George D. Gowder, III, M.D.; Decision and Order, 76152-76156 [2024-21051]
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Drug
code
Controlled substance
Thebaine ......................................................................................................................................................................................
Dihydroetorphine .........................................................................................................................................................................
Levo-alphacetylmethadol .............................................................................................................................................................
Oxymorphone ..............................................................................................................................................................................
Noroxymorphone .........................................................................................................................................................................
Phenazocine ................................................................................................................................................................................
Thiafentanil ..................................................................................................................................................................................
Piminodine ...................................................................................................................................................................................
Racemethorphan .........................................................................................................................................................................
Racemorphan ..............................................................................................................................................................................
Alfentanil ......................................................................................................................................................................................
Remifentanil .................................................................................................................................................................................
Sufentanil .....................................................................................................................................................................................
Carfentanil ...................................................................................................................................................................................
Tapentadol ...................................................................................................................................................................................
Bezitramide ..................................................................................................................................................................................
Fentanyl .......................................................................................................................................................................................
Moramide-intermediate ................................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances for distribution to its
customers. In reference to dug codes
7360 (Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–21062 Filed 9–16–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1432]
Bulk Manufacturer of Controlled
Substances Application: Eli-Elsohly
Laboratories
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on August 16, 2024, EliElsohly Laboratories, 5 Industrial Park
Drive, Oxford, Mississippi 38655–5343,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
AGENCY:
Eli-Elsohly Laboratories has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUPPLEMENTARY INFORMATION listed
below for further drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before November 18, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 18, 2024.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
SUMMARY:
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Controlled substance
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Marihuana Extract ..........
Marihuana .......................
Tetrahydrocannabinols ...
Dihydromorphine ............
Amphetamine .................
Methamphetamine ..........
Cocaine ..........................
Codeine ..........................
Dihydrocodeine ...............
Oxycodone .....................
Ecgonine .........................
Thebaine .........................
Drug
code
Schedule
7350
7360
7370
9145
1100
1105
9041
9050
9120
9143
9180
9333
I
I
I
I
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances for
product development reference
standards. In reference to drug codes
7360 (Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to isolate these controlled
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9333
9334
9648
9652
9668
9715
9729
9730
9732
9733
9737
9739
9740
9743
9780
9800
9801
9802
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
substances from procured 7350
(Marihuana Extract). In reference to
drug code 7360, no cultivation activities
are authorized for this registration.
In reference to drug code 9333
(Thebaine), the company plans to
manufacture a Thebaine derivative. No
other activities for these drug codes are
authorized for this registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–21060 Filed 9–16–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 23–53]
George D. Gowder, III, M.D.; Decision
and Order
On July 18, 2023, the Drug
Enforcement Administration (DEA or
Government) issued an Order to Show
Cause (OSC) to George Gowder, III,
M.D., of Blairsville, Georgia
(Respondent). OSC, at 1, 3. The OSC
proposed the denial of Respondent’s
application for a DEA Certificate of
Registration (registration), Control No.
W22147308C, alleging that Respondent
has been convicted of a felony relating
to Federal controlled substance laws,
and that he has been excluded from
participation in Medicare, Medicaid,
and all Federal health care programs. Id.
at 1–2 (citing 21 U.S.C. 823(g)(1),
824(a)(2), 824(a)(5)).
A hearing was held before DEA
Administrative Law Judge Teresa A.
Wallbaum (ALJ), who, on December 1,
2023, issued her Recommended Rulings,
Findings of Fact, Conclusions of Law,
and Decision (Recommended Decision
or RD). The RD recommended that
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Respondent’s application be granted
with restrictions.1 RD, at 20–21. The
Government filed Exceptions to the RD.
Having reviewed the entire record, the
Agency adopts and hereby incorporates
by reference the entirety of the ALJ’s
rulings, credibility findings,2 findings of
fact, and conclusions of law, and
expands upon portions thereof herein.
However, the Agency has determined
based on Respondent’s unequivocal
acceptance of responsibility and his
fulsome demonstration of remediation
that Respondent can be trusted with an
unencumbered registration for
Schedules III through V.
I. Findings of Fact
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A. Felony Conviction
On June 10, 2020, Respondent pled
guilty to one count of ‘‘Dispensing
Controlled Substances Outside
Professional Practice’’ in violation of 21
U.S.C. 841(a) and 841(b)(1)(C), and he
was sentenced to 18 months in prison.
