Remarks as prepared; not a transcript
Vice Admiral Richard H. Carmona, M.D., M.P.H, FACS
United States Surgeon General
U.S. Department of Health and Human Services
Task Force on Drug Importation Listening Session #1: Consumer
Groups
Rockville, Maryland
Friday, March 19, 2004
"Welcoming Remarks"
Thank you all for being here. I am Dr. Richard Carmona, the U.S. Surgeon
General.
I would like to welcome you all to the first listening session of the Task
Force on Drug Importation. On behalf of Secretary Thompson, I want to thank the
members of the task force for your willingness to work on this important issue.
Secretary Thompson formed this task force to explore how drug importation
might be conducted safely and its potential impact on the health of American
patients, medical costs, and the development of new medicines.
I want to thank the Secretary for the opportunity to serve as chair of this
task force. Prescription drug safety is an important public health issue, and I
look forward to working with all of you as we conduct an objective evaluation
based on scientific evidence.
As a trauma surgeon, the former CEO of a health system, and now doctor to the
American people, I understand the critical role that prescription drugs have in
our public health system. The miracles of modern medicine are often found in a
pill. It’s truly wonderful that science has brought us medications that can
unclog arteries, lower blood pressure, cure infection, and save and enhance
life.
Millions of Americans have come to depend on prescription drugs to keep them
healthy. The biomedical research that has led to the development of these drugs
is truly awesome.
The new bipartisan Medicare law marks a historic step to lower seniors’ costs
for their prescription drugs — actually providing them with health care coverage
for these medicines.
Yet we all recognize the interest in other possible ways we can lower the
cost of prescription drugs for those who need them, including importation. That
is the reason for this task force and these listening sessions.
A good place to begin our work is with some background on the law regarding
drug importation. Drug importation is illegal in the United States. On April 22,
1988, President Reagan signed the Prescription Drug Manufacturing Act to ensure
that prescription drug products on sale here in the United States would be safe
and effective, while avoiding an unacceptable risk that counterfeit,
adulterated, misbranded, subpotent, or expired drugs would have on the American
public.
Congress decided that legislation was necessary because there were
insufficient safeguards in the prescription drug distribution system to prevent
the introduction and retail sale of substandard, ineffective, or counterfeit
drugs. Congress also determined that a wholesale drug diversion submarket had
developed that prevented effective control over, or even routine knowledge of,
the true sources of the medications.
Each subsequent administration has reviewed the potential drug importation
process and determined that there is no means to import prescription drugs into
the United States that adequately protects the health of the American people.
In fact, in December 2000, Secretary Shalala sent a letter to President
Clinton that said that the drug importation law passed by Congress in October of
that year, "could pose unnecessary public health risks." Consequently, that
administration was unable to permit the sale of imported drugs.
The current administration has also been unable to certify the safety of
imported drugs, having found disturbing evidence of unsafe drugs from other
countries making their way into American consumers’ homes.
As recently as this January, the Food and Drug Administration and the U.S.
Customs and Border Protection reported their examination of 1,982 parcels that
appeared to contain drug products. They found 1,728 unapproved drugs, including
so-called "foreign versions" of FDA-approved drugs, recalled drugs, drugs
requiring special storage conditions, mislabeled drugs, and drugs containing
addictive controlled substances. Inspectors found that from 70 to 90 percent of
these parcels that they examined in 2003 contained illegal, unapproved drugs.
The negative effects of these unsafe drugs are not always apparent. For
example, if a patient has a heart condition and takes mislabeled or subpotent
prescription drugs, his death isn’t attributed to the poor medication, it may be
attributed to just his heart condition. To date, we know of no way to track the
full impact that faulty imported drugs has had on the health of our citizens.
But common sense tells us that if people are taking mislabeled, inaccurate, or
subpotent medications, there is a clear risk to their health.
What the American people must understand is that the U.S. government cannot
ensure the safety and efficacy of medicines that are purchased through this
current clandestine system. Purchasing and using prescription drugs that are not
produced and distributed under the strict safety guidelines of the FDA is a
potential threat to Americans’ health and well-being.
So can importation be done in a safe and effective manner? The foundation of
this task force’s work will focus on safety and public health issues of drug
importation.
We will research and explore whether prescription drug importation can be
done safely and effectively. And if so, what resources are needed to do so. For
our work to be valuable to the American people, we must determine whether there
is a safe structure for prescription drug importation.
