Notice2025-06453
Victor Augusto Silva, M.D.; Order
Primary source
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Published
April 16, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 90 Issue 72 (Wednesday, April 16, 2025)</title>
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[Federal Register Volume 90, Number 72 (Wednesday, April 16, 2025)]
[Notices]
[Pages 16002-16005]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06453]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Victor Augusto Silva, M.D.; Order
On February 22, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to Victor Augusto Silva, M.D., of Tampa, Florida
(Respondent). Request for Final Agency Action (RFAA), at 1; RFAA
Exhibit (RFAAX) 1, at 1. The OSC/ISO informed Respondent of the
immediate suspension of his DEA Certificate of Registration, No.
FS3590266, pursuant to 21 U.S.C. 824(d), alleging that Respondent's
continued registration constitutes ``an imminent danger to the public
health or safety.'' RFAAX 1, at 1 (quoting 21 U.S.C. 824(d)). The OSC/
ISO also proposed the revocation of Respondent's registration, No.
FS3590266, alleging that Respondent's registration is inconsistent with
the public interest. Id.
More specifically, the OSC/ISO alleged that Respondent allowed an
unauthorized person to use his registration to prescribe controlled
substances in violation of federal regulations and Florida law. RFAAX
1, at 1-3. On April 18, 2024, the Government submitted an RFAA to the
Administrator requesting that the Agency issue a default final order
revoking Respondent's registration. RFAA, at 1.
As a preliminary matter, this decision addresses whether or not
Respondent is in default and finds that he is. Thereafter, the decision
makes specific factual findings on the alleged violations as set forth
in the OSC. Next, the decision considers whether Respondent's continued
registration is inconsistent with the public interest by evaluating the
found violations in the context of the public interest factors. Where,
as here, the Agency determines that Respondent's continued registration
is inconsistent with the public interest, the Respondent is then given
an opportunity to argue for mitigation of the sanction by establishing
that he can be trusted with a registration. After carefully reviewing
the entire record and conducting the analysis as set forth in more
detail below, the Agency grants the Government's request for final
agency action and revokes Respondent's registration.
I. Default Determination
Under 21 CFR 1301.43, a registrant entitled to a hearing who fails
to file a timely hearing request ``within 30 days after the date of
receipt of the [OSC] . . . shall be deemed to have waived their right
to a hearing and to be in default'' unless ``good cause'' is
established for the failure. 21 CFR 1301.43(a) & (c)(1). In the absence
of a demonstration of good cause, a registrant who fails to timely file
an answer also is ``deemed to have waived their right to a hearing and
to be in default.'' 21 CFR 1301.43(c)(2). Unless excused, a default
constitutes ``an admission of the factual allegations of the [OSC].''
21 CFR 1301.43(e).
Here, the OSC/ISO notified Respondent of his right to file with DEA
a written request for a hearing and informed him that if he failed to
file a hearing request or an answer, he would be deemed to have waived
his right to a hearing and be in default. RFAAX 1, at 4. Respondent
requested a hearing on April 2, 2024.\1\ RFAAX 3, at 3. On April 3,
2024, the Government filed proof that it had served the OSC/ISO on
Respondent on February 23, 2024. Government's Notice of Service,
Exhibit A, at 1. Administrative Law Judge (ALJ) Teresa A. Wallbaum
provided a briefing schedule for any Government motions related to the
timeliness of Respondent's hearing request with an opportunity for
Respondent to file a response addressing his reasons for failing to
file the request for a hearing within the time provided by the OSC/ISO.
Briefing Order Regarding Timeliness of Request for Hearing, at 1-2.
Respondent's response to any Government motion was due on April 17,
2024. Id., at 3. On April 4, 2024, the ALJ reminded Respondent of the
filing deadline for his response. Order Regarding Status Conference, at
2. On April 10, 2024, the Government filed a motion to terminate
proceedings.\2\ RFAAX 3, at 1-2; Government's Motion to Terminate
Proceedings, at 1. When Respondent failed to file a response by the
deadline, the ALJ issued an order on April 18, 2024, granting the
Government's motion and terminating the administrative proceedings.
RFAAX 3, at 2, 4.
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\1\ Respondent submitted the hearing request electronically
after 5:00 p.m. on April 1, 2024. Briefing Order Regarding
Timeliness of Request for Hearing, at 1 & n.1 (citing 21 CFR
1316.45).
\2\ The Government submitted the motion after 5:00 p.m. on April
9, 2024; the ALJ deemed it filed the following business day. RFAAX
3, at 2 n.3.
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The Government's RFAA to the Administrator requested that the
Agency issue a final order revoking Respondent's registration on the
basis that his continued registration is inconsistent with the public
interest. RFAA, at 1 (citing 21 U.S.C. 824(a)(4)). The Government
requested final agency action ``pursuant to 21 CFR 1301.43(c) and (f) .
