[Federal Register Volume 90, Number 113 (Friday, June 13, 2025)]
[Notices]
[Pages 25083-25086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10742]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
James F. Brown, D.P.M.; Default Decision and Order
I. Introduction
On June 26, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to James F. Brown,
D.P.M., of Los Angeles, California (Registrant). Request for Final
Agency Action (RFAA), Exhibit (RFAAX) 2, at 1, 5. The OSC proposed the
revocation of Registrant's DEA Certificate of Registration No.
BB7959731, alleging that Registrant's registration should be revoked
because Registrant materially falsified his application for DEA
registration and because Registrant has no state authority to handle
controlled substances. Id. at 1 (citing 21 U.S.C. 824(a)(1), (3)).\1\
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\1\ In its RFAA, the Government repeatedly uses variations of
the term denial (applicable to a decision regarding a DEA
registration application) rather than revocation (applicable to a
decision regarding a current DEA registration). This appears to be
an error, as the conclusion of the RFAA ultimately requests
revocation of Registrant's current DEA registration, not denial of a
DEA registration application.
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The OSC alleged that Registrant materially falsified his
application for DEA registration by failing to disclose that his
California medical license was previously suspended. Id. at 2-3. The
OSC also alleged that, due to the terms and conditions of Registrant's
current probation regarding his California medical license, Registrant
does not have authority to handle controlled substances in California,
the state in which he is registered with DEA. Id. at 3.
The OSC notified Registrant of his right to file with DEA a written
request for a hearing and an answer, 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 3 (citing 21 CFR 1301.43). Here, Registrant did
not request a hearing. RFAA, at 3.\2\
[[Page 25084]]
``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); see also RFAAX
2, at 3 (providing notice to Registrant).
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\2\ Based on the Government's submissions in its RFAA dated
October 24, 2024, the Agency finds that service of the OSC on
Registrant was adequate. According to the Declaration from a DEA
Diversion Investigator (DI), on June 27, 2024, the DI mailed the OSC
via First Class mail to Registrant's registered address, mailing
address, and ``each of the previously listed addresses in the DEA
databases associated with [Registrant].'' RFAAX 3, at 2. Further, on
July 1, 2024, the DI emailed copies of the OSC to Registrant and
Registrant's attorney. Id. On July 31, 2024, the DI traveled to
Registrant's registered address to personally serve him with a copy
of the OSC, but was advised by clinic staff on the premises that
Registrant had not been at that location for two years. Id. On
August 5, 2024, the DI attempted to personally serve Registrant at
an address associated with him in Long Beach, California, but the
current tenant at the address advised the DI that she had been
living at the address since 2023 and had no knowledge of Registrant
or his whereabouts. Id. at 2-3. Here, the Agency finds that
Registrant was successfully served the OSC by email and that the
DI's efforts to serve Registrant by other means were ```reasonably
calculated, under all the circumstances, to apprise [Registrant] of
the pendency of the action.''' Jones v. Flowers, 547 U.S. 220, 226
(2006) (quoting Mullane v. Central Hanover Bank & Trust Co., 339
U.S. 306, 314 (1950)); see also Mohammed S. Aljanaby, M.D., 82 FR
34552, 34552 (2017) (finding that service by email satisfies due
process where the email is not returned as undeliverable and other
methods have been unsuccessful).
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Further, ``[i]n the event that a registrant . . . 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] 1316.67.'' Id. Sec. 1301.43(f)(1). Here, the
Government has requested final agency action based on Registrant's
default pursuant to 21 CFR 1301.43(c), (f), 1301.46. RFAA, at 4; see
also 21 CFR 1316.67.
II. Lack of State Authority
A. Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC are deemed admitted. Accordingly,
Registrant admits that on March 15, 2024, the Podiatric Medical Board
of California (PMB) revoked Registrant's California medical license,
stayed the revocation, and placed Registrant on probation for five
years. RFAAX 2, at 3. Registrant also admits that the terms and
conditions of his probation prohibit him from handling controlled
substances. Id. According to California online records, of which the
Agency takes official notice,\3\ Registrant's California medical
license is current, but also on probation with limits on his practice.
California DCA License Search, https://search.dca.ca.gov (last visited
date of signature of this Order). Specifically, on the ``Licensing
Details'' page for Registrant's California medical license number 4434,
under ``Administrative Disciplinary Actions,'' the online record
states: ``Five years' probation with various terms and conditions.
Restrictions: shall not order, prescribe, dispense, administer or
possess any controlled substances as defined in the California Uniform
Controlled Substances Act; shall not engage in the practice of
podiatric medicine until notified by the Board or its designee that
[Registrant] is mentally fit to practice podiatric medicine safely; and
prohibited from engaging in the solo practice of medicine . . . .'' Id.
