
organ rejection in kidney, liver, and heart transplants. Several weeks
ago the FDA approved our new orphan drug, Gleevec <SUP>TM</SUP>, for
chronic myeloid leukemia, which represents one of the most significant
cancer treatment breakthroughs in many years. Novartis has a compelling
interest in protecting the assets represented by the drugs that it
currently has in the market as well as those now under development. In
this year alone, Novartis will spend more than $2.4 billion on drug
research and development. More importantly, it is critical that
patients using Novartis products have every confidence that the drugs
are safe and effective. For these reasons, Novartis dedicates
considerable manpower and financial resources to addressing drug
counterfeiting on a global scale. Accordingly, Novartis works closely
with law enforcement and health authorities in numerous countries to
investigate and suppress the counterfeiting of its products.
ii. counterfeiting
Counterfeit drugs are ``fake'' drugs, produced and packaged to look
like the genuine article. Counterfeit drugs may include products
containing correct ingredients, incorrect ingredients, no active
ingredient, an insufficient quantity of active ingredient, and have
phony packaging and labeling. Illicit operations may combine
counterfeit product with adulterated or expired product, or on
occasion, with some genuine product to make detection more difficult.
Counterfeiters employ state-of-the-art technologies such as desktop
publishing to produce counterfeit labels that are indistinguishable
from the true original labels. These labels put false ``new''
expiration dates on expired products and make adulterated or
ineffective drugs look like the real thing. Counterfeiters have the
ability to make and stamp tablets with company logos and even to
package them in blister packs.
While we have scores of examples of such activities, there are some
that demonstrate the deceit and danger inherent in drug counterfeiting:
(1) A raid on a counterfeiter's facility uncovered tens of thousands of
vials of a drug whose expiration date had long-since passed.
The vials were soaked in hot water to remove the old labels,
and counterfeit labels bearing a new expiration date were
affixed. In similar circumstances, drugs in vials and ampules
have lost their efficacy because their temperatures were raised
to unacceptable levels during the label-removing process.
(2) Our efforts also interdicted millions of yellow tablets that were
virtually indistinguishable from the genuine product--including
the company logo. These tablets were made of boric acid, floor
wax, and lead-based yellow paint used for road markings. Sacks
of these ``raw materials'' were stacked throughout the
counterfeiter's site.
Counterfeiting is prevalent outside the United States and is
growing at an alarming pace. A joint workshop of the World Health
Organization and the International Federation of Pharmaceutical
Manufacturers Associations concluded in 1992 that in some countries as
much as 60 percent of all drugs may be counterfeit. Since then, every
major pharmaceutical company has seen an increase in the volume of
counterfeit medicines. Over the last five years, Novartis has assisted
or otherwise been involved in over 100 investigations of counterfeiting
operations, in over 33 countries, involving more than 11 Novartis
products and more than 200 products manufactured by other companies.
A survey of the international media demonstrates that the problem
of counterfeit, substandard, contaminated, and poisoned drugs is
worldwide--fake Xenical in Hong Kong, phony ampicillin and AZT in
Vietnam, counterfeit Mefloquine in Cambodia. Recently in the United
States, counterfeit fertility drugs have been found in New York and
phony Propecia and Viagra discovered in Boston. Counterfeiting and
diversion are particularly prevalent and dangerous in Latin America and
Asia.
Mexico and Central America. Counterfeit products are a major
concern in Mexico, Central America, and the Dominican Republic.
Counterfeiting in Mexico is particularly dangerous for American
consumers because of the shared border between Mexico and the United
States. U.S. consumers traveling over the border to Mexico to buy
products off pharmacy shelves may purchase dangerous counterfeit or
adulterated products. A recent article in the New York Times reported
that a chemical analysis had found several sampled Mexican drugs to be
counterfeit--including an anti-depressant, an ulcer treatment, and a
diabetes medication. American law enforcement officials opined that the
amount of counterfeit and substandard medications in Mexico could be as
high as 25 percent. Based on our knowledge, the problem could be much
larger. Moreover, in my experience, U.S. Customs and FDA lack the
resources and infrastructure to police the border adequately to prevent
criminal smuggling of bulk counterfeits from Mexico to the U.S.
Argentina. From May 1999 until June 2000, Novartis worked with
authorities in Argentina to combat the counterfeiting of four Novartis
products--Voltaren (an anti-inflammatory), Tegretol (an anti-
epileptic), Hydergine (dementia), and Reliveran (arthritis). As a
result of that investigation, 72 individuals were arrested, 7 tons of
counterfeit pharmaceuticals were seized, 49 different counterfeit
pharmaceuticals were identified, 13 clandestine labs were dismantled,
and 5 print shops were seized.
Brazil. In early 1999, it became apparent to the pharmaceutical
industry that there was a major counterfeit pharmaceutical problem in
Brazil. At that time, 132 counterfeit products--from most major
companies--were identified as being distributed in Brazil. The
Pharmaceutical Security Institute (an industry organization formed to
support anti-counterfeiting efforts) working with the Brazilian
Minister of Health trained a team of 25 investigators to attack the
counterfeit medicine problem. Approximately 20 clandestine labs were
seized and numerous arrests were made.
Colombia. Counterfeit drugs are manufactured in Colombia for
international distribution. In 2000 alone, more than 400 products from
80 companies, either expired, adulterated, diverted or counterfeit,
were seized by INVIMA (the Colombian food and drug authority) working
with Novartis and other multinational pharmaceutical companies.
Investigations, raids, and seizures are continuing with extraordinary
results. So far, approximately 6 million ampules of counterfeit
Voltaren have been seized. Tens of millions of counterfeit tablets of
another pharmaceutical company's non-steroidal anti-inflammatory drug
have been seized. Dr. Miguel Rueda, Director of INVIMA, believes that
the counterfeit, expired, and altered drugs were to be distributed not
only in Colombia but also in Ecuador, Peru, Venezuela, and Central
America. While INVIMA is working hard to combat the problem in
Colombia, the necessary resources are not always available.
Asia. The counterfeiting of pharmaceuticals is a burgeoning problem
in China. For example, in March 2001, Novartis and other pharmaceutical
companies participated in a raid with authorities in Shantou that
resulted in the seizure of over 1800 cartons of counterfeit
pharmaceutical products from 14 multinational companies.
India. Another threat to U.S. consumers relates to the distribution
of bulk pharmaceutical products from India. India refuses to recognize
intellectual property rights and as a result, through process patents,
Indian companies manufacture and ship patent-protected bulk
pharmaceutical products around the world. Technically, the Indian
products should only be shipped to countries that recognize process
patents, but in fact much of this bulk product shows up in countries
that recognize product patents. In fact, there is reason to believe
that some of this material is shipped to the United States for
manufacturing and packaging, and then exported to other places such as
Mexico. Often the product ends up back in the United States when
American citizens go to Mexico to purchase pharmaceuticals. Health
authorities in a number of Latin American countries believe that India
and Cuba use the region as a dumping ground for batches of
pharmaceuticals that are substandard. For example, health authorities
have discovered products without sufficient active ingredient and
contaminated with foreign materials including pieces of glass. Those
products can be sold to U.S. consumers in Mexico or may be smuggled
into the U.S. and placed on U.S. pharmacy shelves.
iii. lack of control of counterfeiting
Novartis, like other drug companies, and, unfortunately, law
enforcement authorities are hampered in the effort to control
international counterfeiting practices by several factors including:
(1) the difficulty of detecting counterfeits; (2) the lack of dedicated
resources in local jurisdictions and the failure to give appropriate
priority to anti-counterfeiting activity; (3) the ingenuity of
counterfeiters and the ease with which criminal elements can resume
operations at new sites; and (4) the lack of applicable criminal
statutes and the prevalence traditionally light sentences.
Inability to detect. Many counterfeit pharmaceuticals are
manufactured so cleverly that it is virtually impossible for consumers,
government officials, and law enforcement agencies to identify them as
counterfeit. Counterfeiters do not care about the quality and safety of
the product. They concentrate their resources on the appearance of the
product and its packaging. The goal is to sell a cheap, fake product to
an unsuspecting consumer, not to provide a safe and effective medicine
to a patient. It can be virtually impossible for consumers to tell the
difference between a counterfeit and a genuine product. Even
pharmacists, doctors, and government regulators can be fooled. Field
tests can determine whether the active ingredient is present, but not
whether the active ingredient is present in the appropriate amount,
whether there are any impurities or foreign substances in the product,
or whether the product is expired.
The ability to detect counterfeit products is made more difficult
by the practice of combining counterfeit product, adulterated product,
expired product, and genuine product. Distributors supply the resulting
intermingled combination to physicians, hospitals, pharmacies, and
health agencies. Such shipment might be 50 percent ``bad.'' If a test
is performed on a genuine pill from the intermingled shipment, the
counterfeit shipment passes undetected.
Lack of enforcement. Many countries fail to enforce their
counterfeiting laws vigorously. Local jurisdictions frequently lack the
resources and technological sophistication needed to address the
problem. Some countries spend their resources on other national
priorities and not anti-counterfeiting activities. In other countries,
criminal operations have infiltrated the law enforcement and regulatory
community, precluding effective enforcement of the law.
Professional criminal element. Drug counterfeiters may be extremely
large, sophisticated and well financed operations or, at the other
extreme, they may be small opportunistic enterprises. In Mexico, for
example, it is believed that most, if not all, of the pharmacies
located along the border, are owned and operated by Mexican organized
crime groups. In Latin America, crime syndicates bring together
manufacturing and printing skills and often link them with existing
pharmaceutical distributors. By the time a counterfeiting operation is
identified by a pharmaceutical company, it has generally been in
operation for some time. The subsequent investigation to develop facts,
identify suspects, and determine the locations of clandestine labs and
print shops can take years. During that time counterfeit drugs continue
to be produced. Oftentimes the company's investigation must be fully
developed before the local government will take any official interest
in the problem. Clandestine labs are usually crude and can be easily
shut down and reopened elsewhere by counterfeiters who suspect that
they or the location have been compromised. In my experience, the
professional criminals who engage in counterfeiting of pharmaceuticals
are able to elude arrest and prosecution by shifting their operations
from location to location and by taking advantage of delays in the
investigation process.
iv. the threat to u.s. consumers
There is ample opportunity for counterfeit products to enter the
United States across the Mexican border. A recent survey by the Drug
Enforcement Administration and U.S. Customs at the border between
Tijuana and San Diego revealed that a sample group of 200 travelers
returned to the United States with 28,409 dosage units. Assuming that
25 percent of Mexican pharmaceuticals are counterfeit or adulterated,
those 200 patients alone may have brought 7000 counterfeit or
adulterated doses into the United States.
Counterfeit products present a severe safety risk to consumers.
Counterfeit products are deliberately and fraudulently mislabeled with
respect to their identity and their source. They might be manufactured
in garages, basements, and warehouses. The manufacturers do not adhere
to good manufacturing practices. There is no guarantee the products
were manufactured in a sterile environment, and no information about
how the products were packaged, stored, handled, or shipped. Active
ingredients, when present, are often in an incorrect amount. Often
there is no active ingredient at all, or a completely different
ingredient. If the medication is intended for a serious condition, an
unexpected change in the dosage, the substitution of an illegal
ingredient, or the lack of an active ingredient could well be life
threatening. If the medication is intended for a serious and chronic
condition, a month's supply of counterfeit drugs could place the
consumer's long-term health in jeopardy.
Additional problems arise with expired and adulterated medicines.
Parallel trade and diversion of medicines often results in labels being
changed so that they are in the local language. There are instances
where the products lose efficacy during the label change process.
Labels are often added to outdated products, giving the appearance that
the shelf life is much longer.
v. conclusion
In 1987, the House Energy and Commerce Committee concluded that
permitting re-importation of American drugs ``prevents effective
control or even routine knowledge of the true sources of merchandise in
a significant number of cases.'' As a result, ``pharmaceuticals which
have been mislabeled, misbranded, improperly stored or shipped, have
exceeded their expiration dates, or are bald counterfeits, are injected
into the national distribution system for ultimate sale to consumers.''
Indeed, ``the very existence of the market for reimported goods
provides the perfect cover for foreign counterfeits.'' Since 1986,
criminal counterfeiting operations have become more numerous, more
sophisticated, and more aggressive. The resulting danger to U.S.
consumers is greater than ever before. Now is not the time to weaken
the ability of the United States to prevent counterfeit drugs from
reaching U.S. citizens. If reimportation of prescription drugs resumes,
Congress will soon be holding hearings to determine how to stop the
flow of dangerous counterfeit medicines into the United States.
Mr. Greenwood. Thank you, Mr. Christian.
