Registrant Actions - 2010
[Federal Register: October 26, 2010 (Volume 75, Number 206)]
[Notices]
[Page 65660-65663]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc10-109]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Steven B. Brown, M.D.; Revocation of Registration
On May 13, 2010, I, the Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and Immediate
Suspension of Registration ("Order") to Steven B. Brown, M.D.
("Registrant"), of Wilton Manors and Pompano Beach, Florida. The
Order proposed the revocation of Registrant's DEA Certificates of
Registration, BB2972140 and FB1490349, as well as the denial of any
pending applications for the renewal or modification of both
registrations, on the ground that his "continued registrations are
inconsistent with the public interest, as that term is defined in 21
U.S.C. 823(f)." Order, at 1.
The Order alleged that Registrant "issued illegal prescriptions
for oxycodone, a Schedule II controlled
[[Page 65661]]
substance, for no legitimate medical purpose and outside the course of
[his] professional practice." Id. at 1-2 (citing 21 U.S.C. 841(a) and
21 CFR 1306.04(a)). More specifically, the Order alleged that
Registrant "prescribed oxycodone 30 mg. tablets in amounts as high as
180 dosage units to patients" and that he "received half the dosage
units back from the patients after the illegal prescription was filled
and dispensed." Id. at 2. The Order also alleged that on March 27,
2010, "[a]s a result of [Registrant's] illegal prescribing and [his]
illegal possession of controlled substances," Registrant "was
arrested by the Broward County Sheriff's Office." Id. Moreover, the
Order alleged that on April 28, 2010, Registrant "illegally possessed
amphetamine, a Schedule II controlled substance" and was "arrested by
the Broward County Sheriff's Office during an Administrative Inspection
by the Florida Department of Health" at one of his registered
locations. Id. Finally, the Order alleged that "[a]s a result of
actions by the State of Florida Department of Health," Registrant is
"currently without authority to handle controlled substances in the
State of Florida," the State in which he is registered with DEA. Id.
Based on the above, I concluded "that [Registrant's] continued
registrations, while these proceedings are pending, constitute an
imminent danger to the public health and safety." Id. (citing 21
U.S.C. 824(d) and 21 CFR 1301.36(e)). I, therefore, ordered the
immediate suspension of both of Registrant's registrations. Id.
On May 17, 2010, the Order, which also notified Registrant of his
right to request a hearing on the allegations or to submit a written
statement in lieu of a hearing, the procedure for doing either, and the
consequence for failing to do either, was served on him. See Order, at
3 (citing 21 CFR 1301.43); Gov't Not. of Svc. of Order. Since the date
of service of the Order, 30 days have passed and neither Respondent,
nor anyone purporting to represent him, has requested a hearing or
submitted a written statement in lieu of a hearing. I, therefore, hold
that Respondent has waived his right to a hearing or to submit a
written statement 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 of fact.
Findings
Registrant is a physician licensed by the State of Florida. He is
the holder of two DEA Certificates of Registration: (1) BB2972140 (as
well as XB2972140), at the registered address of 1749 N.E. 26th Street,
Suite A, Wilton Manors, Florida; and (2) FB1490349, at the registered
address of 605 East Atlantic Blvd, Pompano Beach, Florida. Both
registrations do not expire until July 31, 2012.
Registrant practiced pain management at his Pompano Beach
registered location. Order of Emergency Suspension of License, at 2, In
re: Steven Barry Brown, M.D., (Fla. Dep't of Health, Nos. 2010-06419,
2010-07923) (hereinafter, State Susp. Order). He is also registered
under Florida law as a dispensing practitioner; this authorizes him to
order and dispense controlled substances in the State.
In March 2010, DEA and the Broward County Sheriff's Office
("BSO") received information from a confidential source ("CS") that
Registrant was issuing prescriptions for oxycodone \1\ 30 mg. to the CS
and providing her with money to fill the prescriptions; in exchange,
the CS gave Registrant half of the pills she obtained. Declaration of
Diversion Investigator (DI), at 1-2. According to the CS, Registrant
had been treating her for chronic pain for the last four years.
