[Federal Register: September 24, 2007 (Volume 72, Number 184)]
[Notices]
[Page 54293-54296]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se07-67]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Andrew Desonia, M.D.; Revocation of Registration
On September 16, 2005, the Acting Deputy Assistant Administrator,
Office of Diversion Control, Drug Enforcement Administration, issued an
Order to Show Cause to Andrew Desonia, M.D. (Respondent), of Knox,
Indiana. The Show Cause Order proposed the revocation of Respondent's
DEA Certificate of Registration, BD4985531, as a practitioner, on the
ground that Respondent's ``continued registration is inconsistent with
the public interest.'' Show Cause Order at 1 (citing 21 U.S.C. 823(f) &
824(a)(4)). The Show Cause Order also proposed to deny any pending
applications for renewal or modification of Respondent's registration.
More specifically, the Show Cause Order alleged that Respondent was
a participant in a scheme run by Mr. Johar Saran, the owner of
Carrington Health System/Infiniti Services Group (CHS/ISG) of
Arlington, Texas. Id. at 5. According to the allegations, CHS/ISG
operated several DEA-registered pharmacies, which obtained their
registrations through sham-nominees and which were used to order large
amounts of highly abused controlled substances from licensed
distributors. Id. The Show Cause Order alleged that the controlled
substances were then diverted to CHS/ISG, where they were used to fill
approximately 3,000 to 4,000 orders per day which had been placed by
persons through various Web sites. Id.
The Show Cause Order further alleged that Respondent ``participated
in [this] scheme by authorizing drug orders under the guise of
practicing medicine.'' Id. The Show Cause Order alleged that Respondent
``did not see the customers, had no prior doctor-patient relationships
with the Internet customers, did not conduct physical exams,'' and did
not ``create or maintain patient records.'' Id. at 5-6. The Show Cause
Order alleged that between October 13, 2004, and January 28, 2005,
Respondent issued twenty-three prescriptions for controlled substances
``to [i]nternet customers in at least 13 different states,'' and that
``in a single day,'' Respondent ``issued ten drug orders to [i]nternet
customers in ten different states.'' Id. at 6.
The Show Cause Order also alleged that a DEA Diversion Investigator
(DI) had gone to a Web site and ordered Bontril (phendimetrazine) by
completing a questionnaire. Id. Subsequently, the DI received the
filled prescription, which had been issued by Respondent and filled by
Tri-Phasic Pharmacy of Arlington, Texas. Id. The Show Cause Order
alleged that Respondent issued the prescription without ``contact[ing]
the [DI]'' and never ``verif[ied] the information supplied'' by the DI.
Id.
Finally, the Show Cause Order alleged that Respondent ``did not
establish legitimate physician-patient relationships with the
[i]nternet customers to whom [he] prescribed controlled substances.''
Id. The Show Cause order thus alleged that Respondent had violated 21
CFR 1306.04.
On or about September 21, 2005, the Show Cause Order was personally
served on Respondent. On October 20, 2005, Respondent, through his
counsel, requested a hearing. The matter was assigned to Administrative
Law Judge (ALJ) Gail Randall, who proceeded to conduct pre-hearing
procedures. The matter was subsequently stayed while Respondent's
counsel attempted to locate a witness.
On December 19, 2006, Respondent's counsel moved to withdraw. As
grounds for the motion, Respondent's counsel established that he had
sent two letters to Respondent by certified mail, which requested that
Respondent contact him to discuss the case. Respondent's counsel
further showed that Respondent had made no attempt to contact him.
Respondent's counsel thus asserted that Respondent had ``cut off all
communication with [him] thus breaching the attorney-client
relationship'' and violating the retainer agreement between them.
Motion to Withdraw at 2. In addition to seeking leave to withdraw,
Respondent's counsel asked the ALJ to grant Respondent thirty days to
find replacement counsel.
Upon receipt of the motion, the ALJ ordered the Government to
respond. On December 28, 2006, the Government filed its response
stating that it did not object to the motion.
On December 29, 2006, the ALJ granted the motion. In her order, the
ALJ also directed Respondent to notify the hearing clerk by January 29,
2007, whether he intended ``to proceed with a hearing.'' Order Granting
Resp. Counsel's Mot. to Withdraw at 3. The ALJ further informed
Respondent that if he failed to file notice of his intention to
proceed, he may be ``deemed to have waived his right to the hearing,''
and that the hearing, which was already scheduled, could be cancelled.
Id. (citing 21 CFR 1301.43(e)). The Order was served on Respondent by
certified mail sent to his last known address.\1\
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\1\ Government counsel had earlier served Respondent with a copy
of a December 19, 2006 Status Report, at the address of 1547 Ohio
Avenue, Anderson, Indiana. In this filing, the Government's counsel
noted that Respondent's counsel had informed her that he intended to
withdraw. The Government also noted its ``position that all
settlement negotiations have failed,'' and that it ``intended to
seek the revocation of Respondent's * * * Registration as proposed
in the September 16, 2005, Order to Show Cause.''
