Notice2024-23504
Salman Akbar, M.D.; Decision and Order
Primary source
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Published
October 10, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 89 Issue 197 (Thursday, October 10, 2024)</title>
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[Federal Register Volume 89, Number 197 (Thursday, October 10, 2024)]
[Notices]
[Pages 82259-82260]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-23504]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Salman Akbar, M.D.; Decision and Order
On January 27, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Salman Akbar, M.D.,
of Richmond, Virginia (Applicant). Request for Final Agency Action
(RFAA), Exhibit (RFAAX) 1, Attachment E, at 1, 4. The OSC proposed the
denial of Applicant's application for a DEA Certificate of Registration
(registration), Control No. W22109452C, alleging that Applicant has
committed acts that would render his registration inconsistent with the
public interest. Id. at 1, 2 (citing 21 U.S.C. 823(g)(1),\1\ 824(a)(4)
\2\).
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\1\ Effective December 2, 2022, the Medical Marijuana and
Cannabidiol Research Expansion Act, Pub. L. 117-215, 136 Stat. 2257
(2022) (Marijuana Research Amendments or MRA), amended the
Controlled Substances Act (CSA) and other statutes. Relevant to this
matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC, as
21 U.S.C. 823(g)(1). Accordingly, this Decision cites to the current
designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA
throughout.
\2\ Prior Agency decisions have addressed whether it is
appropriate to consider a provision of 21 U.S.C. 824(a) when
determining whether to grant a practitioner registration
application. For over forty-five years, Agency decisions have
concluded that it is. Robert Wayne Locklear, M.D., 86 FR 33738,
33744-45 (2021) (collecting cases); see also Dinorah Drug Store,
Inc., 61 FR 15972, 15973-74 (1996).
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The OSC notified Applicant of his right to file with DEA a written
request for hearing, and that if he failed to file such a request, he
would be deemed to have waived his right to a hearing and be in
default. Id. at 2 (citing 21 CFR 1301.43). Here, Applicant filed a
timely answer and request for hearing on February 28, 2023,\3\ but
ultimately withdrew his request for hearing on March 27, 2023. See
RFAAX 1, Attachment F.\4\ On March 27, 2023, Chief Administrative Law
Judge John J. Mulrooney, II, (the Chief ALJ) issued a Termination Order
that terminated the proceedings. 21 CFR 1301.43(c) provides that,
``[i]n the event . . . a person who has requested a hearing fails to
plead . . . or otherwise defend, said party shall be deemed to be in
default . . . .'' By voluntarily withdrawing his hearing request,
Respondent ``fail[ed] to . . . otherwise defend.'' 21 CFR 1301.43(c).
Accordingly, Respondent is ``deemed to be in default.'' Id.; Default
Provisions for Hearing Proceedings Relating to the Revocation,
Suspension, or Denial of a Registration, 87 FR 68036 (Nov. 14,
2022).\5\ See RFAAX 1, Attachment G. ``A default, unless excused, shall
be deemed to constitute a waiver of the registrant's/applicant's right
to a hearing and an admission of the factual allegations of the
[OSC].'' 21 CFR 1301.43(e).
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\3\ Based on the Government's submissions in its RFAA dated July
3, 2023, the Agency finds that service of the OSC on Applicant was
adequate. Specifically, the included Declaration of a DEA Diversion
Investigator indicates that on January 30, 2023, Applicant was
personally served with the OSC. RFAAX 1, at 2.
\4\ Within the document where Applicant withdrew his request for
hearing, Applicant's counsel indicated that Applicant would
``continue with the Corrective Action Plan route that was parallel
to the litigation path, but unrelated to the hearing.'' Id. at 1.
\5\ See also 21 CFR 1301.43(f)(3) (``A party held to be in
default may move to set aside a default final order issued by the
Administrator by filing a motion no later than 30 days from the day
of issuance by the Administrator of a default final order. Any such
motion shall be granted only upon a showing of good cause to excuse
the default.'') Any motion to set aside a default and any response
shall be filed and served by email to the other party and to Office
of the Administrator, Drug Enforcement Administration at
<a href="/cdn-cgi/l/email-protection#f3979692dd9297979cdd9287879c819d968a80b3979692dd949c85"><span class="__cf_email__" data-cfemail="395d5c5817585d5d5617584d4d564b575c404a795d5c58175e564f">[email protected]</span></a>.