However, after two years, Registrant proposed that he would write her
prescriptions for 160 tablets of oxycodone 30 mg. and give her the
money to pay for them "if the CS would give half the pills back to"
him. Id.; see also Stat. Susp. Order, at 2. The CS agreed to the
arrangement. Id.
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\1\ Oxycodone is a schedule II controlled substance. 21 CFR
1308.12(b)(1)(xiii).
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Each month for two years, Registrant wrote the CS prescriptions for
up to 180 tablets of oxycodone 30 mg. and gave her the money to fill
them; the CS would then provide Registrant with half of the pills she
obtained. Declaration, at 2. Registrant told the CS to fill the
prescriptions at local pharmacies and not at his clinic. Id. The CS
also related to the Investigator that Registrant was abusing oxycodone
and Dilaudid. Id. at 2.
At about 6:16 p.m. on March 27, 2010, the CS, under the direction
of a BSO officer and a DI, made a consensually recorded telephone call
to Registrant to arrange a delivery of oxycodone to him. During the
call, Registrant twice asked the CS if she had split the oxycodone up;
the CS answered affirmatively. The CS and Registrant then agreed to
meet in the parking lot of a local fast food restaurant.
During the delivery, which was observed by several law enforcement
officers, the CS wore a recording device. Id. Upon meeting, Registrant
asked the CS if she "want[ed] one of these hits?" and stated: "Oh
their good." The CS replied "Yeah" and Registrant then said: "You
know what I'm talking about right? It's Percocet liquid." The CS
replied that she knew "that's the Oxyfast" but added that she did not
want any because it would upset her stomach. Acknowledging that the
drug would do so, Registrant stated: "You know what I do? To make it
taste better I put Wyler's Raspberry in it." Registrant then added:
"It's so good." The CS, however, again said that she did not want any
of the drug. The CS then gave the oxycodone to Registrant, who gave her
eighty dollars. The CS left, and shortly thereafter, Registrant was
arrested and charged with trafficking in oxycodone.
On May 5, 2010, the State Surgeon General, Florida Department of
Health (DOH), issued an Order of Emergency Suspension of License which
immediately suspended Registrant's physician's license. State
Suspension Order, at 1, 12. The Order alleged that Registrant
"violated Section 458.331(1)(q)" of the Florida Statutes "by
prescribing medications to [three individuals] with no medical records
justifying why the prescriptions were being written," Id. at 10, as
well as "by prescribing * * * a legend drug, including any controlled
substance, other than in the course of the physician's professional
practice." Id. at 11.
The State Suspension Order further alleged "that [Registrant] has
shown a disregard for the safety of the public with his practice of
prescribing medications to patients with no medical records to justify
why the prescriptions were being written" and that his "practice was
especially egregious in that he was using his relationship as a
physician with a patient to divert medication for his own use." Id.
Accordingly, the State Suspension Order concluded that Registrant's
"actions clearly constitute prescribing outside the practice of
medicine and present such an immediate, serious danger to the public
health, safety or welfare that nothing short of the immediate
suspension of his license to practice medicine will protect the public
from this danger." Id.
Discussion
Section 304(a) of the Controlled Substances Act ("CSA") provides
that a "registration pursuant to section 823 of this title to * * *
dispense a controlled substance * * * may be suspended or revoked by
the Attorney General upon a finding that the registrant * * * has had
his State license suspended, revoked, or denied by competent State
authority and is no longer authorized by
[[Page 65662]]
State law to engage in the * * * dispensing of controlled substances,"
21 U.S.C. 824(a)(3), or "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." Id. Sec.
824(a)(4). With respect to the latter ground for revocation, the CSA
directs 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.
21 U.S.C. 823(f).
The public interest "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 revoke an existing
registration or 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); see also Morall v DEA, 412 F.3d 165,
173-74 (D.C. Cir. 2005).