Thereafter, on December 27, 2006, the Government's counsel
received an undated letter from Respondent which appears to have
been written in response to the Status Report.
The Government also served both Respondent's counsel and
Respondent with a copy of its response to the motion to withdraw. In
that filing, the Government made clear that it objected to any
further delays. Moreover, the Government sent its response to
Respondent at two separate addresses, including the one used by
Respondent in his letter which Government counsel had received the
day before.
The ALJ's December 29, 2006 Order, which granted the motion to
withdraw and ordered Respondent to notify the hearing clerk if he
still intended to proceed with a hearing, was served on Respondent
at the 1547 Ohio Ave., Anderson, Indiana. This was the same address
which Government counsel had used to serve the Status Report and
which had elicited a response from Respondent.
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[[Page 54294]]
Respondent did not comply with Order. Accordingly, on February 12,
2007, the Government filed a motion which sought a finding that
Respondent had waived his right to a hearing. The Government also
requested that the ALJ cancel the hearing.
On February 13, 2007, the ALJ granted the Government's motion.
Noting that Respondent had failed to respond to her order, the ALJ
found that ``Respondent has effectively waived his right to a hearing
in this matter.'' Order Granting Gov. Mot. to Cancel Hearing at 1. The
ALJ thus canceled the hearing and ordered that the matter be returned
to the Government for further action.
Thereafter, the investigative file was forwarded to me for final
agency action. Based on his failure to notify the ALJ of his intent to
proceed with the hearing, I conclude that Respondent has waived his
right to a hearing. See 21 CFR 1301.43(d). I therefore enter this Final
Order without a hearing based on relevant material contained in the
investigative file, see id. 1301.43(e), and make the following
findings.
Findings
Respondent is the holder of DEA Certificate of Registration,
BD4985531, which authorizes him to handle schedule II through V
controlled substances as a practitioner at the registered location of
10530 East Division Road, Knox, Indiana. Respondent's registration does
not expire until June 30, 2008.
Respondent came to the attention of DEA during an investigation of
Johar Saran, the owner of a majority stake in Carrington Healthcare
Systems/Infiniti Services Group (CHS/ISG) of Arlington, Texas.
According to the investigative file, CHS/ISG used several Internet
facilitation centers (IFCs) to solicit orders for controlled
substances, which it then dispensed through numerous DEA registered
pharmacies which CHS/ISG controlled. Under the scheme, a person seeking
a controlled substance would go to a Web site, complete a
questionnaire, and request a particular drug. The information would be
forwarded to an IFC, which then sent the information on to a physician
who would review the customer's information and authorize a
prescription.
Thereafter, an employee of CHS/ISG would access the Web site and
download the prescriptions. The prescriptions were then typically
filled by CHS/ISG at its Arlington, Texas facility, and sent to the
purchaser using either FedEx or UPS.
According to the investigative file, the IFCs that serviced CHS/ISG
used at least 59 physicians including Respondent to write controlled
substance prescriptions. According to the file, between October 13,
2004, and January 28, 2005, Respondent wrote twenty-three controlled
substance prescriptions for persons located in thirteen different
states including Alabama, Arizona, California, Georgia, Kansas,
Louisiana, New Jersey, Oklahoma, Pennsylvania, South Carolina, and
Texas. The prescriptions were for phentermine (12 Rxs), Adipex (5 Rxs),
Didrex (4 Rxs), Bontril SR (1 Rx) and phendimetrazine (1 Rx). Most of
the prescriptions were filled by Tri-Phasic Pharmacy of Arlington,
Texas, an entity which was controlled by Saran.
Moreover, on January 19, 2005, Respondent wrote controlled
substance prescriptions for persons located in ten different states
including Kansas, Louisiana, Kentucky, Ohio, Arkansas, Georgia,
California, Pennsylvania, and Alabama. The drugs prescribed were
phentermine (37.5 mg), Adipex (37.5 mg), and Didrex (50 mg). Each of
the prescriptions was filled by the Tri-Phasic Pharmacy.
The investigative file further revealed that on November 15, 2004,
two DEA Diversion Investigators (DIs) visited the Web site,
GiantRx.com, and using a fictitious name, made an undercover buy of 90
phendimetrazine (105 mg.) tablets. After the DIs provided a name and
billing/shipping information, they were required to complete a
``Medical History Form.'' This form required the customer to indicate
her height, weight, date of birth, sex, and whether she smoked. The
form also asked the customer whether she had a physical exam within the
last year, whether any diseases ran in her family, whether she was
taking any other drugs, whether she was allergic to any medications,
and to list any medical conditions she was being treated for and to
provide her surgical history.