(capitalization edited). Accordingly, the Agency finds that Registrant
is not licensed to handle controlled substances in California, the
state in which he is registered with DEA.\4\
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\3\ Under the Administrative Procedure Act, an agency ``may take
official notice of facts at any stage in a proceeding--even in the
final decision.'' United States Department of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979).
\4\ Pursuant to 5 U.S.C. 556(e), ``[w]hen an agency decision
rests on official notice of a material fact not appearing in the
evidence in the record, a party is entitled, on timely request, to
an opportunity to show the contrary.'' The material fact here is
that Registrant, as of the date of this decision, is not authorized
to handle controlled substances in California. Registrant may
dispute the Agency's finding by filing a properly supported motion
for reconsideration of findings of fact within fifteen calendar days
of the date of this Order. Any such motion and response shall be
filed and served by email to the other party and to DEA Office of
the Administrator, Drug Enforcement Administration at
[email protected].
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B. Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under 21 U.S.C. 823 ``upon a
finding that the registrant . . . has had his State license or
registration suspended . . . [or] revoked . . . by competent State
authority and is no longer authorized by State law to engage in the . .
. dispensing of controlled substances.'' With respect to a
practitioner, DEA has also long held that the possession of authority
to dispense controlled substances under the laws of the state in which
a practitioner engages in professional practice is a fundamental
condition for obtaining and maintaining a practitioner's registration.
Gonzales v. Oregon, 546 U.S. 243, 270 (2006) (``The Attorney General
can register a physician to dispense controlled substances `if the
applicant is authorized to dispense . . . controlled substances under
the laws of the State in which he practices.' . . . The very definition
of a `practitioner' eligible to prescribe includes physicians
`licensed, registered, or otherwise permitted, by the United States or
the jurisdiction in which he practices' to dispense controlled
substances. Sec. 802(21).''). The Agency has applied these principles
consistently. See, e.g., James L. Hooper, M.D., 76 FR 71371, 71372
(2011), pet. for rev. denied, 481 F. App'x 826 (4th Cir. 2012);
Frederick Marsh Blanton, M.D., 43 FR 27616, 27617 (1978).\5\
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\5\ This rule derives from the text of two provisions of the
CSA. First, Congress defined the term ``practitioner'' to mean ``a
physician . . . or other person licensed, registered, or otherwise
permitted, by . . . the jurisdiction in which he practices . . ., to
distribute, dispense, . . . [or] administer . . . a controlled
substance in the course of professional practice.'' 21 U.S.C.
802(21). Second, in setting the requirements for obtaining a
practitioner's registration, Congress directed that ``[t]he Attorney
General shall register practitioners . . . 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). Because
Congress has clearly mandated that a practitioner possess state
authority in order to be deemed a practitioner under the Controlled
Substances Act (CSA), DEA has held repeatedly that revocation of a
practitioner's registration is the appropriate sanction whenever he
is no longer authorized to dispense controlled substances under the
laws of the state in which he practices. See, e.g., James L. Hooper,
M.D., 76 FR 71371-72; Sheran Arden Yeats, M.D., 71 FR 39130, 39131
(2006); Dominick A. Ricci, M.D., 58 FR 51104, 51105 (1993); Bobby
Watts, M.D., 53 FR 11919, 11920 (1988); Frederick Marsh Blanton,
M.D., 43 FR 27617.
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According to California statute, ``dispense'' means ``to deliver a
controlled substance to an ultimate user or research subject by or
pursuant to the lawful order of a practitioner, including the
prescribing, furnishing, packaging, labeling, or compounding necessary
to prepare the substance for that delivery.'' Cal. Health & Safety Code
section 11010 (West 2024). Further, a ``practitioner'' means a person
``licensed, registered, or otherwise permitted, to distribute,
dispense, conduct research with respect to, or administer, a controlled
substance in the course of professional practice or research in [the]
state.'' Id. at section 11026(c).
Here, the undisputed evidence in the record is that Registrant
currently lacks authority to handle controlled substances in California
because his California medical license, while current, has been limited
to prohibit the handling of controlled substances, among other
limitations. As discussed above, an individual must be a practitioner
licensed to handle controlled substances in order to handle controlled
substances in California.
[[Page 25085]]
Thus, because Registrant is not currently authorized to handle
controlled substances in California, Registrant is not eligible to
maintain a DEA registration. Accordingly, the Agency will order that
Registrant's DEA registration be revoked.