As explained below, the investigative record clearly shows that
Registrant's experience in dispensing controlled substances and
compliance with applicable laws is characterized by his unlawful use of
his prescribing authority to obtain controlled substances for his
personal use. Moreover, the record also shows that by virtue of the
State Suspension Order, Registrant no longer has authority under
Florida law to dispense controlled substances and thus, he no longer
meets an essential requirement for holding a DEA registration. I will
therefore order that Registrant's Certificates of Registration be
revoked.
The Public Interest Grounds
Factors Two, Four, and Five: Registrant's Experience in Dispensing
Controlled Substances, Record of Compliance With Applicable Controlled
Substance Laws, and Such Other Conduct Which May Threaten Public Health
and Safety
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 relating
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.")
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, 546
U.S. 243, 274 (2006) (citing United States v Moore, 423 U.S. 122, 135,
143 (1975)).
As found above, in order to obtain drugs for his own use,
Registrant entered into an agreement with the CS to provide her with
monthly prescriptions for 160 to 180 tablets of oxycodone 30 mg.
Registrant paid for the prescriptions in exchange for the CS's
providing him with half of the pills. Registrant wrote the
prescriptions on a monthly basis for a two-year period.
While during this period, Registrant may have been treating the CS
for legitimate chronic pain (although with another drug), it is clear
that Registrant's primary purpose in writing these prescriptions was to
obtain drugs that he then abused. Each of the prescriptions Registrant
wrote thus violated 21 CFR 1306.04(a) and constituted an unlawful
distribution of a controlled substance. See 21 U.S.C. 841(a)(1)
("Except as authorized by this subchapter, it shall be unlawful for
any person knowingly or intentionally * * * to manufacture, distribute,
or dispense, or possess with intent to manufacture, distribute, or
dispense, a controlled substance."). See also Michael F. Myers, 72 FR
36464, 36486 (2007) (finding Respondent "engaged in the criminal
distribution of controlled substances in violation of 21 U.S.C. 841"
where Respondent "issued [a] person prescriptions for hydrocodone on a
monthly basis * * * [and the] person admitted * * * that he took very
few hydrocodone tablets and regularly provided Respondent with 60 of
them").
Under the CSA, it is also "unlawful for any person knowingly or
intentionally * * * to acquire or obtain possession of a controlled
substance by misrepresentation, fraud, forgery, deception, or
subterfuge." 21 U.S.C. 843(a)(3). Even assuming that the CS required
her share of the oxycodone to treat a legitimate medical condition, by
writing prescriptions in excess of the CS's legitimate medical needs
and for the purpose of obtaining the drugs for his own use, Registrant
obtained possession of controlled substances by "deception[] or
subterfuge" and violated Federal law.
Moreover, Florida prohibits the prescribing of "inappropriate
quantities" of legend drugs, including controlled substances. Fla.
Stat. 458.331(1)(q). Again, even assuming that the CS had a legitimate
medical need for her share of the oxycodone, Registrant violated
Florida law because the prescriptions he issued to her clearly exceeded
the quantity necessary to treat her condition and were issued in those
quantities so that he could obtain drugs for his own use.
Additionally, DEA has long held that a practitioner's self-abuse of
controlled substances constitutes "conduct which may threaten public
health and safety." 21 U.S.C. 823(f)(5). See Tony T. Bui, 75 FR 49979,
49990 (2010); Kenneth Wayne Green, Jr., 59 FR 51453 (1994); David E.
Trawick, 53 FR 5326 (1988). In addition to the evidence showing that
Registrant issued prescriptions to the CS to obtain controlled
substances for his own use, the evidence also shows that during the
March 27, 2010 meeting with the CS, he offered her a hit of liquid
oxycodone, stating "Oh their good," and then explained how he made it
more palatable to ingest. Thus, it is clear that Registrant is a drug
abuser and a threat to public health and safety.\2\
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\2\ I conclude that it is not necessary to make findings under
factor one because Registrant's loss of his State authority will be
considered separately in this Decision.