The form also asked several ``Phendimetrazine Specific Questions.''
These included whether the customer agreed not to take any over-the-
counter medicine while taking the drug, to certify that she had a Body
Mass Index of at least 25, and to monitor her blood pressure every 14
days and discontinue use of the drug if it exceeded 140/90.
Upon completion of the form and submission of payment information,
the DIs received an e-mail from GiantRx.com indicating that the order
had ``been submitted to a physician for approval'' and that an e-mail
would be sent ``as soon as the doctor has reviewed [your] order.'' The
e-mail further stated that ``[t]he doctor may contact you if he/she has
any further questions.''
On November 29, 2004, the DIs received a package which contained 90
tablets of phendimetrazine (105 mg). The label indicated that
Respondent was the prescribing physician and that Tri-Phasic Pharmacy
of Arlington, Texas, was the dispensing pharmacy. Respondent did not
perform a physical examination on the ``patient'' before issuing the
prescription and there was no contact of any sort between Respondent
and the DIs.
On September 21, 2005, two DIs and a Special Agent interviewed
Respondent at his registered location. During the interview, Respondent
admitted that he reviewed questionnaires submitted to Internet sites by
persons requesting controlled substances used for weight control
purposes. Respondent stated that he would issue a prescription provided
the questionnaire was complete, the person had indicated that he/she
was between the ages of 27 and 45, and the person had a suitable Body
Mass Index. Respondent further maintained that he rejected
approximately twenty percent of the requests because the questionnaires
were not complete.
Respondent admitted to the investigators that he had been involved
in Internet prescribing through two different Internet sites for
approximately 13 months at the time of the interview. Respondent
further admitted that during his involvement with Internet prescribing,
he had approved thousands of prescriptions. Respondent stated that he
received on average fifty questionnaires a day and had received as few
as four per day and as many as one hundred a day to review. Respondent
further told the investigators that while initially he had also
prescribed opiates, he eventually decided to stop doing so and would
approve only prescriptions for weight loss drugs and Viagra (a non-
controlled drug).
[[Page 54295]]
Respondent admitted that he really did not know if the persons
requesting the controlled substances were providing truthful
information on their questionnaires. Respondent asserted, however, that
the situation was not much different than in-person encounters because
patients often lie. Respondent further admitted that he had not
established a doctor-patient relationship with the persons who had
requested controlled substances through the Internet sites.
Discussion
Section 304(a) of the Controlled Substances Act provides that a
registration to ``dispense a controlled substance * * * may be
suspended or revoked by the Attorney General upon a finding that the
registrant * * * has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C.
824(a)(4). In making the public interest determination, the Act
requires the consideration of the following factors:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id.
``[T]hese factors are * * * considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or
a combination of factors, and may give each factor the weight [I]
deem[] appropriate in determining whether a registration should be
revoked.'' Id. Moreover, I am ``not required to make findings as to all
of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see
also Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005).
In this case, I conclude that Factors Two and Four establish that
allowing Respondent to continue to dispense controlled substances would
be inconsistent with the public interest. Accordingly, I will order
that Respondent's registration be revoked and that any pending renewal
application be denied.
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Laws
The central issue in this case is whether the prescriptions
Respondent issued through Web sites associated with CHS/ISG complied
with Federal law. As explained below, the evidence conclusively
demonstrates that Respondent repeatedly violated Federal law by issuing
numerous prescriptions for controlled substances without establishing a
valid doctor-patient relationship with the customers and which lacked a
legitimate medical purpose.
Under DEA regulations, a prescription for a controlled substance is
not ``effective'' unless it is ``issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of his
professional practice.'' 21 CFR 1306.04(a). This regulation further
provides that ``an order purporting to be a prescription issued not in
the usual course of professional treatment * * * is not a prescription
within the meaning and intent of [21 U.S.C. 829] and * * * the person
issuing it, shall be subject to the penalties provided for violations
of the provisions of law related to controlled substances.'' Id. As the
Supreme Court recently explained, ``the prescription requirement * * *
ensures patients use controlled substances under the supervision of a
doctor so as to prevent addiction and recreational abuse. As a
corollary, [it] also bars doctors from peddling to patients who crave
the drugs for those prohibited uses.'' Gonzales v. Oregon, 126 S.Ct.
904, 925 (2006) (citing United States v. Moore, 423 U.S. 122, 135
(1975)).
It is fundamental that a practitioner must establish a bonafide
doctor-patient relationship in order to be acting ``in the usual course
of * * * professional practice'' and to issue a prescription for a
``legitimate medical purpose.'' 21 CFR 1306.04(a); see also Moore, 423
U.S. 141-43. Under existing professional standards, to establish a
bonafide doctor-patient relationship, a ``physician shall'':
i. Obtain a reliable medical history and perform a physical
examination of the patient, adequate to establish the diagnosis for
which the drug is being prescribed and to identify underlying
conditions and/or contraindications to the treatment recommended/
provided; ii. have sufficient dialogue with the patient regarding
treatment options and the risks and benefits of treatment(s); iii.
as appropriate, follow up with the patient to assess the therapeutic
outcome; iv. maintain a contemporaneous medical record that is
readily available to the patient and * * * to his * * * other health
care professionals; and v. include the electronic prescription
information as part of the patient medical record.
American Medical Association, Guidance for Physicians on Internet
Prescribing; see also William R. Lockridge, 71 FR 77791, 77798 (2006).
To similar effect are the guidelines issued by the Federation of
State Medical Boards of the United States, Inc. See Model Guidelines
for the Appropriate Use of the Internet in Medical Practice. According
to the Guidelines, ``[t]reatment and consultation recommendations made
in an online setting, including issuing a prescription via electronic
means, will be held to the same standards of appropriate practice as
those in traditional (face-to-face) settings. Treatment, including
issuing a prescription, based solely on an online questionnaire or
consultation does not constitute an acceptable standard of care.'' Id.
at 4 (emphasis added). Cf. DEA, Dispensing and Purchasing Controlled
Substances over the Internet, 66 FR 21181, 21183 (2001) (guidance
document) (``Completing a questionnaire that is then reviewed by a
doctor hired by the Internet pharmacy could not be considered the basis
for a doctor/patient relationship.'').
Consistent with these standards, the State of Indiana has
promulgated an administrative rule which provides that ``[t]reatment,
including issuing a prescription, based solely on an on-line
questionnaire or consultation is prohibited.'' 844 IAC 5-3-3. Indiana
has promulgated an additional rule entitled: ``Prescribing to Persons
Not Seen by the Physician.'' This rule provides:
Except in institutional settings, on-call situations, cross-
coverage situations, and situations involving advanced practical
nurses with prescription authority practicing in accordance with
standard care arrangements * * * a physician shall not prescribe,
dispense, or otherwise provide, or cause to be provided, any
controlled substance to a person who the physician has never
physically examined and diagnosed.
844 IAC 5-4-1.
As found above, the evidence establishes that Respondent issued
numerous prescriptions to persons he never physically examined and
diagnosed. Rather, Respondent issued the prescriptions based solely on
the questionnaires the customers had submitted. In issuing the
prescriptions, Respondent violated not only existing professional
standards, but also, Indiana law.
Moreover, because Respondent failed to establish a valid doctor-
patient relationship with the persons he issued
[[Page 54296]]
controlled substance prescriptions for, he was not acting ``in the
usual course of * * * professional practice,'' and the prescriptions
were not ``issued for a legitimate medical purpose.'' 21 CFR
1306.04(a). Respondent thus also repeatedly violated Federal law. See
Moore, 423 U.S. at 141-43.
As recognized in Lockridge and other agency orders, `` `[le]gally
there is absolutely no difference between the sale of an illicit drug
on the street and the illicit dispensing of a licit drug by means of a
physician's prescription.' '' 71 FR at 77800 (quoting Mario Avello,
M.D., 70 FR 11695, 11697 (2005)). See also Floyd A. Santner, M.D., 55
FR 37581 (1990). In short, Respondent's involvement in this scheme did
not constitute the legitimate practice of medicine, but rather, drug
dealing.
Accordingly, Respondent's experience in dispensing controlled
substances and his record of compliance with applicable laws makes
plain that his continued registration would ``be inconsistent with the
public interest.'' 21 U.S.C. 824(a)(4). Moreover, because Respondent's
prescribing practices create an extraordinary threat to public health
and safety, see, e.g., Lockridge, 71 FR at 77798-99 \2\; and it is
unclear whether he has ceased engaging in them, I further conclude that
this Order shall be effective immediately.
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\2\ See also National Center on Addiction and Substance Abuse,
``You've Got Drugs!'' Prescription Drug Pushers on the Internet 6
(Feb. 2004) (diversion of controlled substances through the Internet
``threatens the health and safety of millions of Americans--
including our children''); National Institute on Drug Abuse,
Community Drug Alert Bulletin, Prescription Drugs (Aug. 2005).
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a), as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA
Certificate Registration, BD4985531, issued to Andrew Desonia, M.D.,
be, and it hereby is, revoked. I further order that any pending
application of Respondent for renewal of his registration be, and it
hereby is, denied. This order is effective immediately.
Dated: September 14, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-18775 Filed 9-21-07; 8:45 am]
BILLING CODE 4410-09-P