III. Material Falsification
A. Findings of Fact
Registrant admits that on May 8, 2023, the PMB issued an Ex Parte
Interim Suspension Order that prohibited him from practicing medicine
in California based on allegations relating to driving under the
influence, practicing medicine while impaired, being convicted of a
drug related offense, excessively using drugs or alcohol, and
unprofessional conduct. RFAAX 2, at 2. Registrant further admits that
on June 5, 2023, the PMB granted an Immediate Suspension Order after a
hearing where Registrant was represented by counsel. Id.
Registrant admits that on June 20, 2023, he submitted an
application for renewal of his DEA registration. Id.; see also RFAAX 8,
at 1. Registrant admits that a DEA application for registration
includes liability questions that must be answered either affirmatively
or negatively. RFAAX 2, at 2. Registrant admits that Liability Question
3 asks: ``Has the applicant ever surrendered (for cause) or had a state
professional license or controlled substance registration revoked,
suspended, denied, restricted, or placed on probation, or is any such
action pending?'' Id.; see also RFAAX 8, at 1. Registrant admits that
on his application, in response to Liability Question 3, he answered
``N'', thus concealing that his California medical license had been
suspended (as noted above). RFAAX 2, at 3; see also RFAAX 8, at 1.
B. Discussion
The Administrator is authorized to revoke a registration if the
registrant has materially falsified an application for registration. 21
U.S.C. 824(a)(1). Agency decisions have repeatedly held that false
responses to the liability questions on an application for registration
are material. Kevin J. Dobi, APRN, 87 FR 38184, 38184 (2022)
(collecting cases).
In Frank Joseph Sirlacci, M.D., the Agency found that ``the
falsification of any of the liability questions is `material' under 21
U.S.C. 824(a)(1) . . . [because] each of the liability questions is
connected to at least one of [the] [21 U.S.C. 823(g)(1)] factors that,
according to the CSA, [the Agency] `shall' consider as [it] analyze[s]
whether issuing a registration `would be inconsistent with the public
interest.' [21 U.S.C. 823(g)(1)].'' Frank Joseph Stirlacci, M.D., 85 FR
45229, 45238 (2020) (footnote omitted). The Decision noted that ``[the
Agency is] unable to discharge the responsibilities of the CSA every
time [it is] given false information in response to a liability
question. Thus, each falsification of a liability question has a
natural tendency to influence, or is capable of influencing [the
Agency's] decision and is therefore material.'' Id.\6\
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\6\ See also JM Pharmacy Group, Inc., d/b/a Farmacia Nueva and
Best Pharma Corp., 80 FR 28667, 28681 (2015) (``[T]he allegedly
false statement must be analyzed in the context of the application
requirements sought by DEA and provided by the applicant. The
falsification must relate to a ground that could affect the
decision, not merely a basis upon which an investigation could be
initiated.''); Mark William Andrew Holder, M.D., 80 FR 71618, 71624
n.19 (2015) (quoting Kungys v. United States, 485 U.S. 759, 771
(1988) (```It has never been the test of materiality that the
misrepresentation or concealment would more likely than not have
produced an erroneous decision, or even that it would more likely
than not have triggered an investigation . . . . Instead, the test
is whether the misrepresentation or concealment was predictably
capable of affecting, i.e., had a natural tendency to affect, the
official decision . . . . [T]he ultimate finding of materiality
turns on an interpretation of substantive law.'''); Scott C.
Bickman, M.D., 76 FR 17694, 17701 (2011) (``the relevant decision
for assessing whether a false statement is material is not the
decision to conduct an investigation, but rather the decision as to
whether an applicant is entitled to be registered.'').
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The Government must prove an allegation of material falsification
``by evidence that is clear, unequivocal, and convincing.'' Richard J.
Settles, D.O., 81 FR 64940, 64946 (2016) (quoting Kungys v. United
States, 485 U.S. at 772). The Government need not show that an
applicant actually knew that his response to a liability question was
false. Rather, it is sufficient that the Government shows that an
applicant should have known that his response to a liability question
was false. Narciso A. Reyes, M.D., 83 FR 61678, 61680 (2018) (citing
Samuel S. Jackson, D.D.S., 72 FR 23848, 23852 (2007)). When the
Government has made such a showing, i.e., that an applicant should have
known that his response to a liability question was false, an
applicant's claim that he actually misunderstood a liability question,
or otherwise inadvertently provided a false answer to a liability
question, is not a defense. Id. (citing Alvin Darby, M.D., 75 FR 26993,
26999 (2010)). Indeed, the applicant bears the responsibility to
carefully read the liability questions and to answer them honestly;
``[a]llegedly misunderstanding or misinterpreting liability questions
does not relieve the applicant of this responsibility.'' Zelideh I.