. . , because Respondent has neither timely requested a hearing, nor
provided answers for the [OSC/ISO].'' Id.
Under these facts, the Agency finds that the ALJ's termination of
the proceedings--where Respondent failed to timely file a request for a
hearing and an answer and did not demonstrate good cause for the
failures--was appropriate.\3\ See RFAAX 3, at 3-4 (citing 21 CFR
1301.43(a) & (c)(2)-(f)(1), 1316.47). Thus, the Agency finds that that
Respondent is in default and has admitted to the factual allegations in
the OSC/ISO.\4\ 21 CFR 1301.43(e).
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\3\ Subsequent filings by Respondent, even if viewed as motions
to excuse the default, also fail to establish good cause for the
default. 21 CFR 1301.43(f)(2). Both the OSC/ISO and the Order for
Prehearing Statements provided notice of the requirement to timely
file an answer. Order for Prehearing Statements, at 2; RFAAX 1, at
4.
\4\ The Government's RFAA notes that certain facts alleged in
the OSC/ISO are incorrect and seeks to correct them. RFAA, at 3 n.2.
According to the Government, the timeframe alleged in the OSC of
``June 2023 to December 2023'' should be corrected to ``June 2022,
to December 2023.'' Id. Thus, the Government seeks to expand the
timeframe of one of the two OSC/ISO paragraphs (paragraph five)
containing the details of the allegations of Respondent's unlawful
prescribing of controlled substances. RFAAX 1, at 3. Although the
Government may propose corrections to an OSC during a hearing
process, Judson J. Somerville, M.D., 82 FR 21408, 21408 n.1 (2017)
(correcting registration number), a registrant's deemed ``admission
of the factual allegations'' based on a default applies to the facts
in the OSC only. 21 CFR 1301.43(e) (``A default, unless excused,
shall be deemed to constitute . . . an admission of the factual
allegations of the [OSC].''). Accordingly, the Agency is unable to
deem the modified facts of paragraph five (as proposed by the
Government in the RFAA) to be admitted. Nor will the Agency deem the
original facts in that paragraph to be admitted where, as here, the
Government has asserted that they are incorrect. 21 CFR 1301.43(e).
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II. State and Federal Law Regarding Permitting Unauthorized Use of a
DEA Registration
As the Supreme Court stated in Gonzales v. Raich, 545 U.S. 1
(2005), ``the main objectives of the [Controlled Substances Act (CSA)]
were to conquer drug abuse and control the legitimate and illegitimate
traffic in controlled substances.'' 545 U.S. at 12.
Congress was particularly concerned with the need to prevent the
diversion of drugs from legitimate to illicit channels. To
effectuate these goals, Congress devised a closed regulatory system
making it unlawful to manufacture, distribute, dispense, or possess
any controlled substance except in a manner authorized by the CSA. .
. . The CSA and its implementing regulations set forth strict
requirements regarding registration, labeling and packaging,
production quotas, drug security, and recordkeeping.
Id. at 12-14.
According to the CSA's implementing regulations, prescriptions may
only be issued by an individual practitioner who is ``[a]uthorized to
prescribe controlled substances by the jurisdiction in which he is
licensed to practice his profession'' and has either been issued a DEA
registration or is exempted from registration under DEA regulations. 21
CFR 1306.03. Furthermore, a lawful controlled substance order or
prescription is one that 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). A ``practitioner must
establish and maintain a bona fide doctor-patient relationship in order
to act `in the usual course of . . . professional practice' and to
issue a prescription for a `legitimate medical purpose.' '' Dewey C.
Mackay, M.D., 75 FR 49956, 49973 (2010). When a registrant entrusts his
registration to another person, ``this Agency has long held that a
registrant is strictly liable for [its] misuse.'' Kevin Dennis, M.D.,
78 FR 52787, 52799 (2013).
Similarly, under Florida law, ``[p]rescribing . . . a legend drug,
including any controlled substance, other than in the course of the
physician's professional practice'' is grounds for disciplinary action.
Fla. Stat. section 458.331(1)(q). Moreover, Florida law states that the
act of ``[a]iding, assisting, procuring, or advising any unlicensed
person to practice medicine contrary to [Chapter 458 of Florida
Statutes Title XXXII] or to a rule of the [Department of Health] or the
[Board of Medicine]'' is a basis for disciplinary action of a
physician. Fla. Stat. sections 458.305(a)-(b), 458.331(1)(f). The
practice of medicine includes ``the prescription for any human disease,
pain, injury, deformity, or other physical or mental condition.'' Fla.
Stat. section 458.305(4).