RX 2, at 1; RD, at 8; Tr. 8. After serving
15 months in prison, he was placed on
two years of supervised release. RD, at
8; Tr. 89–91. Respondent served one
year of supervised release, but was
released from the second. RD, at 8; Tr.
91–92.
Respondent’s Federal conviction was
the culmination of more than a decade
of diverting controlled substances for
personal use.3 RD, at 5–6. Respondent
testified that he began taking opioids in
the early 2000s after they were lawfully
prescribed for a back injury. Id. at 6; Tr.
55. Respondent testified that, after
1 The ALJ recommended that Respondent be
required to submit to regular drug testing, refrain
from taking controlled substances that are not
lawfully prescribed, and hire a practice monitor to
monitor his prescribing practices and submit
regular reports to DEA. RD, at 20–21. The ALJ also
recommended that Respondent’s registration be
limited to Schedules III through V. Id. As noted
herein, Respondent only applied for authority in
Schedules III through V.
2 The Agency adopts the ALJ’s summary of each
of the witnesses’ testimonies as well as the ALJ’s
assessment of each of the witnesses’ credibility. See
RD, at 3–10. The Agency agrees with the ALJ that
the testimony from the DEA Diversion Investigator
(DI), which was primarily focused on the
introduction of the Government’s documentary
evidence, was ‘‘sufficiently detailed, plausible, and
internally consistent to be afforded full credibility.’’
Id. at 5.
3 The Agency agrees with the ALJ that
‘‘Respondent testified clearly, candidly, and
without hesitation,’’ notwithstanding that he
‘‘unarguably possesses . . . the greatest motivation
to enhance, modify, or even fabricate his
testimony.’’ RD, at 9. Respondent ‘‘did not shy away
from difficult questions and his answers contained
no caveats or attempts to minimize his behavior,’’
and in fact, the primary details regarding his
fraudulent conduct came from Respondent’s
testimony and exhibits. Id. at 9–10. Therefore, the
Agency agrees with the ALJ that Respondent’s
testimony should be ‘‘afforded full credibility.’’ Id.
at 10.
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finishing that prescription, he would
occasionally ‘‘reward’’ himself by taking
an opiate sample from the emergency
room where he worked. RD, at 6; Tr. 55–
56, 59. He would take an opiate once a
month, which then progressed to once
every two weeks. RD, at 6; Tr. 58–59.
Respondent testified that his
progression ‘‘from a user to an addict’’
took at least two or three years. RD, at
6; Tr. 59–60. Respondent abused
oxycodone and hydrocodone in pill
form. Id. Respondent testified that when
he became addicted to opiates, he
‘‘started doing things [he] would never
ha[ve] thought [he] would do,’’
including forging prescriptions and
stealing drugs from patients. RD, at 6;
Tr. 60. Respondent explained that he
forged prescriptions in two different
ways. RD, at 7–8; Tr. 85. First, he wrote
prescriptions for himself and forged
another physician’s name and DEA
number. Id. Second, he wrote
prescriptions purportedly for a
homebound patient, went to the
pharmacy to have the prescriptions
filled, and used the drugs himself. RD,
at 8; Tr. 85–86.
Respondent’s misconduct led to a
series of arrests by local law
enforcement in 2015 and 2016, which
resulted in charges for prescription
forgery. RD, at 6–7; Tr. 62–68. After the
first arrest in April of 2015, Respondent
entered a residential treatment center
for three months, and has remained
drug-free since. See supra III.B; RD, at
8; Tr. 93. While in recovery, local law
enforcement referred his case to Federal
law enforcement and Federal charges
were brought. RD, at 7; Tr. 69–70.
Respondent ultimately pled guilty and
was federally convicted in June of 2020.
RD, at 7; Tr. 64, 70, 79.
B. Exclusion From Medicare
The Department of Health and Human
Services (HHS) notified Respondent by
letter on October 29, 2021, that he
would be ‘‘exclud[ed] from participation
in all Federal health care programs . . .
for a minimum period of [seven] years.’’