Cordova-Velazco, M.D., 83 FR 62902, 62906 (2018) (internal citations
omitted).
As detailed above, Registrant admits that on June 5, 2023, the PMB
suspended Registrant's California medical license following a hearing.
See supra III.A. Registrant also admits that on his June 20, 2023
application for renewal of his DEA registration, he answered ``N'' to
Liability Question 3, which asked whether he had ever `` . . . had a
state professional license or controlled substance registration
revoked, suspended, denied, restricted, or placed on probation . . . ''
Id. Accordingly, the Agency finds clear, unequivocal, and convincing
evidence that Registrant falsely answered ``N'' to Liability Question 3
when he knew or should have known that the correct answer was ``Y.''
Further, as discussed above, a false answer to liability question 3
is material because the question is directly connected to the analysis
the Agency must conduct under 21 U.S.C. 823 and is thus capable of
influencing the Agency's decision. Accordingly, the Agency finds clear,
unequivocal, and convincing evidence that Registrant materially
falsified his renewal application with regard to Liability Question 3.
Having read and analyzed the record, the Agency finds clear,
unequivocal, convincing, and unrebutted evidence that Registrant's June
20, 2023 application for renewal of his DEA registration contains a
material falsification because Registrant gave a false answer to a
liability question. Accordingly, the Agency finds that the Government
established a prima facie case, that Registrant did not rebut that
prima facie case, and that there is substantial record evidence
supporting the revocation of Registrant's registration. 21 U.S.C.
824(a)(1).
C. Sanction
Here, the Government has met its prima facie burden of showing that
Registrant materially falsified his application for renewal of his DEA
registration. Accordingly, the burden shifts to Registrant to show why
he can be entrusted with a registration. Morall, 412 F.3d. at 174;
Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d
823, 830 (11th Cir. 2018); Garrett Howard Smith, M.D., 83 FR 18882,
18904 (2018); supra section III.
The issue of trust is necessarily a fact-dependent determination
based on the circumstances presented by the individual registrant.
Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also Jones Total
Health Care Pharmacy, 881 F.3d at 833. Moreover, as past performance is
the best predictor of
[[Page 25086]]
future performance, DEA Administrators have required that a registrant
who has committed acts inconsistent with the public interest must
accept responsibility for those acts and demonstrate that he will not
engage in future misconduct. Jones Total Health Care Pharmacy, 881 F.3d
at 833; ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th
Cir. 1995). A registrant's acceptance of responsibility must be
unequivocal. Jones Total Health Care Pharmacy, 881 F.3d at 830-31. In
addition, a registrant's candor during the investigation and hearing
has been an important factor in determining acceptance of
responsibility and the appropriate sanction. Id. Further, the Agency
has found that the egregiousness and extent of the misconduct are
significant factors in determining the appropriate sanction. Id. at 834
& n.4. The Agency has also considered the need to deter similar acts by
the registrant and by the community of registrants. Jeffrey Stein,
M.D., 84 FR 46972-73.
Here, Registrant did not request a hearing and did not otherwise
avail himself of the opportunity to refute the Government's case. As
such, there is no record evidence that Registrant takes responsibility,
let alone unequivocal responsibility, for the founded violations,
meaning, among other things, that it is not reasonable to believe that
Registrant's future controlled substance-related actions will comply
with legal requirements. Accordingly, Registrant did not convince the
Agency that he can be entrusted with a registration.
Further, the interests of specific and general deterrence weigh in
favor of revocation. Given the foundational nature of Registrant's
violations, a sanction less than revocation would send a message to the
existing and prospective registrant community that compliance with the
law is not a condition precedent to maintaining a registration.
In sum, Registrant has not offered any evidence on the record that
rebuts the Government's case for revocation of his registration due to
a material falsification, and Registrant has not demonstrated that he
can be entrusted with the responsibility of registration. Accordingly,
the Agency will order the revocation of Respondent's registration.\7\
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\7\ In this matter there are two separate and distinct grounds
by which the Agency proposed revocation, Registrant's loss of state
authority and his material falsification; each ground, standing
alone, supports the Agency's decision to revoke.
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Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a) and 21 U.S.C. 823(g)(1), I hereby revoke DEA Certificate
of Registration No. BB7959731 issued to James F. Brown, D.P.M. Further,
pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C.
824(a) and 21 U.S.C. 823(g)(1), I hereby deny any pending applications
of James F. Brown, D.P.M., to renew or modify this registration, as
well as any other pending application of James F. Brown, D.P.M., for
additional registration in California. This Order is effective July 14,
2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
June 6, 2025, by Acting Administrator Robert J. Murphy. 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. 2025-10742 Filed 6-12-25; 8:45 am]
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