At this time, the Chair would recognize William Trundley,
the Vice President of Corporate Security Investigations,
GlaxoSmith
Kline.
TESTIMONY OF WILLIAM TRUNDLEY
Mr. Trundley. Mr. Chairman, members of the committee, thank
you for inviting me to testify today. My name is Bill Trundley,
I'm the Vice President of Global Corporate Security and
Investigations for GlaxoSmithKline and I'm based in London. I
have responsibility for investigating counterfeit crime against
the company and its customers worldwide. Prior to joining
GlaxoSmithKline I was the head of Security for the Bank of
England with additional responsibility for the secure
production, storage and distribution of the Euro banknote
including introducing anticounterfeiting measures. Prior to
that, Mr. Chairman and members, I was in the British Army for
24 years with the Special Investigation Branch with
responsibility for the conduct of some anti-terrorist and
intelligence operations.
I intend now to make a short presentation to demonstrate
the widespread incidents of counterfeit product within the
global marketplace. As you can see, it's almost impossible for
the consumer to tell the difference between genuine and
counterfeit products. Look at the silver foils and the blister
packs to see just how far the counterfeiters will go to copy
the real thing. This particular counterfeit product was
manufactured in Taiwan in sufficient quantity to supply the
local market for 3 months. It's easy for the counterfeiters to
copy batch codes or make their own packaging. Furthermore,
there is simply no guarantee that reimported medicines are
genuine or if they are genuine while out of the country they
have been stored under the appropriate conditions.
This particular product is an antibiotic and was found on
the market in South America. The product is designed to be used
intravenously as well as in suspension in tablet form. This
counterfeit version has no active ingredient.
This product is used exclusively for the treatment of HIV.
The product was found to be totally ineffective. It was on the
marketplace in Hong Kong. Criminals will exploit loose controls
to introduce similar counterfeit medicines into the U.S.
marketplace. The net result will be to put the lives of
patients at risk. The taxpayer or the purchaser of the
medicines becomes the victims of wholesale fraud if they're
duped into using products that have been switched for the
counterfeits.
Dermavaid creme is used to treat skin complaints. this
product found its way on to the U.K. market from India, despite
strict EU importation laws. On analysis, it was found to be
dangerous for use on the human skin. And I have to say that by
relaxing its import conditions, the U.S. is making itself more
vulnerable to this sort of practice.
The package on the right is counterfeit, but can anybody
here tell the difference easily? This slide relates to a case
that is only 3 months old, so please don't think it's an old
problem that no longer exists. This product is used for
reducing pain and was found on the market in the Far East and
in Sub-Saharan Africa. One other point, I should make is that
if a product is potentially harmful, it may be impossible to
conduct proper recall as the audit trail will be all but lost
once the product has been sent abroad. One example of a fatally
harmful product is the case in 1994 which members may be aware
of when over 200 children in French Niger died as a result of
being vaccinated with what later transpired to be contaminated
river water. This was during a government-sponsored vaccination
program.
This particular product is used to treat acne. Personally,
I would not allow my teenage children to rub this counterfeit
product into their face. This was discovered in the Philippines
and you can see from the quality of the packaging the lengths
to which the counterfeiters will go to.
This product is used for the treatment of asthma in
children and as you can see it was discovered in Brazil 23
years ago. The counterfeit version has no active ingredient.
Now please compare and contrast this appalling trade with
the companies that each invest billions of dollars every year
in research and development to ensure the safety and efficacy
of the product where the products are manufactured in sterile
conditions and to high standards of GMP and GLP. And the
ethical producers are subjected to continual testing and
quality control to ensure the safety and efficacy by both in-
house and the Federal authorities.
This is in marked contrast to criminal operations. This
slide shows how the counterfeit Zantac was manufactured in
Taiwan. The conditions are quite appalling.
This is a slide that shows how the counterfeit Panidol was
made. As you can see, the product was made in sweatshop
conditions and the circumstances that are wholly unacceptable.
This final slide shows the dreadful conditions in which
counterfeit medicines are mass produced and stored. The
photograph was taken during a raid on premises in Manilla that
resulted in the discovery of the counterfeit acne cream. I
would like to emphasize, Mr. Chairman and members of the
committee that despite having strong controls in the European
market, counterfeit products still find their way on to the
marketplace. The United States represents 40 percent of the
global pharmaceutical market. It is therefore the most
attractive and lucrative market and one which the
counterfeiters would naturally turn to.
Counterfeit product is made in primitive, dirty and
dangerous conditions, often exploiting cheap, unskilled, local
labor. At best, counterfeits do not contain active ingredients.
At worst, they can be positively harmful and fatal.
Finally, more often now, medicines are sold direct to the
customers through the Internet or mail order. This makes it
even more difficult for them and the authorities to know
whether or not the product they're using is safe.
Mr. Chairman, members of the committee, thank you very
much.
[The prepared statement of William Trundley follows:]
Prepared Statement of William Trundley, Vice President, Corporate
Security and Investigations, GlaxoSmithKline
Mr. Chairman, members of the Committee, I am Bill Trundley, Vice
President of Corporate Security and Investigations, at GlaxoSmithKline
which is a research-based pharmaceutical firm. The company has US
headquarters, research and development, and manufacturing facilities in
both North Carolina and Pennsylvania. GlaxoSmithKline employs over
20,000 personnel in the United States and 90,000 elsewhere around the
world.
The purpose of this testimony to your subcommittee is to briefly
discuss some of the Company's experience with those who produce
counterfeits of our medicines, and to give you some perspective on the
scope of this problem. The issues are with public safety because: there
can be no guarantee that re-imported medicines have been stored under
the correct conditions to ensure their efficacy; the audit trail will
be all but lost once the product has left the country, making it almost
impossible to guarantee a successful recall of the product if this
becomes necessary; and criminals will exploit any perceived loosening
of controls to place counterfeit product into the US legitimate market.
First, as to scale, the World Customs Organization has estimated
that ``around 5% of all world trade may be falsified, and in view of
the relative ease with which pharmaceutical products can be
counterfeited and transported, there is little reason to expect a lower
figure for such products.'' Current estimates of the cost of
counterfeit medicines range from 6 to 12 billion dollars each year.
Counterfeiting is most prevalent in developing countries, but there
is always the risk that these products could find their way into almost
any country. Former FDA Commissioner Jane E. Henney has said that she
and her Canadian counterpart are concerned that, if imports were
allowed, the U.S. demand for drugs from Canada could cause Canada, and
I quote, ``to somehow be used as a front for counterfeit or
contaminated products . . . one has to be concerned about safety issues
here.'' End quote.
While the size of counterfeiting operations can vary from a small
back-room unit to a larger factory-like facility, the one common thread
is the complete lack of regard the counterfeiters have for the
regulatory and quality control framework that exists for the
manufacture of ethical pharmaceuticals.
Their formulations and raw materials have not been tested in
clinical trials, monitored for adverse reactions nor proven to meet the
label claims of efficacy or stability throughout the claimed shelf
life. They may use cheap substitutes for active ingredients, the wrong
active, or even no active at all. Their processes and equipment are not
validated, and they probably operate without any monitoring of product
specifications. False documentation is used to help introduce the sub-
standard goods into the legitimate distribution chain.
Unfortunately, however, it is relatively simple to produce a
counterfeit that, on the surface, looks remarkably similar to the
genuine article.
Counterfeit medicines are also a cynical exploitation of the trust
patients place in pharmacists and other health care providers. The
counterfeiters rely on the reputation and good name of prescribers,
manufacturers and their products in order to defraud, and possibly
harm, an unsuspecting and vulnerable public. The most troubling aspect
of this crime is its negative impact on the lives and well being of
patients. The net result is to put the lives of patients at risk, as
they may unwittingly be sold counterfeit or sub-standard medicines as
part of life-saving treatment or for pain relief. Patients may then
lose confidence in the product and in the medical profession as a
whole, causing them to stop their particular course of treatment. The
taxpayer will become the victims of fraud if they are sold products
that have been switched for counterfeits or for sub-standard medicines.
This will result in serious harm to legitimate business such as the
manufacturers, the distributors and the retail pharmacies.
Let me quote a few examples:
<bullet> In Ghana, ten percent of all hospital deaths are due to fake
or subpotent medicines.
<bullet> In 1996, hundreds of Nigerians either died or suffered
permanent brain damage from a counterfeit version of a
meningitis vaccine.
<bullet> In 1997, fake medicine killed 88 children in Haiti.
<bullet> 223 children died in Bangladesh over a two-year period after
taking fake anti-malarial pills.
<bullet> One study showed that only one quarter of all medicines bought
from street vendors in Nigeria were genuine.
Let me leave you with the thought that, while the counterfeit
productslook similar to real medicines, the operations that produce
counterfeit medicines bear little or no relation to the facilities
required to produce genuine medicines. I believe the scale will
increase in a very short period of time, particularly when internet and
mail order selling becomes more widespread as there will be even less
opportunity for the customer to be sure that it has been purchased from
a trustworthy source.
Our manufacturing facilities and standards are complex and
rigorous. Our whole operation is subject to rigorous control and
inspection both inhouse and by the Federal Authorities to ensure the
safety and efficacy of the product. The counterfeit operations, on the
other hand, are not. This is indeed a case where one cannot judge a
book (or a medicine) by its cover.
Thank you for allowing me to testify on this important topic. I
will be happy to answer any questions you may have relating to our
interest in this issue.
Mr. Greenwood. Thank you, Mr. Trundley for your testimony.
We appreciate it.
Mr. Haislip for 5 minutes.
TESTIMONY OF GENE R. HAISLIP
Mr. Haislip. Good afternoon, Mr. Chairman, distinguished
members of the committee, my name is Gene R. Haislip and I'm a
consultant to the pharmaceutical and chemical industry.
Mr. Greenwood. Mr. Haislip, let me interrupt you. Is your
microphone turned on? Just pull it a little closer and speak
into the silver one, not the black one.
Mr. Haislip. Sorry. Thank you. I'll start again. Good
afternoon, Mr. Chairman, distinguished members of the
committee, my name is Gene R. Haislip and I'm a consultant to
the pharmaceutical and chemical industry in the area of
controlled substances and chemicals which, as you've heard this
morning, are frequently diverted from legitimate channels into
the illicit drug traffic. Prior to that I served most of my
career in the Drug Enforcement Administration and during the
last 17 years of my service I was the head of the Office of
Diversion Control which is the office in DEA that has
responsibility for all the programs, investigations and
activities dealing with that subject and I'm very pleased to
have this opportunity to address you on I think what we all see
as an extremely important and sensitive area and a growing
problem and that is the problem of counterfeit pharmaceuticals.
I have submitted a lengthy statement for the record and
with your permission I'll just proceed to summarize some of the
main points and then answer such questions as you may have.
Well, counterfeiting controlled substances is not new. It's
been going on for quite some time. And it's a very interesting
and important problem and I have detailed some of the
extraordinary experiences we have with that in my testimony.
One of the situations that I mention is very unique, I think,
because it was a case in which at its height really most of the
factories that produced this particular drug it was called
quaaludes in those days, most of the factories in the world
producing that particular drug were really just producing it
for the illicit drug traffickers. They were virtually the only
real customers for that commodity. Very little of it was being
sold to any legitimate enterprise. And in addition to that, of
course, they were counterfeiting a product that was available
in the United States, but at that time the legitimate product
had only become about 5 percent of the total quantity of that
drug which was available in the United States. In other words,
about 95 percent of it was the counterfeit product that had
been smuggled into the country from Colombia where it had been
counterfeited. And so I think that that case is interesting to
me because it shows just how far things can go.
Well now we see that in addition to this historical
counterfeiting of controlled substances, there's a growing
problem of counterfeiting of general pharmaceuticals of all
varieties and for virtually all medical purposes and like the
counterfeiting of controlled substances, it too is almost
exclusively an international problem. That is to say, it's a
problem that probably could not exist in the serious dimensions
that we're experiencing without the benefit of global commerce
and what it can provide to criminal organizations and I'd like
to just emphasize a few points about that, if I may.
Well, the first thing I'd like to point out is this is not
really something that's very difficult to do. It's quite easy
to obtain all the raw materials and all of the technology that
you need to produce the products that you have seen in the
various demonstrations this morning and a lot of times, I mean
if you wish to, you can do this indirectly and retain your
anonymity by simply using brokers in some of the major
commercial cities of the world. It's the broker that finds the
source of these materials and the source, the manufacturer,
supplier, never knows who the customer is. The source is
dealing with the broker and the broker is dealing with the
customer and by the way for whatever reasons, depending upon
what you're trying to do, if you need for those goods or that
you've purchased to change identity or to change their source,
this can be done for you too and it's customarily done in some
of the great free trade zones of the world. These are special
zones that you find particularly in the Caribbean and in Europe
and also in parts of Asia. We don't really have that
institution in the United States. Sometimes it's called that,
but it's not really the same. Well, in those free trade zones,
the goods that are being purchased in this case by criminal
organizations come into the free trade zone. There is very
little record keeping required and no inspection of these
commodities because they're regarded by the country that
they're entering as being just in transit. So it cannot
possibly be a problem for them, whatever it is. They're simply
there in transit.