GX 3, at 1. The letter notified
Respondent that the exclusion was a
result of Respondent’s ‘‘felony
conviction . . . related to the unlawful
manufacture, distribution, prescription,
or dispensing of a controlled
substance.’’ Id. The letter also notified
Respondent that his period of exclusion
exceeded the minimum exclusion
period of five years because his criminal
sentence included prison time, and
because the Georgia Composite Medical
Board (Medical Board) had taken
additional adverse action against
Respondent by suspending his medical
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license.4 Id. HHS considered these
factors to be ‘‘aggravating
circumstances.’’ Id. The seven-year
exclusion period became effective on
November 18, 2021. Id.
II. Discussion
The Government alleged two
independent grounds for denial: (1) that
Respondent has been convicted of a
felony relating to controlled substances,
21 U.S.C. 824(a)(2), 823(g)(1), and (2)
that Respondent has been excluded
from participation in all Federal health
care programs, id. sections 824(a)(5),
823(g)(1). OSC, at 1–2. Having reviewed
the record and the RD, the Agency
agrees with the ALJ, adopts the ALJ’s
analysis, and finds that the Government
has satisfied its prima facie burden of
demonstrating that both grounds for
denial exist. Id. at 10–12.
A. Felony Conviction
Pursuant to 21 U.S.C. 824(a)(2), the
Attorney General is authorized to
suspend or revoke a registration issued
under section 823 of the Controlled
Substances Act (CSA) ‘‘upon a finding
that the registrant . . . has been
convicted of a felony . . . relating to
any . . . controlled substance.’’ 21
U.S.C. 824(a)(2). The Agency has
consistently held that it also may deny
an application for a DEA registration
upon finding that the registrant has been
convicted of a felony relating to
controlled substances. Arvinder Singh,
M.D., 81 FR 8247, 8248 n.3 (2016)
(quoting Kwan Bo Jin, M.D., 77 FR
35021, 35021 n.2 (2012)) (‘‘[W]here a
registration can be revoked under [21
U.S.C.] 824, it can, a fortiori, be denied
under [21 U.S.C. ] 823 since the law
would not require an agency to indulge
in the useless act of granting a license
on one day only to withdraw it on the
next.’’). Here, the undisputed and
substantial record evidence
demonstrates that Respondent has been
convicted of a felony relating to
controlled substances. OSC, at 10–11.
RD, at 11; GX 2; RX 1, at 3–4; Tr. 87–
88.
B. Exclusion From Medicare
Respondent’s application also may be
denied ‘‘upon a finding that the
registrant . . . has been excluded (or
directed to be excluded) from
participation in a program pursuant to
section 1320a–7(a) of Title 42.’’ 21
U.S.C. 824(a)(5), 823(g)(1); Arvinder
Singh, 81 FR 8248 n.3. Here, the
undisputed and substantial record
evidence demonstrates that HHS
4 Respondent regained his state medical license in
October of 2022. RD, at 6; Tr. 53.
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mandatorily excluded Registrant from
‘‘all Federal health care programs’’
under 42 U.S.C. 1320a–7(a)(4). RD, at
11; GX 3; ALJX 14, at 2; Tr. 30–31.
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III. Sanction
Where, as here, the Government has
established sufficient grounds to deny a
Respondent’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, 18904 (2018).
When a registrant has committed acts
inconsistent with the public interest, he
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). 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 33738, 33746 (2021).
A. Acceptance of Responsibility
Here, the Agency agrees with the ALJ
that Respondent unequivocally accepted
responsibility for his conduct. RD, at
12–14. Respondent took every
opportunity to acknowledge that his
conduct was wrong and he made no
efforts to minimize it. Id. at 13. He
admitted that he was guilty of
dispensing controlled substances
outside of his professional practice
because he forged prescriptions and
fraudulently filled his patients’
prescriptions for his own use. RD, at 13;
Tr. 84–85. Respondent testified that he
did not want to defend or glorify his
conduct, and stated that ‘‘it is a
shameful, morally bad place to be.’’ RD,
at 13; Tr. 56, 84–86. He also
acknowledged that he ‘‘abused the
public trust as a physician.’’ RD, at 13;
Tr. 83. Respondent testified that he has
‘‘been completely honest’’ about his
behavior and conduct ‘‘with every
single person that [he has] spoken to
whether it’s law enforcement, whether
in the legal system, [or] in treatment.’’
Tr. 89–90. Respondent testified that the
judge presiding over his criminal
sentencing hearing ‘‘spoke highly’’ of
him, and noted his acceptance of
responsibility and willingness to
cooperate.5 RD, at 8; Tr. 80.
