[Federal Register Volume 78, Number 92 (Monday, May 13, 2013)]
[Notices]
[Pages 27997-28000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11268]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Leo A. Farmer, M.D.; Decision and Order

    On July 12, 2011, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Leo A. Farmer, M.D. (Applicant), of Baton Rouge, 
Louisiana. The Show Cause Order proposed the denial of Applicant's 
application for a DEA Certificate of Registration as a practitioner on 
the ground that his ``registration would be inconsistent with the 
public interest.'' GX 2, at 1 (citing 21 U.S.C. 823(f)).
    The Show Cause Order specifically alleged that Applicant had 
previously held a practitioner's registration, which had expired on 
March 31, 2010, and that ``[f]rom April 1 to November 5, 2010, [he had] 
authorized 3,497 controlled substances prescriptions'' for various 
schedule III and IV controlled substances including phentermine, 
diethylpropion, and phendimetrazine. Id. at 1-2. The Show Cause Order 
further alleged that because his registration had expired, Applicant 
violated 21 U.S.C. 841(a)(1) and 843(a)(2), as well as 21 CFR 1306.03. 
Id. at 1.
    Next, the Show Cause Order alleged that on August 18, 2010, 
Applicant had issued prescriptions for Adipex-P 37.5mg, a schedule IV 
controlled substance, to two confidential sources. Id. at 2. The Show 
Cause Order alleged that Applicant had acted outside of the usual 
course of professional practice and lacked a legitimate medical purpose 
because each of the two confidential sources did not have a Body Mass 
Index (BMI) which met ``the medically recognized criteria for [being] 
`overweight' or `obese.' '' Id. (citing 21 U.S.C. 841(a)(1) and 21 CFR 
1306.04). With respect to the first confidential source, the Order 
further alleged that his/her BMI was 17.4 and that the source had said 
that ``he/she was not interested in weight loss, merely weight 
maintenance.'' Id.
    The Show Cause Order also notified Applicant of his right to either 
request a hearing on the allegations or to submit a written statement 
in lieu of a hearing, the procedures for electing either option, and 
the consequences of failing to do either. Id. at 2-3. On July 15, 2011, 
the Government accomplished service by Certified Mail addressed to him 
at the address he listed on his application. GX 3. Since the date of 
service of the Order, thirty days have now passed and neither 
Applicant, nor any one purporting to represent him, has filed a request 
for a hearing or submitted a written statement in lieu of a hearing. I 
therefore find that Applicant has waived his right to a hearing or to 
submit a written statement in lieu of a hearing and issue this Decision 
and Final Order based on relevant evidence contained in the record 
submitted by the Government. 21 CFR 1301.43(d) & (e). I make the 
following findings.

Findings

    Applicant is a physician who practices at a clinic in Baton Rouge, 
Louisiana. GX 7, at 1. Applicant previously held a DEA Certificate of 
Registration as a practitioner; however, on March 31, 2010, Applicant 
allowed his registration to expire. GX 4. Applicant did not file an 
application for a new DEA registration until October 5, 2010. Id.
    According to the affidavit of a DEA Task Force Officer (TFO), 
Applicant came to the attention of the Agency during the investigation 
of a person who was suspected of obtaining controlled substances 
through fraud. GX 7, at 1. According to the TFO, between August 2009 
and April 2010, this person went to Applicant's clinic eight times and 
``[o]n seven of those occasions . . . was prescribed weight-loss 
medications despite clear indications that she was not in need of the 
medications.'' Id. However, when on the eighth occasion, clinic 
personnel, who had determined that this person was also obtaining 
prescriptions for weight loss drugs from another physician, confronted 
her with this information, she fled ``and never returned.'' Id.
    Subsequently, on August 18, 2011, two confidential sources 
(hereinafter, CS1 and CS2) conducted undercover visits at Applicant's 
clinic during which they wore recording devices. Id. at 2. According to 
the TFO's affidavit, Applicant asked CS1: `` `[w]hy are you so skinny?' 
'' Id. CS1 told Applicant that ``he/she did not wish to lose weight, 
but just to maintain his/her current weight.'' Id. After noting that 
his clinic was primarily for weight loss, Applicant stated, ``but I 
guess we can handle