But they're there in transit, you can take them into your
own warehouse. You can rent space within a free trade zone
because it's not something like this room here. It's more like
a small city, usually behind a fence and there, you can do
whatever you need to do. You can even do your counterfeiting
there, but if you need to change the identity of those goods,
or if you need to repackage them or relabel them you can do
that there and they leave the free trade zone as something that
did not--they were not, when they arrived. So as I've often
said, things come into that free trade zone and they just
disappear because they never come out the other end. Something
else comes out the other end. So I think that's important to
remember in terms of any idea of trying to control the source
of much of this international commerce. And as far as
production, well, I think you've seen some of the examples of
some of the incredibly crude production that really dominates
most of this activity, but sometimes it's quite sophisticated
because we have cases in which criminal organizations have gone
to parts of the world where for political and economic reasons,
there's a lot of desperation and they can corrupt the factory
management. In one case, in this particular case in Eastern
Europe, a secret facility was established within the factory,
just known to a few employees just to fill the orders of this
particular criminal organization for the particular commodity
they wanted and even went so far as to purchase one of the top
of the line brand new German tableting machines that could
produce 400,000 tablets an hour to install in this secret
facility and if that's not something that's convenient, can't
find the right factory to try to corrupt, then you can--some
countries, you can rent a factory. You can go to India and
places like that, you can rent a factory for the weekend or
maybe just for night time or a couple of weeks or whatever you
want to do. All of the equipment is there, they really don't
inquire as to what you're doing if you can pay the rent. So
that's another option. And then we've seen in a number of cases
an incredible thing of criminal organizations really
establishing what amounted to their own little miniature
pharmaceutical factory, buying brand new reaction vessels, the
vats, drying apparatus, all the piping, ductwork, everything
they needed in a secret facility, usually somewhere in the
suburbs. This particular one was in a large European capital
city.
Well, the second point that I'd like to make is that many
of the examples I've given in my testimony concern controlled
substances, but I want to make the point that in dealing with
these problems in regard to controlled substances, difficult as
it is, DEA and others do have some advantages. There is an
international infrastructure which exists. There are three----
Mr. Greenwood. Mr. Haislip, I don't want to be rude, but we
need you to summarize and we'll get back to you in questions.
Mr. Haislip. Thank you. I'll try to do that quickly. So
there are some advantages in some of these cases, but in the
case of general pharmaceuticals there is no international
infrastructure that we can take advantage of. I'll just close
by mentioning three points that I'd like for you to give some
consideration to. The first is I think this problem has to grow
and so we do really need to increase our law enforcement
capability to deal with it. The second is I think there's a
need to simplify our laws and make them more practical and
workable because really in many cases now they're too baroque
and they probably will not really work and last is, it's time
to consider some kind of major diplomatic effort to create the
kind of international infrastructure we do not have. I
apologize for going over time. Thank you very much.
[The prepared statement of Gene R. Haislip follows:]
Prepared Statement of Gene R. Haislip, Consultant, Controlled Drugs and
Chemicals, Law, Policy, Administration and Enforcement
Mr. Chairman and distinguished members of the Committee, my name is
Gene R. Haislip and I am presently a consultant to the pharmaceutical
and chemical industry on issues involving controlled drugs and
chemicals. I served for 29 years of my government career in the US Drug
Enforcement Administration and, for the last 17 years, was the head of
the agency's Office of Diversion Control from which I retired as a
Deputy Assistant Administrator of DEA in March of 1997. This is the
office responsible for all of the control and enforcement programs
dealing with legitimate drugs and chemicals that are diverted into the
illicit drug traffic. I am also now assisting the United Nations Drug
Control Program in the design and implementation of a chemical control
program in the Central Asian Republics bordering Afghanistan.
I am very pleased to have this opportunity to testify before you
today on a subject of great importance to our fellow citizens and one
that has occupied so much of my professional effort. It is my sincere
hope that I will be able to make some small contribution to your
deliberations.
Drugs and pharmaceuticals have become a major and pervasive social
concern both because of their life-giving benefits and, in many cases
their debilitating abuse. It is crucial that we take measures to
minimize these abuses and at the same time, seek to insure that our
citizens can rely upon the efficacy, and purity of their medications.
The extraordinary availability of technology, the speed and ease of
global commerce and the ingenuity of the criminal mind have resulted in
the massive diversion and illicit manufacture of drugs of abuse and
have also begun to undermine the integrity of vital medicines by the
trafficking in bogus, counterfeit products which may cause the death or
injury of innocent, unsuspecting persons.
Much of what I will relate in my testimony deals with the problems
of the diversion, clandestine manufacture and counterfeiting of that
smaller group of pharmaceuticals known as controlled substances.
However, the lessons of this experience are absolutely critical to
understand the challenges that we face in dealing with all classes of
pharmaceuticals. In most cases, the criminal technique employed for
one, are essentially the same for the other, except that in the case of
non-controlled products, we lack many of the basic tools with which to
attack these problems. Hereafter, I will attempt to develop this in
greater detail, but first, some basic statement of the situation is
necessary to establish a context.
i. nature of the problem
The demand created by addicts and drug abusers is obviously of
quite a different nature than that of legitimate consumers for the
medicines they require. Yet there is a certain similarity which in both
cases may result in stimulating the traffic in counterfeit
pharmaceuticals. Although most people commonly think of the illicit
drug traffic in terms of such drugs as heroin, marihuana or illicit
cocaine, in fact, many important legitimate drugs are also powerful
narcotics, stimulants or depressants that are frequently sought by drug
abusers.
Just like other consumers, drug abusers and addicts have learned
the various brand names and appearance of the drug products they are
seeking. Consequently, drug traffickers employ every criminal means
they can to obtain these legitimate products to sell to their customers
at tremendously inflated prices. But because of controls, it often
happens that these products cannot be obtained in sufficient quantity
from legitimate sources and drug traffickers undertake to counterfeit
their own dosage forms to meet the demand.
In a similar fashion, criminal organizations sometimes seek to meet
the legitimate demand for brand name pharmaceuticals by counterfeiting
inexpensive, perhaps entirely bogus dosage forms in order to defraud
both legitimate patients and manufacturers. If the legal and law
enforcement situation is inadequate to prevent such schemes, cheap,
impure, ineffective and perhaps highly toxic counterfeits can drive out
the legitimate product. This is the subject with which we are concerned
in this hearing.
ii. methaqualone diversion: a prototypic example
I know of no finer example of the capabilities of international
criminal groups to corrupt global commerce than the massive illicit
traffic in counterfeit Methaqualone tablets known as ``Quaaludes''
which occurred in the early 1980s. It is for me, largely a personal
story, but briefly worth the telling because it illustrates how far
such a problem can develop. All of these same conditions continue to
exist and generally characterize the traffic in all diverted and
counterfeit pharmaceuticals.
During the late seventies, a strong depressant drug known as
``Quaalude'' became a major drug of abuse, especially among
adolescents. This resulted in increasing addictions, overdose deaths,
and an extraordinary rate of automobile fatalities. At the time, a US
company was manufacturing about seven metric tons of the drug a year
for legitimate medical use and much of it was being diverted. Suddenly,
it had become a drug which was producing as many deaths and injuries as
either heroin or cocaine.
By 1980, we had determined that the country was being inundated by
these Quaalude pills in such extraordinary quantities as to far exceed
national production. By reviewing the DEA daily enforcement reports, it
soon came to my attention that shipments containing one and two tons of
these pills were being seized almost weekly from small aircraft that
had originated in Colombia. The tablets turned out to be counterfeits
but were equally potent and usually contained the 300 milligrams of the
drug just like the legitimate US product.
A quick check revealed that this synthetic drug was not
manufactured in Colombia and I set off for Colombia, and particularly
the port of Barranquilla, with the task of discovering the original
source of this material. As a result, the Colombian Customs and
National Police were soon making the seizures which permitted us to
gradually piece together the entire story of this traffic and put an
end to it. It is one of the very few complete victories of our
enforcement efforts, in that this huge billion-dollar traffic was
eliminated. Here is what we found.
The Colombian drug traffickers had identified every known source of
the legitimate manufacture of this drug, which involved countries in
Western Europe, Eastern Europe and Asia and brokers and free trade
zones in many others. Through one technique or another, they were
purchasing virtually the entire global production of bulk Methaqualone
powder for eventual shipment to Colombia where it was rendered into
counterfeit Quaalude tablets exactly like the popular legitimate
product produced in the US. As a result of establishing the production
capacities of these foreign facilities and the large seizures which we
began to make, I estimated that approximately 150 metric tons of the
bulk drug was being diverted and counterfeited each year. This was more
than twenty times the quantity of the legitimate pills then being
manufactured. In other words, the world's factories were mostly
supplying only the drug traffic, and the legitimate product represented
only about 5% of the total availability. Congress finally eliminated
all manufacture of this drug in the US and it has also ceased to be
manufactured globally.
iii. diversion techniques
What is most instructive is the manner in which all of this was
accomplished. There were essentially two ways in which the material was
obtained from source manufacturers. The most common method was to place
orders through brokers, usually operating in the great free trade zones
such as Rotterdam or Hamburg, or in Switzerland. In this way, neither
party knows the identity of the other and the shipment is protected
from scrutiny by Customs authorities that routinely make no examination
of goods in transit. These are considered harmless because they are not
staying in the country and can do no harm to their temporary host!
Moreover, if special labeling and shipping arrangements are desired in
order to evade attention while in transit or upon arrival, it is easy
to find a broker who will oblige. Essentially, the drugs enter the free
trade zone and disappear from the face of the earth. The manufacturer
may wonder who is ordering such quantities of drugs but has no legal
responsibility to inquire.
The other method of obtaining the drug was to deal directly with
the manufacturer. In one case, traffickers sent representatives to a
foreign factory with suitcases full of US dollars to negotiate for
multi-ton shipments. Their attempt to corrupt the management at this
factory--which was partly owned by the foreign national government--was
successful. As will be seen, similar, and even more blatant situations
of the absolute corruption of factory management have arisen.
iv. clandestine production and counterfeiting
In the case of Methaqualone, all of the active pharmaceutical
ingredients (APIs) were purchased from legitimate sources and the
actual counterfeiting occurred in Colombia. This is perhaps the easiest
part of any clandestine operation. Used multi-stage tableting machines
are readily available on the international market or they may be
purchased new without arousing suspicion. It is also probably easy to
substitute candy machines, which perform essentially the same functions
as tableting machines. Counterfeiters are also quite capable of
manufacturing capsules, ampoules, and blister packs. This is often seen
on the Mexican border in the traffic in counterfeit steroids, while
capsules have been used for counterfeit amphetamines (Black Beauties)
beginning in the early seventies.
In the course of investigations of this type, it is quite common to
find that persons with professional experience in the legitimate
chemical and pharmaceutical industry have been recruited to perform the
technical functions for which they were trained. On occasion, these
individuals will in fact contact former colleagues still employed in
legitimate enterprises and who are usually innocent of the purpose, to
obtain sources or supplies.
If the desired bulk material (APIs) can not be purchased,
arrangements can be made for its production. This is more likely to
occur in those situations where legitimate facilities are experiencing
financial difficulties, such as in Eastern Europe or in developing
countries. In one such case, arrangements were made with the director
and chief chemist of a struggling East European factory to establish a
secret production facility within the company's 17-acre campus. It was
easy to obtain the necessary chemicals without arousing suspicion and
to relocate production equipment. To complete the arrangement, a new,
top-of-the-line tableting machine which could produce 400,000 tablets
per hour was purchased from a German firm. In another case, in a
neighboring country, it happened that this factory was a producer of an
important precursor material and some of the management and personnel
decided to use it to establish an illicit production facility within
the company. Unfortunately, as a result of political upheavals and
marginal economies, there are many such situations like these, which
are often ripe for corruption.
If it is not possible to corrupt the management of a suitable
facility, in some countries a criminal organization may rent an
existing facility during evenings or for weeks or weekends. But it may
be more expedient to build your own facility. There are examples in
both Western and Eastern Europe in which this has been done for drugs
such as MDMA and Methamphetamine. In these cases, very knowledgeable,
well-funded criminal organizations acquired a suitable site in the city
or the suburbs and proceeded to purchase brand new, top-of-the-line
reaction vessels, tableting machines and vats and piping and dryers.
These were small but modern, up-to-date, elegant production facilities
costing more than a million dollars. In one of the more fascinating
cases, a group of traffickers purchased large lots of cocaine in
Colombia for distribution in Europe to finance their secret factory in
a European capital. This factory was intended to supply illicit markets
in both Europe and the US.
v. packaging and distribution
Counterfeit packaging is generally no more difficult than
counterfeiting tablets. In most cases, only the original legal
manufacturer of the real product can tell the difference, and then only
on close examination and search of records.
Distribution is probably the most difficult and risky activity of
pharmaceutical counterfeiters. If the product is destined for the
illicit drug traffic, it involves all of the risk attendant to the
smuggling of heroin or cocaine. If the product were intended for
legitimate consumption, the task would be much easier. The product
itself appears to be legitimate and would cross Customs barriers with
less notice and suspicion, especially since the services are focused on
illicit drugs and commodities which require so much of their effort.
Certainly, it is easy to establish a ``front company'' with four or
five employees to receive and market the goods to legitimate
distributors. Such ``companies'' have been routinely used in the US to
import precursor chemicals for distribution to illicit manufacturers of
Methamphetamine. Of course, the ease with which this can be
accomplished will depend on the strength and enforcement of national
legislation.
vi. diversity of counterfeit pharmaceuticals
A. Drugs of Abuse
In the examples above, I have dealt primarily with the controlled
pharmaceuticals that concern DEA. Before turning to other areas, I
should like to complete this picture with a very brief summary, as the
example given is only remarkable because of its scope and effect upon
the US.
In the early 1970s, large quantities of secobarbital and
amphetamine were imported into Mexico for the clandestine production of
counterfeit capsules for illicit distribution in the US. These capsules
closely resembled the products that had been previously obtained by
traffickers from the Mexican subsidiary of a US firm. When their source
of supply was cut off, they simply continued their illicit business
with counterfeits. The same situation appears to have developed as a
result of the control of steroids. When the diversion of these drugs
was virtually eliminated by act of Congress in 1990, sophisticated
counterfeit products immediately increased along the Mexican border.
In recent years, Europe, Africa, Asia, and the Middle East have all
experienced similar large-scale diversion and counterfeiting of drugs
of abuse. These include a variety of stimulant drugs ranging from
amphetamine to Fenetylline, pemoline, amfepramone, and phentermine. It
appears that both legitimate and clandestine manufacturing sources of
bulk material have been used at various times. Clandestine laboratory
and counterfeiting facilities producing such materials have frequently
been seized in the Balkans and major points of sale and distribution
are focused on Africa and the Middle East. Other commonly counterfeited
products include Mandrax (the European form of methaqualone), Diazepam
(Valium), Flunitrazepam (Rohypnol) and other benzodiazepines.
B. General Pharmaceuticals
The evidence suggests that the counterfeiting of other classes of
pharmaceuticals is equally widespread. The first international effort
to define the problem was a workshop organized by the World Health
Organization (WHO) together with the International Federation of
Pharmaceutical Manufacturers Associations (IFPMA) in Geneva in April of
1992. It found that the counterfeiting of medicines had greatly
increased and involved billions of dollars annually. A recent list of
actual case reports from various countries included the following types
of counterfeit medications: antibiotics, diuretics, antimigraines,
antiparkinsonians, analgesics, antispasmodics, muscle relaxants,
antianaemics, antihistamines, corticosteroids, anitfungals,
vasodilators, tranquillizers, vaccines, antimalarials, birth control
pills and more. We may say that most of the classes of drugs that can
be marketed to consumers were involved.
The WHO Department of Essential Drugs has continued this work and
in 1999, issued a very commendable set of guidelines for the
development of measures to combat the problem. This report took note of
some of the increasingly common ``horror stories'' of the carnage
caused by defective counterfeit products such as deaths of children
resulting from liver damage caused by the inclusion of toxic substances
and unplanned pregnancies resulting from birth control pills containing
no active ingredient.
The reason for their growing availability and popular acceptance,
as noted by WHO executive Dr. Suzuki at the World Health Assembly in
May 2000, is the combination of ``profit and price'', the usually
dynamic of any drug traffic. Pharmaceutical counterfeiters, who do not
have to trouble themselves with producing a quality product, or paying
for any of the expensive research that originally created it, can
concentrate on the authenticity of appearance and still offer a bargain
price. A speaker from the Health Ministry in Benin observed that people
were dying from counterfeit drugs daily, but continued to buy them
because of their relatively cheap price. While visiting Nigeria some
years ago, I found that the usual ``pharmacy'' services were offered on
the street from the trunk of beat-up vehicles where, according to
experts, most of the modern medicines were counterfeits.
WHO reports that although counterfeit pharmaceuticals are extremely
common in developing countries, they have also been found in developed
countries as well. Indeed, the principal consumer interest driving much
of the counterfeit pharmaceutical market along the Mexican border is
also the desire for cheaper medications. Who wants to pay more when you
can pay less? Who wants to pay for another office visit to the doctor
when you can buy the drug that you have been using at a cheaper price
on the other side of the border, and without a prescription!
vii. deficiencies in control and enforcement
Perhaps the greatest service that WHO has rendered is to enumerate
the current massive deficiencies in national and international efforts
to deal with the problem. I think that those of us who work in the area
of controlled drugs are particularly aware of this because of the total
lack of most of the tools, institutions and practices that we regularly
use. I am perhaps especially sensitive to this, having so often
experienced the frustrations of laboring to organize international
enforcement cooperation in the absence of clear and specific legal
authority. This proved to be an excruciating problem in dealing with
the example I gave of Methaqualone which, although the subject of an
extraordinary illicit traffic was not under legal control in most of
the countries that were feeding it. The first attitude is always the
same; ``We don't have an obligation, we don't have the authority, and
we don't have the time.'' Let's look at some of the specifics.
The counterfeiting of pharmaceuticals is a thoroughly international
problem. Production and distribution seldom occurs within a single
country and often involves global commerce. Yet there is no specific
multilateral treaty imposing obligations to criminalize, report, or
cooperate in the suppression of this traffic, nor any international
staff to collect, analyze and disseminate information. This contrasts
sharply with our work in the area of drugs of abuse where we have had
treaties since 1911 and a Board and staff, which monitors their
compliance.
Perhaps of most importance is the fact that, as a result of efforts
that DEA and others have made, a functioning, effective informal
international law enforcement effort has been constructed around these
agreements. The staff of the International Narcotics Control Board is
daily working with the law enforcement agencies of dozens of countries
which all communicate and cooperate together in operations to suppress
illicit diversion of both controlled drugs and chemicals. I assure you
that the results are quite impressive and have had significant impact
on the traffic in a long list of narcotics, stimulants, and depressants
that are often diverted into the illicit traffic, as well as chemicals
for the manufacture of methamphetamine, amphetamine, MDMA, cocaine, and
heroin. This structure does not exist in the area of counterfeit
pharmaceuticals.
Since there is no treaty, there are also no legal obligations to
penalize certain actions, or designated agencies to systematically
collect intelligence or assist each other in investigations. I would
defer to the FDA for an account of the situation in the US, but in most
cases, I doubt that there is specific assignment of clear enforcement
responsibilities and mandate, together with dedicated personnel and
resources. Usually, such laws as exit are of a regulatory nature and
are generally the responsibility of the Health Ministries. The national
law enforcement agency may help out on a selective, ad hoc basis. This
approach is lacking in the advantages that we possess in the area of
controlled drugs and chemicals. In short, on a global level:
<bullet> National laws are often inadequate,
<bullet> International shipments are not searched or verified in free
trade zones,
<bullet> There is a lack of dedicated enforcement personnel and
resources,
<bullet> There is no systematic data base and no requirement for one,
<bullet> There is no specific treaty or set of uniform international
obligations,
<bullet> There is no dedicated staff to monitor compliance, and
<bullet> There is no functioning, systematic international law
enforcement effort.
viii. future challenge of the global economy
The pharmaceutical industry has become an increasingly important
part of health care and is deserving of specific attention, regulation
and protection from crime and corruption. It is clear that there are
strong financial incentives to engage in pharmaceutical counterfeiting.
The level of criminal activity can be expected to increase rapidly with
the globalization of commerce and the emphases on speeding this
commerce through Customs barriers. Moreover, the increasing variety,
effectiveness and elegance of pharmaceutical remedies will also
increase these financial incentives.
The potential damage from this criminal activity is enormous and
includes:
<bullet> Injury to patients whose maladies go untreated because of
reliance upon substandard or entirely bogus counterfeit
preparations,
<bullet> Injury to patients who unwittingly consume counterfeit
preparations containing poisonous ingredients,
<bullet> Damage to the entire public health system by undermining
public confidence in medications and the pharmaceutical
delivery system,
<bullet> Damage to the pharmaceutical industry in terms of lawful
revenues and public confidence, and
<bullet> Provision of additional financial support for crime, violence
and corruption.
I think that in so far as the United States is concerned, we have
thus far been spared most of the consequences of this problem, although
there is ample warning on our southern border of what it will look
like, if unattended. But to protect our people in the future, and to
establish an enforcement regime that will protect all people, we must
invent some things that do not now exist.
Thank you very much for your attention and for this opportunity to
contribute to your valuable work.
Mr. Greenwood. We appreciate your testimony.
Mr. deKieffer.
TESTIMONY OF DONALD deKIEFFER
Mr. deKieffer. Thank you very much, Mr. Chairman. Good
afternoon to the committee. My name is Donald deKieffer and I'm
an attorney here in Washington, DC. I've been practicing
international trade law for around 30 years now. Previously, I
was the General Counsel to the U.S. Trade Representative. In
the last 15 years we've concentrated part of our practice on
international antidiversion and anticounterfeiting. In that
period, we've identified thousands of international
counterfeiters and diverters, including hundreds of individuals
and companies who are selling counterfeit and diverted drugs
right now in the United States.
Today I considered dozens of different issues that are
relevant to these hearings: intellectual property rights, R & D
funding for the next generation of drugs, improvements in
cooperation between various law enforcement agencies in the
effective delivery of drugs to impoverished nations. But rather
than address all those, each one of which might be the subject
of a separate committee hearing, I'd like to talk about three
things. The first is that permitting diverted drugs into the
United States market will destroy the current regulatory
regime. Second, the safety and efficacy of the U.S. drug supply
will be placed in jeopardy. And third, permitting uncontrolled
imports of prescription drugs will not significantly reduce
costs to most consumers, but will enrich unscrupulous, cynical
and even criminal elements.
The purpose of this testimony, I'll define diversion as the
unauthorized transfer of prescription drugs from its intended
recipient to other unauthorized destinations.
Getting back to my first point for a moment, permitting
diverted drugs into the United States market will destroy the
current regulatory system. The U.S. regulatory scheme is built
upon almost a century of solid science and experience designed
to protect Americans from unsafe and unproven drugs. But if
anybody can buy anything from anyone without a prescription,
the entire regulatory regime collapses. Congress may as well
just abolish the FDA.
The second issue is linked to the first. Those who suggest
that the FDA merely become advisory or gold standard agency in
other words, just setting advice with regard to what the
standard should be without any enforcement at all ignore the
clear danger of counterfeits. Well, counterfeits continue to be
a minor problem. They're fast growing in the United States and
they will overwhelm legitimate markets if current regulations
are abolished. There is simply no way for consumers to
distinguish between legitimate and counterfeit goods unlike
going down to K Street and buying a $30 Rolex. There is no way
a consumer can tell a legitimate pharmaceutical from a
counterfeit.
In countries where diverted pharmaceuticals are available,
counterfeits have soon followed, displacing the legitimate
products. Diversion is merely a Trojan horse for counterfeits.
This is not a free trade issue and I really want to
emphasize this. Any foreign manufacturer who meets U.S.
standards can sell legitimate goods in the United States right
now and I don't think anybody wants to change that. But without
regulation counterfeits can wreck even the legitimate import
market.
The third point is that cost of drugs will not
significantly decline for consumers if diverted prescription
drugs are permitted into the United States.
In other areas where diversion is permitted, for example,
in over-the-counter pharmaceuticals and other consumer
products, the prices to consumers are only slightly below
normal retail. It's the middle men who pocket enormous profits.
In South Africa, for example, half of all the pharmaceuticals
dispensed by the South African government itself are stolen.
These goods that are stolen never entered the bloodstreams of
indigent Africans, but rather are sold for huge profits abroad
and in South Africa. The stolen and diverted goods are replaced
in South Africa with counterfeits.
There is no cheap or easy solution to these problems we've
discussed today, but we cannot jeopardize the safety or health
of U.S. consumers by artificial and dangerous gray market
import schemes. We need to have prescription drug coverage for
all those who really need it, rather than jeopardizing the
safety and health of all of us.
We need more effective enforcement, not the abolition of
enforcement. In short, any proposal to permit the unregulated
imports to prescription drugs will destroy the U.S. regulatory
scheme, jeopardize the safety and health of millions of
Americans, and not result in significant cost savings to
American consumers and I thank you and would look forward to
your questions.
[The prepared statement of Donald DeKeiffer follows:]
Prepared Statement of Donald deKieffer, deKieffer & Horgan
introduction
Mr. Chairman and members of the Subcommittee: I appreciate the
opportunity to appear before you. I am Donald deKieffer, attorney at
deKieffer & Horgan in Washington D.C. My firm specializes in the
practice of international regulatory law. I have over thirty years of
experience in trade law and policy development and have worked for more
than a decade in tracking and investigating international diverters.
Today I will testify regarding the diversion and global counterfeiting
of pharmaceutical products. Although many of the clients I represent
are pharmaceutical companies, I am neither speaking on their behalf nor
on behalf of the pharmaceutical industry in general.
The objective of my testimony is to inform this committee of the
existence of an active pharmaceutical diversion trade and to
demonstrate how failure to control this practice opens the door for the
entry of counterfeit drugs into the United States. I will first present
a foundational background on the law regarding drug imports. Secondly,
I will discuss the nature of the diversion problem and its influence on
criminal activity, the pharmaceutical market, and governmental
regulatory agencies, in particular the FDA. Thirdly, I will propose
possible avenues to pursue in the development of solutions to these
problems.
overview
Drug Classifications
Controlled substances are classified into five different schedules.
The schedules are distinguished from each other based on the potential
for drug abuse. Schedule I identifies substances with a high potential
for abuse that do not currently have an accepted medical treatment use
in the United States, such as heroin and marijuana. Schedules II
through V are controlled substances with legitimate medical purposes,
such as Ritalin and Valium. Schedules II through V also include
``lifestyle drugs.'' These substances, such as Viagra, target disorders
affecting the quality of life rather than specific diseases. Lifestyle
drugs are commonly abused prescription substances. Additional
controlled substances, such as OxyContin, which are not lifestyle
drugs, are also abused.
Diversion
International diversion is the importation of products originally
intended for distribution in another country. Pharmaceutical diversion
involves substances classified in schedules II through V. A classic
diversion scheme begins when drugs that are produced in the United
States are either sold at low prices or are given philanthropically to
other countries. Corruption and fraud in the countries of destination
permits third parties to obtain large quantities of U.S. produced drugs
at low costs. These drugs then make their way back into the U.S. market
for resale at going market rates, thus generating large profits for the
diverters.
Closely related to diversion is the practice of parallel importing,
which is the importation of patented drugs by third parties without the
authorization of the patent owner. Drugs produced by U.S.
pharmaceutical companies are available for a lower cost in other
countries where the foreign governments fix pharmaceutical prices.
Diverters purchase these drugs abroad and redistribute them in the U.S.
market, thus undercutting the U.S. market price and making a tremendous
profit.
Another subcategory of diversion is smuggling. While diverted
products re-enter the country under the guise of legal imports,
smuggled drugs are routed into the country through illegal means.
Smuggling is the preferred means of re-importing diverted drugs. These
pharmaceuticals mainly come across customs borders or through the mail
system with fraudulent documentation. The sheer volume of diverted
drugs entering the country prevents customs officials from detecting or
seizing more than a mere fraction of them.
Counterfeiting
Many foreign countries permit the cross border exchange of
imitation patented drugs manufactured in countries other than the
United States. Counterfeit drugs are a tremendous problem in countries
with lax import regulations. Counterfeit pharmaceuticals are often
purchased to replenish the dwindling drug supplies that result from
diversion. These counterfeits are not subject to any form of production
regulation, and once they get mixed into the system they are
essentially indistinguishable from the legitimate product. While
counterfeit drugs are not yet rampant in the United States, the
loosening of import regulations leads to a climate that increases the
potential for counterfeit distribution.
Diversion is a Trojan Horse for counterfeits. Drugs are no longer
part of a regulatory infrastructure once they leave the control of the
originally intended recipient and enter the channels of diversion. Many
of these drugs pass through countries where there is rampant corruption
and fraud in the drug industry, and counterfeits are in abundance.
Because there is no way to monitor where the diverted products have
been or how they have been handled, it is highly likely that
counterfeits will unknowingly be mixed with diverted drugs. Counterfeit
products then enter the U.S. system mixed with legitimately produced
U.S. drugs.
Counterfeiting in the U.S. is already existent to a certain extent.
For example, between 1991 and 1995 the FDA and U.S. Customs officials
seized enough evidence to incriminate Flavine International Inc., a New
Jersey based company, in a counterfeit drug scandal. Flavine bought
bulk amounts of veterinary antibiotic ingredient base and other human
antibiotics from an unapproved source in China for considerably less
than the price of the legitimate products. Flavine then resold the
material to unsuspecting U.S. drug companies at an inflated rate. The
scheme posed a risk to animals and humans because the counterfeit drugs
were of unknown potency and quality. Six patients in Denver suffered
toxic reactions.
More recently, the FDA has been investigating cases of counterfeit
injectable drugs. Instances of counterfeit Serostim, a growth hormone
used by AIDS patients, Nutropin, also a growth hormone, and Neupogen, a
cancer drug, have been detected in the past month.<SUP>1</SUP> FDA
investigations are ongoing and it is not yet clear whether the drugs
were produced in the United States or overseas. At least some of these
products ended up in U.S. pharmacies and were actually distributed to
customers who experienced adverse reactions.<SUP>2</SUP>
---------------------------------------------------------------------------
\1\ Melody Petersen, 3 Fake Drugs Are Found in Pharmacies, N.Y.
Times, June 5, 2001 at http://nytimes.com/2001/06/05/business/
05DRUG.html.
\2\ Douglas Pasternak, Knockoffs on the Pharmacy Shelf: Counterfeit
Drugs are Coming to America, U.S. News, June 6, 2001 at http://
www.usnews.com/usnews/issue/010611/usnews/counter.htm.
---------------------------------------------------------------------------
current regulations and laws regarding drug importation
The federal government has jurisdiction to control pharmaceutical
importation into the United States. The FDA, DEA and U.S. Customs are
the federal agencies primarily responsible for overseeing drug import
regulation.
The law effectively prohibits the importation of any drugs,
including foreign made versions of U.S. approved drugs, that have not
received FDA approval to demonstrate they meet the federal requirements
for safety and effectiveness.<SUP>3</SUP> FDA approved drugs can only
re-enter the country if they are being shipped directly back to the
manufacturer. When customs officials receive a shipment that contains
non-approved pharmaceuticals intended for commercial distribution they
notify the local FDA district, and the FDA assumes responsibility for
deciding whether or not to seize the goods. FDA personnel are also
responsible for monitoring mail importation. Customs officers from the
customs mail division will examine a parcel and set it aside if it
appears to contain a drug that the FDA has specifically requested be
held or an FDA-regulated article that appears to represent a health
fraud or an unknown risk to health.
---------------------------------------------------------------------------
\3\ 21 U.S.C. Sec. 331(d) (2000).
---------------------------------------------------------------------------
The rules governing personal importation of approved drugs from
foreign countries vary slightly. Congress recently stipulated that a
United States resident may import up to fifty dosage units of a
controlled medication without a valid prescription at an international
land border.<SUP>4</SUP> Medications must be declared on arrival, be
for own personal use, and be in their original container. The FDA has
the ability to exercise discretion in the enforcement of this law and
may permit the entry of unapproved drugs under extenuating
circumstances, such as the continued treatment by a foreign doctor.
However, this policy does not apply to foreign-made chemical versions
of drugs available in the U.S. The FDA cannot assure that such products
have been properly manufactured and are effective. Their use would
present an unreasonable risk. Additionally, the FDA reserves the right
to refuse entry or seize any drug it considers unapproved and,
therefore, illegal.<SUP>5</SUP>
---------------------------------------------------------------------------
\4\ 21 U.S.C. Sec. 956 (a) (2000).
\5\ U.S. Customs, Importation of Prescription Medication/Drugs
Consumer Alert, available at http:// www.customs.ustreas.gov/travel/
med.htm.
---------------------------------------------------------------------------
The DEA has recently contributed additional regulations designed to
help control pharmaceutical imports from foreign markets. According to
the DEA, consumers must have valid prescriptions to legally obtain
controlled substances. Consumers cannot legally purchase controlled
substances from foreign Internet sites and have them shipped to the
U.S. unless the consumer is registered with DEA as a controlled
substance importer and acts in compliance with DEA
requirements.<SUP>6</SUP>
---------------------------------------------------------------------------
\6\ Notice, Dispensing and Purchasing Controlled Substances over
the Internet, 66 Fed. Reg. 21,181 (April 27, 2001) available at http://
www.deadiversion.usdoj.gov/fed__regs/notices/2001/fr0427.htm.
---------------------------------------------------------------------------
nature and consequences of pharmaceutical diversion
Promotion of Criminal Conduct
Failure on the part of the U.S. government to control
pharmaceutical diversion encourages criminal behavior both domestically
and internationally. The ease with which pharmaceutical drugs are
smuggled across the border makes diversion enticing as a low-risk
criminal activity with high economic returns. Diverters and
counterfeiters are able to exploit the American public because of
increasing frustration surrounding the high cost of medications and a
market that has been traditionally free from unapproved or dangerous
products. The proliferation of an American gray market, therefore,
invites the theft of American drug products in foreign countries, thus
completing the vicious circle of criminal conduct.
The diversion trade also facilitates the abuse of prescription
drugs in the U.S. An estimated four million citizens in the United
States are addicted to prescription drugs.<SUP>7</SUP> Many of these
products are lifestyle drugs, such as Viagra, weight control products,
or tranquilizers. There is also a serious problem with the misuse of
other legitimate medications. For example, the pharmacological effects
of OxyContin, a central nervous system depressant designed principally
as a pain medication for cancer victims, make it a substitute for
heroin.<SUP>8</SUP> OxyContin overdoses have been the cause of over
forty deaths on the East Coast in the last year.<SUP>9</SUP> Much of
the illegal OxyContin supply comes from diverted sources. Diversion
increases the ability of individuals to receive drugs through improper
channels without a prescription, thus fostering the opportunity for
misuse of these products.
---------------------------------------------------------------------------
\7\ John Smith, A Prescription for Drug Abuse, Wash. Herald, May
20, 2001.
\8\ National Drug Intelligence Center, OxyContin Diversion and
Abuse, (January, 2001), available at http://usdoj.gov/ndic/pubs/651/
overview.htm.
\9\ Id.
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Destruction of the Pharmaceutical Market
Diverters regularly import undetected pharmaceuticals into the
United States. Since 1997, more than 4,600 foreign drug manufacturers
have shipped to the United States without being inspected by the
FDA.<SUP>10</SUP> Additionally, Congress has relaxed the regulations on
the importation of controlled substances by allowing U.S. citizens to
legally import limited amounts of price-controlled drugs from Mexico
and Canada for personal consumption.<SUP>11</SUP> Slackening of import
standards increases the likelihood of diverted drugs devastating the
U.S. pharmaceutical market.
---------------------------------------------------------------------------
\10\ FDA Admits to Lacking Control Over Counterfeit Drug Imports
American Society of Health-System Pharmacists available at http://
www.ashp.com/public/news/breaking/counterfeit.htm.
\11\ 21 U.S.C. Sec. 956 (a) (2000).
---------------------------------------------------------------------------
Diversion, in the form of parallel importing, is a violation of
intellectual property rights. Included in most patents is the exclusive
right to the use, including importation and exportation, of the
patented good. Intellectual property rights are the financial basis of
the pharmaceutical industry. The more diverted and counterfeit drugs
permitted to enter the country, the less control the patent holders
maintain. Taking away the intellectual property rights of the
pharmaceutical industry will render patents meaningless and will create
major financial set backs for the market. Pharmaceutical companies may
have to freeze research and development and may not be able to
financially justify pouring resources into the creation of new and
improved medications.
Diverted drugs destroy the predictability of supply and demand in
the pharmaceutical industry. The U.S. government does not artificially
control drug prices. The U.S. pharmaceutical producers have not
traditionally competed with international drug distributors,
principally for regulatory reasons. The result has been that
pharmaceutical companies have freedom to incidentally set prices for
the products they develop. Consequently, as happens in many different
markets, drug prices are disproportionate to actual production cost.
However, inflated prices are necessary to offset the marketing cost of
the specific product, to finance research and development of new
products, and to subsidize medical assistance to struggling nations. In
a regulated system such as this, the pharmaceutical industry bases
production on predicted market needs. Diverters destroy the market
balance when they enter unknown and unregulated surpluses of any
product into the country through the channels of diversion. Companies
are unable to maintain any sort of meaningful records regarding the
distribution and consumption of drugs and cannot react proportionately
to the market need.
Diverters exploit the price disparities between U.S and foreign
pharmaceutical prices. Pharmaceutical companies provide drugs to other
countries either philanthropically or at much lower prices than they
are sold domestically. Diverters capitalize on this price differential
by obtaining low priced drugs in other countries. They are then able to
undercut the market price when re-selling drugs back in the U.S. This
practice generates a surplus in the American market and prevents
pharmaceutical companies from meeting their projected sales quotas.
Ironically, customers are not the ones financially benefiting from
diverted drug sales. Diverted drug products often barely undercut the
normal retail prices. However, because diverters obtain the drugs at a
fraction of U.S. resale prices, the diverters assume a tremendous
profit while the customers reap only a fractional benefit.
The entrance of diverted drugs and counterfeit products into the
market creates a financial liability for the pharmaceutical industry.
Prescription drugs carry a strict liability for the producers. Strict
liability means that drug companies are completely accountable for
their products and must bear the cost of lawsuits and fines, regardless
of any question of negligence. Counterfeit drugs may easily be mixed
with diverted products. Counterfeit drugs are dangerous because they
are entirely foreign substances masquerading as the genuine product,
and they may not even consist of the same ingredients that they profess
to contain. There is a high likelihood that customers who
unsuspectingly ingest these products may be adversely affected. It is
difficult, even for a professional, to distinguish between
counterfeited and legitimate drugs. Since these counterfeit products
are difficult to distinguish, companies may find themselves liable for
situations that were not of their own causing. The potential financial
hit that the pharmaceutical industry will bear, as a result of
liability, will adversely affect the financial stability of U.S. drug
companies.
Diversion also affects world pharmaceutical markets and finances
criminal conspiracies. Many countries, such as South Africa, Israel,
Russia and the Philippines have open borders with respect to the
importation and exportation of pharmaceutical products. Open border
countries have lost strict regulatory control of their drug markets.
For example, in South Africa over fifty percent of the medication
supplied to the government ends up stolen. Open border countries have
also experienced a corresponding surge in counterfeit medicine entering
under the guise of parallel imports. Frequently, the counterfeits enter
the country as a means of replenishing the drug supply depleted due to
the diversion of the legitimate drugs to more lucrative markets in
Europe and America. Consequently, the medicines intended for a
particular population are not getting to the people that need them; in
their place, false and dangerous counterfeits are being provided, and
criminals reap the financial benefit.
Undermining the FDA
The American public is currently frustrated with high priced
pharmaceuticals. There is an outcry for access to pharmaceutical
products that are cheap, readily available, efficacious, and safe.
However, permitting diversion and parallel imports is not a viable
solution. Safe and efficacious products come at a cost. The entrance of
diverted and counterfeit drugs into the U.S. will destroy drug control
regimes currently in place and the FDA will lose its ability to monitor
and control drug production and distribution in this country.
Increased diversion traffic through inefficient monitoring at the
border will prevent the FDA from controlling drug entry and
distribution. Unchecked pharmaceuticals currently enter the country
through the mail system and across the Mexican border. Due to the sheer
volume, this influx of drugs basically goes unmonitored by federal
regulatory groups such as the FDA. As a result, drugs in this country
are being distributed and sold without proper authorization. This
diminishes the ability of the FDA to control the distribution of drugs.
Citizens are able to access ``lifestyle'' drugs and potentially
addictive substances without prescriptions or the direction of a
physician. Consequently, the FDA is losing its ability to manage
prescription drug use.
Counterfeit drugs present a danger to citizens because the FDA is
unable to monitor the products for quality and safety. Counterfeit
drugs, principally produced in countries such as India, are imitations
of U.S. made products. However, it is impossible to know for certain
what these medications contain, how they were produced, where they were
stored, or the potential side effects of ingestion. By allowing the
diversion trade to persist, the likelihood of distribution of these
potentially lethal medications increases, and the FDA loses the ability
to regulate the quality and safety of products being distributed to the
unsuspecting U.S. public.
Diverted drugs that leave the control of the original distributor
place consumers in jeopardy because the means of shipment and storage
are unregulated. Diverted drugs enter and exit the hands of multiple
unknown parties before they eventually reach a consumer. These drugs
are commonly stolen in bulk from government agencies in foreign
countries and are routed through countries such as Mexico before they
reach consumers in the United States. Most drug products have specific
instructions regarding storage temperature and expiration date. With
diverted drugs, there is no guarantee that the products were properly
handled during shipping and storage. The FDA has always exerted strict
controls on the production and distribution of drugs in the United
States. Consumers have learned to expect pharmacies and drug
distributors to provide safe medications. Allowing diverted drugs into
the country will destroy the FDA's ability to guarantee safety and will
increase the danger to consumers who may unknowingly purchase and
ingest these products.
Counterfeit drugs that enter under the guise of parallel imports
likely come from unapproved locations. Both counterfeit drugs and
diverted drugs are huge risks to the citizens of this country. The FDA
has traditionally been able to approve the production location of drugs
and foreign products. When drugs are smuggled into the country, there
is no way of knowing where they have traveled. Additionally,
counterfeit drugs entering the country through diversion may have been
produced anywhere. The FDA is, therefore, losing its ability to control
and monitor the production sites for pharmaceuticals being imported
into this country.
Diverted drugs may contain incorrect informational material and
directions or may be mislabeled entirely. Medications are, of course,
dangerous when misused and require specific instructions as per their
usage. Divergence from these requirements may prove extremely harmful
and potentially lethal. Diverted goods are often taken from their
original packaging and distributed to many different importers. The
potential is high that drugs may be mislabeled or put into packages
that lack the appropriate informational material. As the diversion
trade increases, the FDA will in turn lose control over the packaging
and instructions accompanying large quantities of drugs in this
country.
Additionally, the diversion trade destroys systems of record
keeping for the U.S. drug industry. With products being illegally
mailed into the country and smuggled across the borders, it is
impossible for the FDA or the drug industry to keep track of what is
currently on the market. This makes it easier for people to obtain
drugs illegally and promotes the abuse of prescription products.
potential solutions
There needs to be better cooperation between the government
agencies in charge of enforcing laws relating to diversion and
counterfeit trade. According to a report issued by the U.S. General
Accounting Office, the efforts of the FDA, DOJ, DEA and Customs do not
always support each other.<SUP>12</SUP> For example, sometimes the FDA
releases packages of drugs detained by Customs in an effort to conserve
resources. These kinds of actions are counterproductive, undermine the
law, and send mixed signals to the individuals involved.<SUP>13</SUP>
Laws have been put in place to control diversion; however, it needs to
be clear who is in charge of enforcement. Efficacious systems of
detection and seizure as well as substantial penalties for abusers must
be implemented and enforced.
---------------------------------------------------------------------------
\12\ U.S. Gen. Accounting Office, Rep. to Cong. Requesters GAO-01-
69, Internet Pharmacies 17 (2000).
\13\ Id.
---------------------------------------------------------------------------
Foreign Internet pharmacies dealing in illegal imports need to be
eliminated. An abundance of Internet pharmacies situated in foreign
countries advertise prescription drugs. These sites do not require
individuals to have a prescription from their doctor in order to obtain
drugs. Although DEA regulations and the Controlled Substances Act allow
individuals to bring limited quantities of controlled substances into
the U.S for personal use, these regulations do not apply to shipments
into the U.S. from foreign Internet pharmacies. It is illegal to
purchase drugs from such sites. These pharmacies are aware that they
are engaging in illegal activity. Many sites explicitly justify their
practice and include instructions on how to avoid having the packages
seized by U.S. Customs. This problem needs to be attacked at the
source. There must be a crack down on foreign Internet pharmacies
dealing in illegal importation.
The government should look for solutions to help support/subsidize
providing affordable prescription drugs for the elderly and others who
are unable to afford necessary medications. The diversion trade seems
to be supported in part by frustrated Americans seeking cheaper drugs.
It is contended that many of these individuals are seniors who are on
tight budgets and cannot afford the medications they require. The
government should consider providing a means-tested subsidization for
U.S. citizens unable to afford the medications they require. Providing
medication to those who are feeding the diversion market will reduce
the demand for smuggled drugs.
Penalties for prescription drug abuse must be increased. It is
currently very difficult to detect prescription drug abuse, and many
people fail to even recognize it as a crime. Harsher penalties may
decrease the demand for diverted pharmaceuticals and naturally cause
that market need to decrease.
Finally, there needs to be cooperation between government agencies
and the pharmaceutical industry in creating better systems for
overseeing philanthropic drug distribution in other countries. Much of
the aid that is sent to struggling countries is well intended. However,
it has been proven time and time again that these countries lack the
infrastructure and integrity to properly distribute the products to the
intended recipients. It is counterproductive to provide mass quantities
of free or low-priced medication to countries that cannot properly
handle or distribute it. Until a more reasonable infrastructure can be
put in place, bulk deliveries of U.S. pharmaceuticals to
underprivileged countries should be severely restricted.
There likewise needs to be a better system of tracking drugs
destined for distressed markets where there is a possibility of
corruption or diversion. There are FDA approved means of marking both
drugs and packaging that would allow customs officials to quickly and
efficiently monitor what crosses the border. Such a system would help
catch diverted products before they entered the market.
conclusion
In summary, drug diversion is a crime. Its occurrence is
increasing. By permitting this practice to continue, the government
will open the way for counterfeit drugs to enter the U.S., foster
criminal conduct both internationally and domestically, harm the
pharmaceutical market, and undermine the regulatory structure of the
FDA. Measures should be taken to recognize and address these issues.
Mr. Greenwood. We thank you. All of you gave excellent
testimony.
The Chair recognizes himself for 5 minutes for questioning.
Let me address a question to Dr. Shepherd. The law of
unintended consequences tells us that when we try to fix
something we usually cause another set of problems. Even though
we will try to minimize that as much as we can, one of the
concerns that will undoubtedly be raised as we try to tighten
the Mexican-U.S. border will be--what about the poor senior
citizen who doesn't have access to prescription drugs in the
United States and goes over to get the legitimate drug for
legitimate purpose and are we going to foreclose that
opportunity?
Can you give a little information on to what extent you
know, obviously, you know a lot about it, who it is that's
going back and forth. Is there, in fact, (a) much in the way of
legitimate seniors going over for legitimate drugs and
acquiring safe products as a result of that, and is there
actually much of a savings when they do that?
Mr. Shepherd. There is a legitimate market for seniors
especially in the Presidio or McCallum, Texas area where they
go across over to Presidio and get it because there's a lot of
snowbirds that come down from the Midwest and New England,
spend their winters down there and they purchase a year's
supply of Mexican drugs and take them back with them, where
they're going. Laredo, we didn't see a lot of seniors in that
market area and Juarez, I'm not quite sure. El Paso area. But
you're right, there is a legitimate market where a lot of
seniors do take advantage of it and do get them.
The question about whether the drugs they buy over there is
safe, I don't know. I don't know if they're buying----
Mr. Greenwood. How about the cost? Is the savings as
significant as we've heard?
Mr. Shepherd. The savings are significant, but it's
product-dependent. It very much varies by each individual
product. Some products in Mexico are more expensive than here.
Some products may be a dime or more or $2 less in Mexico. But
there are some products where it could be 4 or 5 fold
difference in price.
Mr. Greenwood. How do you recommend then that we deal with
that issue, because it's a legitimate one and I am hopeful that
we will be able to provide a prescription drug benefit under
Medicare, but even that won't necessarily solve the problem
because there will still be some----
Mr. Shepherd. That would be my recommendation, if we had a
prescription drug benefit I think that would dry up a lot of
the market. There's another market over there that presents a
bigger issue and that is families who reside on this side of
the border who visit physicians on the other side of the border
where the family is split between both countries. That's a huge
problem. And I was at a conference not too long ago where the
Mexican Blue Cross and Blue Shield was lobbying Texas to
establish health care system that U.S. residents could sign up
for their health care insurance in Mexico and therefore use
Mexican providers and Mexican pharmaceutical products. That
just opens up all kinds of other problems when you think about
it. Obviously, the best way to go would be some kind of
prescription drug benefit for the elderly or the poor or
indigent poor so that you could bring them back and forth, but
it is a problem. Both those populations.