Based on the above, the Agency finds that it is a violation of both
Florida and federal law for a registrant to allow a person who is not
licensed to practice medicine in Florida (and therefore who is not
authorized to prescribe controlled substances in Florida) to issue
prescriptions for controlled substances using their DEA registration.
III. Findings of Fact
In light of Respondent's default, the factual allegations in the
OSC--other than paragraph 5, which the Government asserts was
incorrect, supra n.4--are deemed admitted. 21 CFR 1301.43(e).
Accordingly, the Agency deems as admitted that Respondent allowed B.L.,
the owner of a medical clinic, to prescribe controlled substances using
Respondent's registration in 2023. RFAAX 1, at 3. B.L. was not a
licensed medical professional and was not authorized to perform medical
examinations, make diagnoses, or prescribe controlled substances. Id.
The Respondent continued to allow an unauthorized person to access his
registration outside the usual course of professional practice as
recently as December 2023. Id.
Accordingly, the Agency finds substantial record evidence that in
the year 2023 Respondent allowed a person who was not licensed to
practice medicine, and therefore was not authorized to prescribe
controlled substances, to access his DEA registration and use it to
prescribe controlled substances.
IV. Public Interest Determination
A. Legal Background on Public Interest Determinations
When the CSA's strict requirements are not met, the Attorney
General ``may deny, suspend, or revoke [a] registration if . . . the
[registrant's] registration would be `inconsistent with the public
interest.''' Gonzales v. Oregon, 546 U.S. 243, 251 (2006) (quoting 21
U.S.C. 824(a)(4)). In the case of a ``practitioner,'' Congress directed
the Attorney General to consider five factors in making the public
interest determination. Id.; 21 U.S.C. 823(g)(1)(A-E).\5\
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\5\ The five factors are:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant's] conviction record under Federal or State
laws relating to the 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)(A-E).
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The five factors are considered in the disjunctive. Gonzales v.
Oregon, 546 U.S. at 292-93 (Scalia, J., dissenting) (``It is well
established that these factors are to be considered in the
disjunctive,'' quoting In re Arora, 60 FR 4447, 4448 (1995)); Robert A.
Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor is weighed on a
case-by-case basis. David H. Gillis, M.D., 58 FR 37507, 37508 (1993);
see Morall v. Drug Enf't Admin., 412 F.3d 165, 181 (D.C. Cir. 2005)
(describing the Agency's adjudicative process as ``applying a multi-
factor test through case-by-case adjudication,'' quoting LeMoyne-Owen
Coll. v. N.L.R.B., 357 F.3d 55, 61 (D.C. Cir. 2004)). Any one factor,
or combination of factors, may be decisive, David H. Gillis, M.D., 58
FR 37508, and the Agency ``may give each factor the weight . . .
deem[ed] appropriate in determining whether a registration should be
revoked or an application for registration denied.'' Morall, 412 F.3d.
at 185 n.2 (Henderson, J., concurring) (quoting Robert A. Smith, M.D.,
70 FR 33207, 33208 (2007)); see also Penick Corp. v. Drug Enf't Admin.,
491 F.3d 483, 490 (D.C. Cir. 2007).
Moreover, while the Agency is required to consider each of the
factors, it ``need not make explicit findings as to each one.'' MacKay
v. Drug Enf't Admin., 664 F.3d 808, 816 (10th Cir. 2011) (quoting
Volkman v. U. S. Drug Enf't Admin., 567 F.3d 215, 222 (6th Cir. 2009));
Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d
823, 830 (11th Cir. 2018); Hoxie v. Drug Enf't Admin., 419 F.3d 477,
482 (6th Cir. 2005). ``In short, . . . the Agency is not required to
mechanically count up the factors and determine how many favor the
Government and how many favor the registrant. Rather, it is an inquiry
which focuses on protecting the public interest; what matters is the
seriousness of the registrant's misconduct.'' Jayam Krishna-Iyer, M.D.,
74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has
recognized, Agency decisions have explained that findings under a
single factor can support the
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revocation of a registration. MacKay, 664 F.3d at 821.
B. Respondent's Continued Registration Is Inconsistent With the Public
Interest
While the Agency has considered all the public interest factors of
21 U.S.C. 823(g)(1),\6\ the Government's evidence in support of its
prima facie case for sanction is confined to Factors B and D. RFAAX 1,
at 3. Evidence is considered under Factors B and D when it reflects
compliance or non-compliance with laws related to controlled substances
and experience dispensing controlled substances. Kareem Hubbard, M.D.,
87 FR 21156, 21162 (2022).
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\6\ As to Factor A, there is no record evidence of disciplinary
action against Respondent's state medical license. 21 U.S.C.