[[Page 27998]]

maintenance.'' Id. Applicant issued CS1 a prescription for Adipex-P 
35mg tablets. Id.
    In his affidavit the TFO further stated that ``CS1 is 5'7'' tall, 
weighs 111 pounds and has a BMI of 17.4.'' Id. The TFO also asserted 
that ``CS1 does not meet the generally recognized criteria as 
overweight or obese and is, in fact, underweight according to her 
BMI.'' Id.
    As for CS2's visit, according to the TFO's affidavit, Applicant 
told him/her that his/her weight was normal and asked ``why he/she 
believed he/she [wa]s overweight?'' Id. CS2 told applicant that ``he/
she wanted to lose weight around his/her stomach.'' Id. Again according 
to the TFO, Applicant told CS2 ``that losing five pounds would not do 
much good and weight loss would not be targeted at a specific area of 
the body.'' Id. Applicant issued CS2 a prescription for Adipex-P 35mg. 
Id. at 3.
    According to the TFO, ``CS2 is 4'11'' tall, weighs 104 pounds and 
has a BMI of 21.'' Id. at 2. The TFO further asserted that ``CS2 does 
not meet the generally recognized criteria as overweight or obese.'' 
Id. at 2-3.\1\
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    \1\ In his affidavit, the TFO further stated that ``[a]ccording 
to guidelines published by the American Medical Association, the 
U.S. Department of Health and Human Services, the Centers for 
Disease Control, the National Institute for Health [sic], the 
National Heart, Lung and Blood Institute and the North American 
Association for the Study of Obesity, pharmacotherapy should be used 
on patients with a Body Mass Index (BMI) over 30 or with a BMI over 
27 when certain risk factors for disease or concomitant obesity 
exist.'' GX 7, at 2.
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    During the course of the investigation, a DEA Diversion 
Investigator (DI) also determined that Applicant had allowed his 
registration to expire on March 31, 2010. Affidavit of DI, at 1. 
According to the DI, the Louisiana Board of Pharmacy has granted DEA 
access to its Prescription Monitoring Program (PMP) database through a 
dedicated computer located in a different office. Id. at 2. The DI then 
requested that a DI with access to the PMP obtain a printout of the 
prescriptions issued by Applicant between March 1 and November 20, 
2010; a copy of the printout was submitted as part of the record as GX 
5. Id.
    According to the DI, the PMP data show ``that from April 1, 2010 
until November 5, 2010, [Applicant] issued 3,497 prescriptions for 
controlled substances.'' Id. However, as found above, Applicant had 
allowed his registration to expire on March 31, 2010. The PMP data show 
that Applicant prescribed such drugs as diethylpropion, phentermine, 
Adipex-P (also phentermine), each of which is a schedule IV stimulant, 
as well as phendimetrazine, a schedule III stimulant. See GX 5; see 
also 21 CFR 1308.13(b), 1308.14(e).

Discussion

    Section 303(f) of the Controlled Substances Act (CSA) provides that 
an application for a practitioner's registration may be denied upon a 
determination ``that the issuance of such registration would be 
inconsistent with the public interest.'' 21 U.S.C. 823(f). In making 
the public interest determination in the case of a practitioner, 
Congress directed that the following factors be considered:

    (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, 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 * * * to deny an application. 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) (citing 
Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005)).
    In this matter, while I have considered all of the factors,\2\ I 
conclude that the Government's evidence with respect to Applicant's 
experience in dispensing controlled substances (factor two) and his 
compliance with applicable laws related to controlled substances 
(factor four) establishes that issuing a registration to Applicant 
``would be inconsistent with the public interest.'' 21 U.S.C. 823(f). 
Accordingly, the application will be denied.
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    \2\ The Government produced no evidence (other than Applicant's 
application for a DEA registration) regarding his state licensure 
status; this document suggests that he possessed a Louisiana medical 
license at the time he submitted his application. GX 1, at 1. It 
also produced no evidence as to whether he has been convicted of an 
offense related to the distribution or dispensing of controlled 
substances. However, even assuming that Applicant currently holds a 
valid state license which authorizes him to dispense controlled 
substances, this factor is not dispositive of the public interest 
determination ``because the DEA has [a] separate oversight 
responsibility with respect to controlled substances.'' MacKay v. 
DEA, 2011 WL 6739420, *9 (10th Cir. Dec. 23, 2011). So too, even 
assuming that Applicant has not been convicted of a felony related 
to the distribution or dispensing of controlled substances, this is 
not dispositive because there are multiple reasons why a person many 
not have been convicted (or even prosecuted) for such an offense. 
Id.
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Factors Two and Four--The Applicant's Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances

    As noted above, in the Show Cause Order, the Government alleges two 
separate bases for concluding that Applicant's registration would be 
inconsistent with the public interest. First, it alleges that 
Respondent violated the CSA by prescribing controlled substances 
without a DEA registration. Second, it alleges that Respondent acted 
outside of the usual course of professional practice and lacked a 
legitimate medical purpose when he prescribed Adipex-P (phentermine) to 
the two CSs. I address the latter contention first.
    Under a longstanding DEA regulation, 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.; see also 21 U.S.C. 802(10) (defining the term 
``dispense'' as meaning ``to deliver a controlled substance to an 
ultimate user by, or pursuant to the lawful order of, a practitioner, 
including the prescribing and administering of a controlled 
substance'') (emphasis added); see also La. Rev. Stat. Ann. Sec.  
40:961(33) (2008); \3\ La. Rev. Stat. Ann. Sec.  40:1238.2(A) 
(2008).\4\
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    \3\ Louisiana law defines the term ``prescription'' to mean ``a 
written request for a drug . . . issued by a licensed physician . . 
. for a legitimate medical purpose, for the purpose of correcting a 
physical, mental, or bodily ailment, and acting in good faith in the 
usual course of his professional practice.'' La. Rev. Stat. Ann. 
Sec.  40.961(33).
    \4\ This statute provides that:
    A prescription, in order to be effective in legalizing the 
possession of legend drugs, shall be issued for a legitimate medical 
purpose by one authorized to prescribe the use of such legend drugs. 
An order purporting to be a prescription issued to a drug abuser or 
habitual user of legend drugs, not in the course of professional 
treatment, is not a prescription within the meaning and intent of 
this Section. Any person who knows or should know that he or she is 
filling such a prescription or order to a drug abuser or habitual 
user of legend drugs, as well as the person issuing the 
prescription, may be charged with a violation of this Section.
    La. Rev. Stat. Ann. Sec.  40:1238.2(A).

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[[Page 27999]]

    As the Supreme Court has explained, ``the [CSA's] 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, 
546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 
135, 143 (1975)).
    Under the CSA, it is fundamental that a practitioner must establish 
and maintain a bonafide doctor-patient relationship in order to act 
``in the usual course of . . . professional practice'' and to issue a 
prescription for a ``legitimate medical purpose.'' Laurence T. 
McKinney, 73 FR 43260, 43265 n.22 (2008). The CSA generally looks to 
state law to determine whether a doctor and patient have established a 
bonafide doctor-patient relationship. See Kamir Garces-Mejias, 72 FR 
54931, 54935 (2007); United Prescription Services, Inc., 72 FR 50397, 
50407 (2007); but see 21 U.S.C. Sec.  829(e)(2)(B) (providing federal 
standard for prescribing over the internet). See also United States v. 
Smith, 573 F.3d 639, 647-48 (8th Cir. 2009) (noting that even after 
Gonzales v. Oregon, 546 U.S. 243 (2006), courts of appeals ``have 
applied a general-practice standard when determining whether the 
practitioner acted in the `usual course of professional practice' ''); 
United States v. Merrill, 513 F.3d 1293, 1306 (11th Cir. 2008) (``The 
appropriate focus is not on the subjective intent of the doctor, but 
rather it rests upon whether the physician prescribed medicine `in 
accordance with a standard of medical practice generally recognized and 
accepted in the United States.' '') (quoting Moore, 423 U.S. at 139 
(1975)).
    In support of its contention that Applicant acted outside of the 
usual course of professional practice and lacked a legitimate medical 
purpose when he prescribed phentermine to the two CSs, the Government 
notes that neither CS's BMI met ``medically recognized criteria for 
[being] `overweight' or `obese.' '' Request for Agency Action at 6. 
With respect to CS1, it further contends that the CS stated that ``he/
she was not interested in weight loss, merely weight maintenance.'' Id.
    The Government's contention that the prescriptions violated 21 CFR 
1306.04(a) and were unlawful distributions under the CSA thus appears 
to rest on the theory that this drug can only be lawfully prescribed to 
a person who meets the criteria for being overweight or obese. Notably, 
the Government does not cite to any standards adopted by the Louisiana 
Board of Medical Examiners which govern the prescribing of medications 
in the treatment of weight loss.\5\ Nor does the Government contend 
that the evaluation conducted by Applicant on the two CSs was medically 
inadequate to support the prescribing of Adipex-P. Finally, the 
Government provided no evidence establishing what indications Adipex-P 
is approved for, nor evidence that it is medically inappropriate to 
prescribe this drug to a person who does not meet the criteria for 
being overweight or obese but who seeks to maintain a particular 
weight.\6\
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    \5\ While in his affidavit, the TFO asserted that under various 
guidelines, ``pharmacotherapy should be used on patients with a 
[BMI] over 30 or with a BMI over 27 when certain risk factors for 
disease or concomitant obesity exist,'' this does not establish the 
truth of the converse, i.e, that it is medically unjustified to use 
pharmacotherapy for patients who have lower BMIs or who wish to 
maintain a certain weight. Moreover, in his affidavit, the TFO did 
not set forth any evidence that he possesses medical expertise and 
is thus competent to opine on the medical appropriateness of the 
prescriptions Applicant issued to the CSs.
    \6\ Furthermore, the Government produced no evidence that either 
CS made clear to Applicant that they were seeking the drugs for the 
purpose of abusing them or selling them to others.
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    In Gonzales, the Supreme Court explained that the CSA and its case 
law ``amply support the conclusion that Congress regulates medical 
practice insofar as it bars doctors from using their prescription-
writing powers as a means to engage in illicit drug dealing and 
trafficking as conventionally understood. Beyond this, however, the 
statute manifests no intent to regulate the practice of medicine 
generally.'' 546 U.S. at 270. Thus, even if Adipex-P has not been 
approved by the Food and Drug Administration for marketing for the 
indication of weight maintenance, this alone would not establish a 
violation of the CSA's prescription requirement because a physician can 
lawfully prescribe a drug, including a controlled substance, for an 
off-label use as long as the physician acts in the usual course of 
professional practice and has a legitimate medical purpose for doing 
so. Rather, as set forth in a legion of Agency cases, what establishes 
a violation of this provision (in a proceeding under section 303 or 
304) is proof by substantial evidence that a prescription was issued 
outside of the usual course of professional practice and lacked a 
legitimate medical purpose. 21 CFR 1306.04(a). As to this, the 
Government's evidence is lacking. Accordingly, the allegations related 
to the prescriptions Applicant issued to the CSs are not supported by 
substantial evidence.
    The allegation that Applicant issued numerous prescriptions after 
he allowed his registration to expire is, however, supported by 
substantial evidence. Under Federal law, ``[e]very person who dispenses 
. . . any controlled substance, shall obtain from the Attorney General 
a registration issued in accordance with the rules and regulations 
promulgated by him,'' 21 U.S.C. 822(a)(2), and ``[e]xcept as authorized 
by'' the CSA, it is ``unlawful for any person knowingly or 
intentionally . . . to distribute[] or dispense . . . a controlled 
substance.'' Id. Sec.  841(a)(1); see also 21 CFR 1301.11(a), id. 
1306.03(a)(2). Moreover, it ``unlawful for any person knowingly or 
intentionally . . . to use in the course of the . . . dispensing of a 
controlled substance . . . a registration number which is . . . 
expired[.]'' 21 U.S.C. 843(a)(2). See also 1301.13(a) (``No person 
required to be registered shall engage in any activity for which 
registration is required until the application for registration is 
granted and a Certificate of Registration is issued. . . .'').
    As found above, the Government produced a printout from the 
Louisiana Board of Pharmacy's Prescription Monitoring Program showing 
that from April 1, 2010, the day after Applicant's registration 
expired, through November 5, 2010, he issued nearly 3,500 prescriptions 
for schedule III and IV controlled substances including 
phendimetrazine, diethylproprion, and phentermine. The issuance of each 
prescription is a separate violation of the CSA and DEA regulations. 
See 21 U.S.C. 822(a)(2), 841(a)(1), 843(a)(2); 21 CFR 1301.11(a); id. 
1306.03(a)(2). Accordingly, I hold that the evidence pertaining to 
Applicant's experience in dispensing controlled substances (factor two) 
and compliance with applicable laws related to controlled substances 
(factor four) establishes that the issuance of a registration to him 
``would be inconsistent with the public interest.'' 21 U.S.C. 823(f). 
Accordingly, I will deny the application.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 
CFR 0.100(b), I order that the application of Leo A. Farmer, M.D., for 
a DEA Certificate of Registration as a practitioner, be, and it hereby 
is, denied. This Order is effective June 12, 2013.


[[Page 28000]]


    Dated: May 4, 2013.
Michele M. Leonhart,
Administrator.
[FR Doc. 2013-11268 Filed 5-10-13; 8:45 am]
BILLING CODE 4410-09-P