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Further, ``[i]n the event that a [registrant/applicant] . . . is
deemed to be in default . . . DEA may then file a request for final
agency action with the Administrator, along with a record to support
its request. In such circumstances, the Administrator may enter a
default final order pursuant to [21 CFR] Sec. 1316.67.'' Id. Sec.
1301.43(f)(1). Here, the Government has requested final agency action
based on Applicant's default pursuant to 21 CFR 1301.43(c), (d),
1301.46. RFAA, at 1; see also 21 CFR 1316.67.
I. Findings of Fact
The Agency finds that, in light of Applicant's default, the factual
allegations in the OSC are admitted. Applicant is deemed to have
admitted that on March 2, 2020, DEA issued Applicant an Immediate
Suspension Order and Order to Show Cause that suspended Applicant's
previous DEA registration, Control No. BA5092856, and immediately
rendered Applicant without authority to issue prescriptions for
controlled substances. RFAAX 1, Attachment E, at 1-2; see also RFAAX 1,
Attachment B. Further, on October 20, 2021, by Order of the then-Acting
Administrator, Applicant's DEA registration, Control No. BA5092856, was
revoked. RFAAX 1, Attachment E, at 2; see also RFAAX 1, Attachment C.
Nonetheless, Applicant is deemed to have admitted, and the Agency
finds, that between on or about January 15, 2021, and on or about
January 6, 2022, Applicant issued at least 17 prescriptions for
controlled substances, including four prescriptions for oxycodone (a
Schedule II controlled substance), two prescriptions for hydrocodone (a
Schedule II controlled substance), five prescriptions for lorazepam (a
Schedule IV controlled substance), two prescriptions for zolpidem (a
Schedule IV controlled substance), one prescription for clonazepam (a
Schedule IV controlled substance), two prescriptions for pregabalin (a
Schedule V controlled substance), and one prescription for diazepam (a
Schedule IV controlled substance). RFAAX 1, Attachment E, at 2; see
also RFAAX 1, Attachment D. Applicant is deemed to have admitted, and
the Agency finds, that each of these 17 prescriptions was issued
without a DEA registration and outside the usual course of professional
practice. Id.
II. Discussion
A. The Five Public Interest Factors
Pursuant to section 303(g)(1) of the CSA, ``[t]he 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.'' 21 U.S.C. 823(g)(1). Section 303(g)(1) further 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.'' Id. In making the
public interest determination, the CSA requires consideration of the
following factors:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(C) The applicant's conviction record under Federal or State
laws relating to the
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manufacture, distribution, or dispensing of controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(g)(1).
The Agency considers these public interest factors in the
disjunctive. Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each
factor is weighed on a case-by-case basis. Morall v. Drug Enf't Admin.,
412 F.3d 165, 173-74 (D.C. Cir. 2005). Any one factor, or combination
of factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508
(1993).
While the Agency has considered all of the public interest factors
in 21 U.S.C. 823(g)(1),\6\ the Government's evidence in support of its
prima facie case for denial of Applicant's application for registration
is confined to Factors B and D. See RFAAX 1, Attachment E, at 1.
Moreover, the Government has the burden of proof in this proceeding. 21
CFR 1301.44. Here, the Agency finds that the Government's evidence
satisfies its prima facie burden of showing that Applicant's
registration would be ``inconsistent with the public interest.'' 21
U.S.C. 824(a)(4).
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\6\ As to Factor A, the record contains no evidence of a
recommendation from any State licensing board or professional
disciplinary authority. 21 U.S.C. 823(g)(1)(A). Nonetheless, an
absence of such evidence ``does not weigh for or against a
determination as to whether continuation of [or granting of a] DEA
certification is consistent with the public interest.'' Roni
Dreszer, M.D., 76 FR 19434, 19444 (2011). As to Factor C, there is
no evidence in the record that Applicant has been convicted of an
offense under either Federal or State law ``relating to the
manufacture, distribution, or dispensing of controlled substances.''
21 U.S.C. 823(g)(1)(C). However, as Agency cases have noted, there
are a number of reasons why a person who has engaged in criminal
misconduct may never have been convicted of an offense under this
factor. Dewey C. MacKay, M.D., 75 FR 49956, 49973 (2010). Agency
cases have therefore found that ``the absence of such a conviction
is of considerably less consequence in the public interest inquiry''
and is therefore not dispositive. Id. Finally, as to Factor E, the
Government's evidence fits squarely within the parameters of Factors
B and D and does not raise ``other conduct which may threaten the
public health and safety.'' 21 U.S.C. 823(g)(1)(E). Accordingly,
Factor E does not weigh for or against Applicant.