5 Respondent’s credible, unchallenged testimony
regarding his acceptance of responsibility in his
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Accordingly, the Agency agrees with the
ALJ that Respondent unequivocally
accepted responsibility for his
misconduct,6 RD, at 12–14, and
commends Respondent for his
willingness to candidly reflect on his
battle with addiction in a public forum.
B. Remedial Measures
Having found that Respondent has
unequivocally accepted responsibility
for his conduct, the Agency considers
whether Respondent has implemented
sufficient remedial measures to
demonstrate that he will not engage in
future misconduct and can be trusted
with a registration. Jayam Krishna-Iyer,
M.D., 74 FR 459, 463 (2009). The
Agency has acknowledged that ‘‘[i]n
self-abuse cases, . . . successful
rehabilitation efforts are an important
consideration in determining whether a
respondent can be trusted with a
registration.’’ Trenton F. Horst, D.O., 80
FR 41079, 41091 (2015); see also Abbas
E. Sina, M.D., 80 FR 53191, 53201
(2015) (‘‘[T]he risk of relapse becomes
critical in determining what steps are
warranted when determining the public
interest.’’).
Respondent provided extensive
testimony regarding his recovery and
his efforts to remain sober. RD, at 15; Tr.
106–108, 109–110. After his first arrest
in April of 2015, he entered a residential
treatment center for three months. RD,
at 8; Tr. 93. He went into treatment
partially because he knew he would not
be able to regain his medical license
without receiving treatment. RD, at 8;
Tr. 94–95. After completing residential
treatment, Respondent entered a
‘‘Chemical Addiction Monitoring
Agreement’’ with the Georgia
Professional Health Program (PHP). RD,
at 8–9; RX 2, at 1. The agreement
required him to submit to random drug
tests and attend self-help meetings,
small-group counseling sessions, and
meetings with other physicians in the
PHP. RD, at 9; Tr. 96–97; RX 2, at 1–3.
The initial agreement lasted for five
years, and he completed it before
entering Federal prison in July of 2020.
RD, at 9; Tr. 107–09; RX 2, at 1.
Respondent was not monitored by the
PHP during his incarceration. RD, at 9;
Tr. 108–109. Respondent entered a
second agreement with the PHP in
criminal proceedings weighs in his favor. See
Michele L. Martinho, M.D., 86 FR 24012, 24020 n.*E
(2021) (citing Mohammed Asgar, 83 FR 29569,
29573 n.3 (2018)) (An AUSA or Judge’s comments
regarding a respondent’s acceptance of
responsibility during criminal proceedings are not
binding on the Agency, but they are relevant
evidence).
6 The Government seems to acknowledge in its
Post-hearing Brief that Respondent accepted
responsibility for his conduct. ALJX 23, at 25.
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September of 2022, which required him
to continue to attend various meetings
and submit to random drug tests. RD, at
9; Tr. 107–08; RX 2, at 9–17.
Respondent testified that he entered the
new agreement because he wanted ‘‘to
do whatever [the] Georgia PHP felt was
needed for [him] to be a reliable
physician,’’ but that he also had an
‘‘overwhelming desire not to fall back
into addiction.’’ RD, at 15; Tr. 106.
Because Respondent does ‘‘a good bit’’
more than is required by the Georgia
PHP agreement, he was recently
transitioned to a ‘‘senior monitoring
agreement,’’ which still requires him to
submit to random drug tests. RD, at 9,
15; Tr. 111–12.
Respondent testified that he plans to
remain under the supervision of the
Georgia PHP even if he is no longer
required to do so to maintain his
medical license. RD, at 15; Tr. 112. He
also plans to continue taking random
drug tests, because even though there is
‘‘no part of [him] that wants to take a
drug[,] . . . the statistics [are] brutal on
relapses,’’ so he ‘‘[cannot] imagine what
would possess [him] to not continue to
be accountable to a urine drug test.’’ RD,
at 15–16; Tr. 112. Respondent testified
that drug testing is one of the best tools
to reduce the likelihood of remission.
RD, at 16; Tr. 112. Respondent testified
that he has taken hundreds of drug tests,
and that there has only been one onemonth period since April of 2015 that
he has not been subject to random drug
tests. