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Andrew Desonia, M.D.; Revocation of Registration
FR Doc E7-18775 [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]
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
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