Mr. Greenwood. Let me just question Mr. Trundley if I may
on the counterfeit problem which is a rather different, but
important aspect of this hearing as well. I'm not sure I heard
a lot in the way of recommendations from you. I saw a lot of
parade of horribles that is very worrisome, but what are your
thoughts about how we get a handle on this. How do we prevent
the flooding of the U.S. market with these counterfeit
products?
Mr. Trundley. Well, first of all, Mr. Chairman, you need
strong legislation in place. Robust legislation to deter and
help prevent the incident.
Second point I'd like to make is----
Mr. Greenwood. By that do you mean tough criminal
penalties?
Mr. Trundley. Tough criminal penalties which prevents and
also legislation to prevent the reimportation of goods as well
into the United States. Tough criminal penalties and also to
support the law enforcement effort.
I would like to echo the point made by Jim Christian, my
colleague, it is becoming now more and more essential to have
field operatives in the countries where the problem lies. For
instance, the British government doesn't employ the FDA
equivalent agents abroad. That means, Mr. Chairman and members,
that the only people who are combatting this counterfeit crime
at the point of manufacture are the pharmaceutical companies'
security representatives. That means that we are conducting
inquiries by remote control 12,000 miles away and the sheer
volume and scale of it means that it's becoming more and more
difficult and we're acting on our own with little or no support
from the British or the U.S. governments.
Mr. Greenwood. Mr. deKieffer, the thought that occurred to
me as you were testifying about this situation in Africa, as
the pharmaceutical companies in this country who have I think
rather generously and compassionately decided to provide very
low cost AIDS drugs to the African continent where they're
gravely needed, what's going to happen in terms of diversion?
Are there procedures in place to prevent bad guys from getting
their hands on these drugs, sending them back, reimporting them
to the U.S. at a tremendous profit and then providing bogus
drugs to AIDS people that AIDS patients who will then obviously
get no benefit at best?
Mr. deKieffer. That's a significant danger. In fact, the
security measures that have been taken to date have to be taken
by the companies themselves because of the demonstrated
ineffectiveness of the security measures that have failed
already all over Africa. Some of the philanthropies that have
distributed goods there have also been able to document the
fact that massive amounts of goods that were intended for good
and philanthropic purposes have not wound up where they're
supposed to be, so yes, there's a very great danger that a lot
of the products that are being distributed in Africa will not
remain in Africa and where they will all end up is anybody's
guess, but we do know that substantial amounts of goods that
are currently being distributed in Africa, including probably
the most advanced country in sub-Saharan Africa, South Africa,
never wind up or don't stay there. They wind up in third
markets. And because South Africa is awash in counterfeit drugs
as well, there's a significant chance that some of those
products could wind up in this country as well, perhaps via
Mexico.
Mr. Greenwood. Thank you. The Chair recognizes the
gentleman from Florida for 5 minute.
Mr. Deutsch. Thank you, Mr. Chairman. I think most of you
sat through the testimony prior to this, the other panels. And
I guess one of the questions I have in terms of the issue of
the counterfeit prescription drugs, I don't know the exact
number, no one knows the exact number, but just from our
oversight visit, a large percentage, maybe even up to 90
percent of the literally millions of products being sent by
mail into the United States are prescription drugs, very well
might be from your companies. Now or at least labeled as if
they were from your companies. I guess my question is we're
talking about literally tens of thousands of drugs and we've
seen the labels and again from our perspective, from a naked
eye perspective, we can't tell the difference. Obviously, the
labeling is very effective. Where are those drugs coming from?
The tens of thousands of ones on a daily basis or the thousands
on a daily basis that are coming into the United States via the
mails, who's producing them? Are a majority of them
counterfeit? Are they being produced overseas in facilities of
your companies? Are they gray market overseas? I mean anyone
want to attempt to answer?
Mr. Glover. I'll try to answer that. It's difficult to
answer that question directly. What we have seen is what we do
know is that in March of 2000 and January of about 2000, just
recently as well, there have been substantial actions in Taiwan
of these kinds of factories that we have seen so we know that
that is a location there, so we know that there's a problem
there based on the actions that we've seen so far. The problem
that we have is that it is an international problem and it
takes many forms. It starts out perhaps even as legitimate
product. It's just bulk active. It then maybe moves as was said
to a free trade zone. It's maybe tabletized. It's not really
counterfeit maybe until somebody slaps a label on it that says
it's from Company X when it indeed is not Company X. And then,
of course, there's an enforcement problem for the same reason.
We have the same enforcement problem here that you have say in
the narcotics traffic.
Mr. Deutsch. Let me just interject, we're going to try to
get through 5 minutes of questions, and the Chairman has been
very liberal and I appreciate that on this issue, but what I'm
trying to really get a sense of is that there's no question and
you've shown it by your testimony that there's absolutely,
there are people who are counterfeiting your products. And
illegal enterprises that are doing it. Obviously, they're
making money from it and we're not getting all the enforcement.
But I guess what I'm saying at least this is a component of
this hearing, but the issue what this subcommittee is really
looking at is literally this phenomenon of millions of product
coming into the United States via the mail and some of that
product is at least labeled as your product and I find it not
easy to believe that all of that's counterfeit because if it
was I think you folks would a lot more concerned about it, that
it really is a product of your companies and whether it's
produced overseas, I mean a lot of the product that Novartis
sells in Hong Kong or in Taiwan or in South Africa is
legitimate Novartis product. I would assume the vast majority
of it is Novartis product. I mean Mr. Christian, do you want to
respond to that?
Mr. Christian. Yes, I'd like to make a quick comment. This
is a counterfeit Voltaran ampoule. Last year in Colombia
working with the authorities we seized 6 million of these. That
is 7 or 8 times what is sold in Colombia in a year. We see 6
million. That's not what was made in Colombia. This is what we
caught, 6 million. To answer another part of your question
because we're concerned about counterfeit product. We're
concerned about expired product. I have here a genuine
antibiotic with an expired label. We seized millions of these.
I have here what they did with them. They put them in hot soapy
water and they took the labels off and I have here the labels
that we seized with the product and these go right around, look
just like genuine and they have a new expiration date. So when
those products come in, you have to be concerned yes, about
counterfeit products, but you also have to be concerned about
expired products, adulterated products. We don't have time, but
I have overheads that show pieces of glass and other foreign
material in vials and ampoules.
Mr. Deutsch. Let me try to follow up specifically on that
though, so again, we're really talking about millions of
product coming to the United States and your assessment is that
most of that is effectively fake or inappropriate?
Mr. Christian. No, our assessment is that the potential is
there for in that grouping that you call those millions of
packages coming in at Dulles and JFK and Oakland, that they
will contain a representative sample that is growing of
counterfeit, of expired, of mislabeled, of adulterated product.
There is no doubt.
Now what you're probably looking for is it 5 percent, is it
50 percent? We don't have that number, but we are very, very
confident that the percentage is growing.
Mr. Deutsch. Let me, go ahead, I'm sorry.
Mr. Trundley. I would just like to add to what Mr.
Christian has said that even though the product might be
genuine, even though it might not have met its expire date, we
cannot be certain that it's been stored in the appropriate
conditions. If a particular life saving drug has to be stored
at 5 degrees Centigrade, how do we know unless it's gone
through the legitimate distribution and supply chain that it's
been stored in those conditions and hasn't been left on the
dockside somewhere in Central and South America in baking hot
conditions? And it's then shipped into the United States. It
might be perfectly legitimate and bonafide a product.
Mr. Deutsch. I guess just one final question about this.
It's probably the most visible website sale is for Viagara and
we don't have a representative from Pfizer here today, but is--
what would your assessment be that most of the stuff that is
being sold on the Internet today for Viagara, is that Viagara
or is that something beyond Viagara.
Mr. Christian. I can comment on that. I think that there
are more than 20 pharmaceutical companies making Viagara in
India. Now one of them and because they honor the process
patent, they are allowed to ship to other countries that honor
the process patent which takes in some Middle East, African,
Argentina, Brazil, Uruguay, limited number of countries that
honor the process patent. One of the 20 plus companies that
manufacture Viagara shipped 40 tons in the year 2000 of
Viagara, 40 tons bulk material. Now I can tell you that the
Middle East and sections of Africa and Argentina, Brazil and
Uruguay are not using 40 tons of Viagara and that's only one of
more than 20 companies that shipped in 2000.
Mr. Deutsch. Thank you. Thank you, Mr. Chairman.
Mr. Greenwood. The Chair thanks the gentleman and
recognizes the gentleman from Michigan, Mr. Stupak for 5
minutes.
Mr. Stupak. Thank you, Mr. Chairman. What happens to your
expired products, Mr. Christian or anyone on the panel? If a
product expires, how are they falling in the hands of these
counterfeiters then who are soaking off the label and putting a
new label on there?
Mr. Trundley. Most companies, in fact, I'm sure that all
companies have a policy of returning the expired product to the
companies by the distributors and the companies then destroy
them. The problem lies when the distributors sell them on the
more unscrupulous wholesalers and dealers who may be just using
it as a front to copy the product, to copy the packaging and
design and putting in the counterfeit rubbish inside the
blisters.
Mr. Glover. I'd like to comment on that for a minute.
Mr. Stupak. Sure.
Mr. Glover. A lot of the times you have a situation
internationally. We've had one particular experience
internationally where a company was to destroy product when it
expired. We found out that the product--we ultimately found the
product on the market. We conducted an investigation,
surveillance and what we found was that in this particular
instance, there were two trucks. The truck would take the
product to the dump to be destroyed and it would instead of
going into the dump would be passed on to another company that
brought it out, so there are unscrupulous people out there. We
have processes in place, but sometimes they're avoided.
Mr. Stupak. Dr. Shepherd, could you go back to the
Oxycontin issue we were talking about earlier.
Mr. Shepherd. Right.
Mr. Stupak. Customs seems to know that these vials are
coming in or packages of 50, they're packaged in Mexico and
they're coming across, but DEA did not seem to understand that
today.
Can you elaborate a little bit more on that whole issue
there?
Mr. Shepherd. I really can't talk for why DEA wouldn't know
because I don't work for DEA----
Mr. Stupak. Right.
Mr. Shepherd. But as a researcher in Laredo, I spent 3
months down there collecting data, the only agents I saw down
there were U.S. Customs Agents. I don't know, ever recall
seeing DEA Agents present, but they may have been present.
Mr. Stupak. But it's your testimony is that it really comes
across already packaged in these 50 or less or packages of 50?
Mr. Shepherd. Oxycontin was coming across in a vial of 50.
We saw it.
Mr. Stupak. Were they stopped at the border by Customs
Agents or anything like that?
Mr. Shepherd. When we were collecting the data last month,
they went to the Customs Agent up front who screened the amount
of drugs coming across. Basically, he just asked the person did
you buy any prescription drugs. If the person said no, and this
was the extent of it, the person said no, they were passed on
through. If the person was honest and said yes, they were
referred back over to us where we asked them to fill out a
little questionnaire of the types of drugs and what you
purchased. If the person said yes and the participant, the
Agent indicated they had purchased more than the 50, then we
never saw them. They went back to another room with a Customs
Agent. And at that time the drug was either confiscated by the
Customs or the person was asked to go back across the border
and sell the drug back to the pharmacy which was--it's been a
common practice.
Mr. Stupak. But if I come up to the border I can have 50
pills of just about anything I want, right, as long as I don't
go over that magic number of 50?
Mr. Shepherd. That's right.
Mr. Stupak. Without a prescription? And I can just pass
through.
Mr. Shepherd. Right, but I warn you, you better have a
prescription from a Mexican doc why you're over there because
you'll end up----
Mr. Stupak. But that's not hard to obtain at all, is it?
Mr. Shepherd. No, that's not hard to obtain at all.
Mr. Stupak. Part of the process.
Mr. Shepherd. That's very easy to obtain.
Mr. Stupak. Okay.
Mr. Shepherd. We saw many people bring Valium and Oxycontin
in 50 units at one time.
Mr. Stupak. You indicated earlier that when you did your
research in 1996 most of the things that came across the border
were controlled substances and that the population buying it
were not the senior citizens that we all hear about and we all
want to help out. So what are the implications of these two
findings? Do you have any reason to believe that the situation
has significantly changed from what you found 5 years ago?
Mr. Shepherd. No.
Mr. Stupak. Well, what are you seeing today, same type
situation?