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B. Factors B and D
Evidence is considered under Public Interest Factors B and D when
it reflects compliance (or non-compliance) with laws related to
controlled substances and experience dispensing controlled substances.
See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D.,
87 FR 21156, 21162 (2022). In the current matter, the Government has
alleged that Applicant violated both Federal and State law regulating
controlled substances. RFAAX 1, Attachment E, at 2.\7\ Specifically,
Federal law states that ``[a] prescription for a controlled substance
may be issued only by an individual practitioner who is: (1)
[a]uthorized to prescribe controlled substances by the jurisdiction in
which he is licensed to practice his profession and (2) [e]ither
registered or exempted from registration pursuant to Sec. Sec.
1301.22(c) and 1301.23 . . . .'' 21 CFR 1306.03(a)(1-2). As for State
law, Virginia statute requires that ``[e]very person who manufactures,
distributes or dispenses any substance that is controlled in
[s]chedules I through V . . . except . . . those persons who are
licensed practitioners of medicine . . . shall obtain annually a
controlled substances registration certificate issued by the [Board of
Pharmacy]. This registration shall be in addition to other licensing or
permitting requirements enumerated in [Virginia's Drug Control Act] or
otherwise required by law.'' Va. Code. Ann. section 54.1-3422(A).
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\7\ The Agency need not adjudicate the criminal violations
alleged in the instant OSC. Ruan v. United States, 142 S. Ct. 2370
(2022) (decided in the context of criminal proceedings).
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Here, Applicant has admitted that he repeatedly issued
prescriptions for controlled substances while his DEA registration was
suspended as well as after his DEA registration was revoked. As such,
the Agency finds that Applicant violated 21 CFR 1306.03(a)(1-2) and
Virginia Code section 54.1-3422(A).
Accordingly, the Agency finds that Factors B and D weigh in favor
of denial of Applicant's application and thus finds Applicant's
continued registration to be inconsistent with the public interest in
balancing the factors of 21 U.S.C. 823(g)(1). The Agency further finds
that Applicant failed to provide any evidence to rebut the Government's
prima facie case.
III. Sanction
Where, as here, the Government has established grounds to deny
Applicant's application, the burden shifts to the registrant to show
why he can be entrusted with the responsibility carried by a
registration. Garret Howard Smith, M.D., 83 FR 18882, 18910 (2018). To
establish that he can be entrusted with registration, a registrant must
both accept responsibility and demonstrate that he has undertaken
corrective measures. Holiday CVS, L.L.C., dba CVS Pharmacy Nos 219 and
5195, 77 FR 62316, 62339 (2012) (internal quotations omitted); see also
Michele L. Martinho, M.D., 86 FR 24012, 24019 (2021); George D. Gowder,
III, M.D., 89 FR 76152, 76154 (2024). Trust is necessarily a fact-
dependent determination based on individual circumstances; therefore,
the Agency looks at factors such as the acceptance of responsibility,
the credibility of that acceptance as it relates to the probability of
repeat violations or behavior, the nature of the misconduct that forms
the basis for sanction, and the Agency's interest in deterring similar
acts. See, e.g., Robert Wayne Locklear, M.D., 86 FR at 33746.
Here, although Applicant initially requested a hearing, he
ultimately withdrew his hearing request and did not otherwise avail
himself of the opportunity to refute the Government's case. As such,
Applicant has made no representations as to his future compliance with
the CSA nor demonstrated that he can be entrusted with registration.
Moreover, the evidence presented by the Government shows that Applicant
violated the CSA, further indicating that Applicant cannot be
entrusted. Accordingly, the Agency will order the denial of Applicant's
application.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(g)(1) and 21 U.S.C. 824(a), I hereby deny the pending
application for a Certificate of Registration, Control No. W22109452C,
submitted by Salman Akbar, M.D., as well as any other pending
application of Salman Akbar, M.D., for additional registration in
Virginia. This Order is effective November 12, 2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 4, 2024, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-23504 Filed 10-9-24; 8:45 am]
BILLING CODE 4410-09-P
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