As for factor three, while there is evidence that Registrant
was arrested on drug charges, there is no evidence as to the
disposition of the charges. Nor is there any evidence establishing
that Registrant has otherwise been convicted of any offenses within
the purview of factor three. However, DEA has repeatedly held that
the absence of any convictions under factor three is not dispositive
of the public interest inquiry. See, e.g., Edmund Chein, 72 FR 6580,
6593 n.22 (2007).
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I, therefore, conclude that the evidence pertinent to Registrant's
experience in dispensing controlled substances (factor two), his record
of compliance with Federal and State laws related to controlled
substances (factor
[[Page 65663]]
four), and such other conduct which may threaten public health and
safety (factor five), establishes that he has committed acts which
render his continued registration "inconsistent with the public
interest." 21 U.S.C. 824(a)(4). This finding provides reason alone to
revoke Registrant's registrations and to deny any pending applications
to renew or modify his registrations.
The Loss of State Authority Ground
Under the CSA, a practitioner must possess authority to dispense
controlled substances under the laws of the State in which he engages
in his professional practice in order to obtain and maintain a DEA
registration. See 21 U.S.C. 802(21) (defining the term "practitioner"
as a person "licensed, registered, or otherwise permitted, by the
United States or the jurisdiction in which he practices * * * to
distribute, dispense * * * [or] administer * * * a controlled
substance"), id. Sec. 823(f) ("The Attorney General shall register
practitioners * * * to dispense * * * controlled substances * * * if
the applicant is authorized to dispense * * * controlled substances
under the laws of the State in which he practices."). As these
provisions make plain, possessing authority under State law to handle
controlled substances is an essential condition for holding a DEA
registration. See John B. Freitas, 74 FR 17524, 17525 (2009); Dominick
A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920
(1988).
DEA, has therefore, held repeatedly that the CSA requires the
revocation of a registration issued to a practitioner whose State
authority has been suspended or revoked. David W. Wang, 72 FR 54297,
54298 (2007); Sheran Arden Yeates, 71 FR 39130, 39131 (2006); Dominick
A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920
(1988). See also id. Sec. 824(a)(3) (a "registration pursuant to
section 823 of this title to * * * dispense a controlled substance * *
* may be suspended or revoked by the Attorney General upon a finding
that the registrant * * * has had his State license suspended, revoked,
or denied by competent State authority and is no longer authorized by
State law to engage in the * * * dispensing of controlled
substances"). DEA has further held that revocation is warranted even
where a practitioner's State authority has been summarily suspended and
the State has yet to provide the practitioner with a hearing to
challenge the State's action. See Robert Wayne Mosier, 75 FR 49950
(2010) ("revocation is warranted * * * even in those instances where a
practitioner's State license has only been suspended, and there is the
possibility of reinstatement"); accord Bourne Pharmacy, 72 FR 18273,
18274 (2007).
As found above, on May 5, 2010, the Florida Surgeon General
immediately suspended Registrant's State medical license. Registrant is
therefore without authority to dispense controlled substances in the
State where he holds his DEA registrations. Registrant's loss of his
State authority thus provides an additional basis for revoking his
registrations. Accordingly, his registrations will be revoked and any
pending application will be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as 28 CFR 0.100(b) and 0.104, I order that DEA
Certificates of Registration BB2972140, XB2972140, and FB1490349,
issued to Stephen B. Brown, M.D., be, and they hereby are, revoked. I
further order that any pending application of Stephen B. Brown, M.D.,
to renew or modify such registrations, be, and it hereby is, denied.
This order is effective immediately.\3\
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\3\ For the same reason that I ordered the immediate suspension
of Registrant's DEA registrations, I conclude that the public
interest requires that this Order shall be effective immediately.
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Dated: October 15, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-27031 Filed 10-25-10; 8:45 am]
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