In fact, the Medicare Prescription Drug, Improvement and Modernization Act of
2003 requires us at a minimum to address the following:
- Identify the limitations, including limitations in resources and in
current legal authorities, that may inhibit the Secretary’s ability to
certify the safety of imported drugs.
- Assess the pharmaceutical distribution chain and the need for, and
feasibility of, modifications in order to assure the safety of imported
products.
- Analyze whether anti-counterfeiting technologies could improve the safety
of products in the domestic market as well as those products that may be
imported.
- Estimate the costs borne by entities within the distribution chain to
utilize such anti-counterfeiting technologies.
- Assess the scope, volume and safety of unapproved drugs, including
controlled substances, entering the United States via mail shipment.
- Determine the extent to which foreign health agencies are willing and
able to ensure the safety of drugs being exported from their countries to
the U.S.
- Assess the potential short- and long-term impacts on drug prices and
prices for consumers associated with importing drugs from Canada and other
countries.
- Assess the impact on drug research and development, and the associated
impact on consumers and patients, if importation were permitted.
- Estimate agency resources, including additional field personnel, needed
to adequately inspect the current amount of pharmaceuticals entering the
country.
- Identify the liability protections, if any, that should be in place if
importation is permitted for entities within the pharmaceutical distribution
chain.
and
- Identify ways in which importation could violate U.S. and international
intellectual property rights and describe the additional legal protections
and agency resources that would be needed to protect those rights.
Undoubtedly there will be challenges in our endeavor. In fact, today we start
with many more questions than we have answers. We start with more beliefs
about what is possible than facts about what is possible. I’m hopeful
that some of the answers — or leads on answers — will come from our presenters
today and in the meetings that follow.
I promise to all of the presenters today and in the future listening
sessions, the opportunity to be heard. I expect this process to be completely
transparent, with frank, open, and honest discussion about the health
implications of drug importation.
I also know that there will be diverse ideas presented, and I ask everyone to
be respectful of that diversity.
Let me be clear: the mission of this task force, and the purpose of these
listening sessions, is not to debate drug importation. Those debates are the
purview of Congress.
The role of the Surgeon General is to promote and protect the health of the
American people, and to take the best scientific information and present it in a
clear and understandable way to the American public and our leadership.
Accordingly, this task force is about the facts and the science. And we will
go as far as the facts and the science lead us.
I thank everyone, in advance, for keeping this in mind. These listening
sessions will be conducted in an organized manner, in an effort to produce the
best information possible.
Each presenter will have up to 5 minutes for opening remarks. After all
presenters on a panel have concluded their opening remarks, the task force
members may follow up with some questions.
I ask each presenter to be mindful of the time that so that we can ensure
that everyone has an equal opportunity to be heard. In addition, the task force
will welcome all written and supporting materials that parties would like to
submit.
That information, along with the transcript of each listening session, will
be available to the public.
Today is the first of six listening sessions, including an April 14 session
open to the public. In addition to the listening sessions, the task force and
the Department will engage in our own research on the safety of importation. We
will present the evidence and information we have gathered through all means to
Secretary Thompson and other policymakers for their review and ultimate
decision.
I recognize that the eyes of the nation are on this task force and it is my
goal and duty to ensure that these meetings are conducted in a manner in which
our findings, based on the best scientific evidence, will inspire the full faith
and confidence of the American people.
So without further ado, let’s roll up our sleeves and go to work. I would
like to introduce and welcome our task force members.
- Mr. Ahern, assistant commissioner in the Office of Field Operations, U.S.
Customs and Border Protection, Department of Homeland Security;
- Mr. Azar, HHS general counsel;
- Dr. Carbonell, HHS assistant secretary for aging;
- Dr. Crawford, FDA deputy commissioner;
- Dr. Duke, administrator of HHS’ Health Resources Services Administration;
- Dr. McClellan, incoming administrator for HHS’ Centers for Medicare &
Medicaid Services;
- Mr. O’Grady, HHS assistant secretary for planning and evaluation;
- Mr. Raub, HHS deputy assistant secretary for public health emergency
preparedness;
- Mr. Reilly, public health branch chief at the White House Office of
Management and Budget;
- Mr. Sachdev, acting FDA deputy commissioner for policy;
- Ms. Willis, chief of the Drug Operations Section, Office of Diversion
Control, U.S. Drug Enforcement Administration;
and
- Ms. Winston, trial attorney at the Department of Justice.
Thank you all for your service on this important task force.
Now, let’s begin with our first panel of presenters.
###
Last revised: January 9, 2007
|