823(g)(1)(A). State authority to practice medicine is ``a necessary,
but not a sufficient condition for registration.'' Robert A. Leslie,
M.D., 68 FR 15230. Therefore, ``[t]he fact that the record contains
no evidence of a recommendation by a state licensing board does not
weigh for or against a determination as to whether continuation of
the Respondent's 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 Respondent has
been convicted of any federal or state law offense ``relating to the
manufacture, distribution, or dispensing of controlled substances.''
21 U.S.C. 823(g)(1)(C). However, as Agency cases have noted, ``the
absence of such a conviction is of considerably less consequence in
the public interest inquiry'' and is therefore not dispositive.
Dewey C. MacKay, M.D., 75 FR 49973. 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 Respondent.
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Here, the Respondent's conduct reflects negative experience in
prescribing with respect to controlled substances. See supra Section
III. Moreover, the Agency found substantial record evidence that in the
year 2023 Respondent allowed a person who was not licensed to practice
medicine, and therefore was not authorized to prescribe controlled
substances, to access his DEA registration and use it to prescribe
controlled substances. Accordingly, there is substantial record
evidence in support of the Agency's finding that in 2023 Respondent
committed violations of both Florida state law and federal controlled
substance regulations, namely 21 CFR 1306.04(a) and Fla. Stat. section
458.331(f).
The Agency further finds that after balancing the factors of 21
U.S.C. 823(g)(1), Respondent's continued registration would be
``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4).
Accordingly, the Government satisfied its prima facie burden of showing
that Respondent's continued registration would be ``inconsistent with
the public interest.'' 21 U.S.C. 824(a)(4). The Agency also finds that
there is insufficient mitigating evidence to rebut the Government's
prima facie case. Thus, the only remaining issue is whether, in spite
of the public interest determination, Respondent can be trusted with a
registration.
V. Sanction
Where, as here, the Government has met the burden of showing that
Respondent's continued registration is inconsistent with the public
interest, the burden shifts to Respondent 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). The
issue of trust is necessarily a fact-dependent determination based on
the circumstances presented by the individual respondent. 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 future performance, the Agency requires that a
registrant who has committed acts inconsistent with the public interest
accept responsibility for those acts and demonstrate that it will not
engage in future misconduct. See 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). The Agency requires a registrant's unequivocal
acceptance of responsibility. Janet S. Pettyjohn, D.O., 89 FR 82639,
82641 (2024); Mohammed Asgar, M.D., 83 FR 29569, 29573 (2018); see also
Jones Total Health Care Pharmacy, 881 F.3d at 830-31. In addition, a
registrant's candor during the investigation and hearing is an
important factor in determining acceptance of responsibility and the
appropriate sanction. See Jones Total Health Care Pharmacy, 881 F.3d at
830-31; Hoxie, 419 F.3d at 483-84. Further, the Agency considers the
egregiousness and extent of the misconduct as significant factors in
determining the appropriate sanction. See Jones Total Health Care
Pharmacy, 881 F.3d at 834 & n.4. The Agency also considers the need to
deter similar acts by the respondent and by the community of
registrants. Jeffrey Stein, M.D., 84 FR 46972-73.
Here, Respondent filed an untimely hearing request, did not file an
answer, and was found to be in default. RFAAX 3, at 3-4. Thus, there is
no record evidence that Respondent takes responsibility, let alone
unequivocal responsibility, for the misconduct. Accordingly, he has not
convinced the Agency that his future controlled-substance-related
actions will comply with the CSA such that he can be entrusted with the
responsibilities of a registration.
Further, the interests of specific and general deterrence weigh in
favor of revocation. Respondent's conduct in this matter concerns the
CSA's ``strict requirements regarding registration'' and, therefore,
goes to the heart of the CSA's ``closed regulatory system''
specifically designed ``to conquer drug abuse and to control the
legitimate and illegitimate traffic in controlled substances.''
Gonzales v. Raich, 545 U.S. 1, 12-14 (2005). To permit Respondent to
continue to maintain a registration under these circumstances would
send a dangerous message that compliance with the law is not essential
to maintaining a registration.
In sum, Respondent has not offered any credible evidence on the
record that rebuts the Government's case for revocation of his
registration, and Respondent has not demonstrated that he can be
entrusted with the responsibility of registration. Accordingly, the
Agency will order the revocation of Respondent's registration.
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. FS3590266 issued to Victor Augusto Silva, M.D.
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 other
pending application of Victor Augusto Silva, M.D., for registration in
Florida. This Order is effective May 16, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
April 10, 2025, by Acting Administrator Derek Maltz. 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
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the legal effect of this document upon publication in the Federal
Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-06453 Filed 4-15-25; 8:45 am]
BILLING CODE 4410-09-P
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