Mr. Shepherd. No. I have no reason to believe the situation
has changed at all. I do--it's because it's so difficult to
check when they come back into the border. The best way to
check it is to stand in a pharmacy in Nuevo Laredo and watch
the people enter and what they're buying. Stand next to a
shopper and you can see the drugs being purchased, but when
they come across, it's so easy to put them in your purse, put
them in your back pocket and say I didn't buy anything and U.S.
Customs will just let you walk on through.
Mr. Stupak. If I may, Mr. Chairman, a couple more questions
here.
To representatives of the drug companies, Ms. Durant of
Customs, I think she was Customs, right, Customs, testified
that Customs' Cyber Smuggler Center is playing a leading role
in trying to crack down on these websites and they talked about
the successful investigation in Thailand and how they closed
down seven on-line pharmacy sites. I really wanted to ask her
seven of how many of the hundreds that are out there from
Thailand.
My question is with all the expertise we have on this
Panel, has the FDA or the DEA ever contacted any of your
companies in saying man, we've got a problem here with drugs
coming through the Internet, mail orders, how would you
approach it, do you have any--have they ever asked for any
assistance or help or requested your input into this issue?
Someone has been banging on them for 2 years to do something.
Mr. Christian. We sometimes work with the Criminal
Investigative Unit of the FDA, but it's a small unit. It was
only founded 8 years ago approximately. To my knowledge, it has
about 125 agents and they're domestically focused. I'm sure all
over the issue that was in the New York Times on Tuesday. It's
a domestic issue. It's internally. However, the threat to the
United States lies internationally and that's why I mentioned
that we need an international focus on this. It's a little late
to throw investigative resources into the issue once the
products are through Customs and within country. We need to be
out there the way DEA is and the other agencies. Fighting to
keep it up, not investigating it after it came in. But of
course, we're talking limited resources, very limited resources
when it comes to and that's one of the agencies that's divided
between regulatory and law enforcement and in that particular
case the regulatory people are the dominant part of that
agency.
Mr. Stupak. But I take it from your answer they never
contacted you and said look, we're having problems with mail
orders through the Internet and we have to do some work here.
Do you have any suggestions, ideas on how we can best combat
this?
I take it the answer is no.
Mr. Christian. In fairness to them they have appeared at
what John Glover referred to the prescription Pharmaceutical
Security Institute, PSI. They have appeared at our meetings.
They have given presentations. We have discussed issues. There
is not daily, weekly or even monthly contact, but that's
because we're concentrating our efforts in Latin America, in
Asia, Eastern Europe, India. They're concentrating their
efforts internally in the United States as far as I can tell.
Mr. Stupak. Right, I agree, but all these websites, if you
look at them, they're not U.S. websites. They may have a Post
Office Box in some city, but when you really look it through,
they're Thailand, Asia, Latin America.
Mr. Christian. Exactly. We're missing that international
focus on this particular criminal problem.
Mr. Stupak. Good. Thank you.
Mr. Greenwood. The Chair recognizes the gentlelady from
Colorado for 5 minutes for questioning.
Ms. DeGette. Thank you, Mr. Chairman. Following up, Dr.
Shepherd, on Congressman Stupak's question, I'm sure you heard
Ms. Nagel's testimony that she was aware of one instance of
this--of the importation of less than 50 units of the Oxycontin
and she knew about, she had heard about three instances that
you talked about in your study. Now you just said here your
researchers found numerous examples. I'm wondering if you can
give me some sense of how much of the Oxycontin you saw being
brought across the border?
Mr. Shepherd. No, I can't give you a sense of it. All I'm
saying is that the way the study was done, the FDA study, when
you ask the person if they purchased a prescription drug, they
say yes or no. If they said no----
Ms. DeGette. They just went across.
Mr. Shepherd. They just went across. I mean if they had
lied and said----
Ms. DeGette. I understand that. But----
Mr. Shepherd. If you go to the stores, you go to the
farmacias and as a consumer over there and you watch the
business, you know darn well and sure that there's more than
that one person buying Oxycontin because you can see it coming
across the counter.
Ms. DeGette. You can see based on what you're seeing sold
in the farmacias on the Mexican side of the border.
Mr. Shepherd. Correct.
Ms. DeGette. Thank you. Let me talk about for a minute
about a drug we talked about quite a bit in this committee last
year and haven't so much lately and that's Rohypnol which, of
course, is the date rape drug. It's my understanding that this
drug is still made in Mexico by Roche. Do you know, is this
drug still available in Mexico?
Mr. Shepherd. It's still available in Mexico by Roche.
Ms. DeGette. Do you have any sense as a researcher how much
of the drug is consumed in Mexico?
Mr. Shepherd. No, I have no idea.
Ms. DeGette. Do you know if it's still coming across the
U.S. border?
Mr. Shepherd. I have no evidence it's coming across the
border.
Ms. DeGette. Have you talked to any of the farmacias down
in Mexico about how much Rohypnol they're selling?
Mr. Shepherd. No, I've never asked.
Ms. DeGette. It might be a good question to ask next time
you go down.
Last question for you, and that is the Texas Commission on
Alcohol and Drug Abuse has found that the practice of allowing
persons to buy controlled substances in Mexico and bring them
back to the U.S. has contributed to Texas' drug abuse problem.
Have you researched that and do you support the Agency's
finding?
Mr. Shepherd. I've never researched that, but I really
support the Agency's finding. Just from following the zip codes
of people declaring the drugs and find out where they're going,
we see, on our campus, we see a resurgence of Ritalin,
especially during exam time when the youngsters want a
stimulant. That's a common source.
Ms. DeGette. Do you know what the implications are of the
Commission's findings?
Mr. Shepherd. No, I do not.
Ms. DeGette. Mr. Chairman, I'd ask unanimous consent to put
the Texas Commission on Alcohol and Drug Abuse Report into the
record.
Mr. Greenwood. Without objection.
Ms. DeGette. Thank you. I'd like to ask a question of our
three pharmacy representatives here, that is, I'm sure, I think
you were all in the audience when Mr. Hubbard of the FDA
testified that they had made a recommendation to Secretary
Thompson that the importation of all drugs should simply be
halted with a very small exception for severe illnesses like
cancer with very, very narrow guidelines. I'm wondering if you
could each tell me whether you support that recommendation.
Dr. Glover?
Mr. Glover. Speaking from a health and safety perspective
only, yes, I support it.
Ms. DeGette. Mr. Christian?
Mr. Christian. Yes. I support it as well. I see the
dangerous that are out there. It's a public health issue.
Ms. DeGette. Mr. Trundley?
Mr. Trundley. I concur. I also support it, but I would like
to go one stage further and say that if you're going to go and
introduce, if you're going to allow companies to import their
products into the United States technology these days does
provide for more advanced counter measures to protect the
product in transit to make sure that it hasn't been tampered
with, the computer chips, satellite tracking, radio frequency,
identification tags affixed to the packaging in the cartons.
These can be put on at the source of manufacture and tracked
throughout their journey into the United States.
Ms. DeGette. Well, I think that that's an interesting point
and would be an important precaution, for example, for the many
legitimate pharmaceuticals that are imported company to
company, but looking at the videotape of the Dulles facility, I
think that it's going to be quite some long time before we can
have safeguards like that for small amounts that are imported
from individuals to individuals and I'm sure you would agree
with me that the public safety would really say we just need to
stop that right now.
Mr. Trundley. I do agree with you, yes. For the
humanitarian cases, then we have to have something, a process
in place.
Ms. DeGette. But it can be very narrowly drawn.
Mr. Trundley. Yes.
Ms. DeGette. Thank you very much, Mr. Chairman.
Mr. Greenwood. The Chair thanks the gentlelady. One final
question from myself that I would address to Mr. deKieffer, Mr.
Haislip and Dr. Glover, anyone else who wants to comment,
specifically on the counterfeit problem.
I think it's clear that we have a sense of what we need to
do about the question of drugs being, coming into this country
by the mail. I think we have a notion of what we need to do on
the Mexican border, but the counterfeit drug problem which is
perhaps the most insidious of all is probably the most
difficult to solve and looking for specific recommendations,
Mr. Trundley has said what we need to do is pass robust
legislation that makes for very severe criminal penalties for
those who are caught and I don't know how often they're caught
and I don't know whether--maybe you could shed some light on
whether these counterfeiters in other countries that are found
as a result of these investigations ever go to jail, but I'd
like to know about that and I'd also like to know about
specific recommendations for legislation.
Mr. deKieffer. I believe as far as legislation or
regulation, as was mentioned just a moment ago there is
certainly now available to the pharmaceutical companies some
rather high tech technology for at least being able to identify
what are legitimate and not legitimate goods. These include all
the way from the microchips that were mentioned a moment ago to
even DNA markers inside actual pills so you can at least
authenticate or track goods. This is a very practical thing
that can be done and it could be done, I think, without
legislation. It could be done by legislation. There are certain
things that all of these companies do right now covertly, in
other words, covert labeling, covert markings and things like
that, but very often those get replicated very quickly,
particular things like holograms. It takes 6 weeks now to have
a hologram counterfeited or less. So as fast as they're able to
put on new security measures, the bad guys figure out how to
replicate them. But that's one of the answers to the
counterfeiting issue. As has been mentioned today, since a lot
of the counterfeiting goes on outside our borders, the thing
that we need to do is be able to identify the counterfeit goods
as they're coming into the country and whether that takes place
offshore or at the border, by the time it gets into the country
and whether that takes place offshore or at the border, by the
time it gets into the country and gets into the distribution
system, it is very, very difficult to do anything about it
because it's going to go through six or seven hands. We saw
this week one company that was mentioned, it's Quality King,
was mentioned in the New York Times article. Quality King was
identified by this very committee in 1978 as one of the largest
drug diverters in the country and now they're handling
counterfeit products.
Here we have a company that's been in business for 25 years
and identified repeatedly by this committee as still doing it
and basically denying that they ever knew that they were
dealing in counterfeit products. It's surprising.
Mr. Haislip. Well, Mr. Chairman, I think we have several
problems and I'll try to be very quick with them. First of all,
generally speaking, there aren't any--there is not any criminal
law enforcement agency in most countries that's targeting that
issue specifically. Therefore, there is not an international
cooperating group that's targeting that activity specifically.
I mean there may be exceptions to that now and then, but by and
large that's the case. The third thing is that we do lack the
international instruments and agreements to attack an
international problem and the last thing I'd mention is that
there's a danger of looking at this recent legislation on
allowing reimportation that we really don't have the apparatus
to detect this kind of counterfeit problem when it's going to
be presented to our front door. I think there's a serious
question there. So those are quick, very quickly some points
that I would make.
Mr. Glover. Yes, I heard a word today a little earlier I
think in the previous panel that I think kind of explains it.
The word holistic. And that pretty much, this is an insidious
international problem and I think from looking at the
legislature, harmonizing, maybe agreements, conventions, those
kids of things, because again, if you look at what happens, we
said the bulk starts say in China and India and when the bulk
starts there, there's no problem with it. When it moves to
other places, then it's not a violation. It only gets to be a
violation as it starts to move in the stream and I say it goes
from legal to civil violations to criminal violations once you
slap a label on it. So that's--this thing is being constantly
transforming, but I say enforcement, strong enforcement. I also
say I think the political will, I talk about that. It's not
this activity is generally not high on everybody's radar
screen, it's not murder, it's not mayhem, it's usually a
resource issue. They just don't have the issues because they're
dealing with more serious problems so I think that's important.
I think also awareness is a part of the problem. Some of the
stuff that I see, I realize it won't deter everybody, but I
think if somebody sees the stuff that we see and some of these
labs that we see and they realize that that's actually the kind
of stuff they're ingesting, I think it may have an impact on a
few people so I just think a broad approach.
Mr. Greenwood. Thank you. Does the gentleman from Florida
wish to----
Mr. Deutsch. Actually, just a housekeeping thing that if we
can leave the record open just to submit some additional
material.
Mr. Greenwood. The record will be kept open. We are blessed
in this country by pharmaceutical products and medicine that
save lives, extend lives, reduce pain and we're very fortunate
indeed. But it's clear from this hearing that the United States
is also awash in drugs that are misused and mislabeled and
adulterated and counterfeited and unprescribed and people are
dying. People are dying in every State of this country as a
result. This committee is going to act. We're going to act
decisively and swiftly with legislation. We're going to expect
a response from the Secretary of Health and Human Services. I
will publicly ask for his responses in the next 60 days on this
matter and you can be sure that the time that you have spent
here with us today will not be wasted. We will not allow the
time that has expired between 1978 to continue. We will act and
we will act decisively. So thank you very much for your
testimony. The hearing is adjourned.
[Whereupon, at 3:23 p.m., the hearing was adjourned.]
The
Committee on Energy and Commerce |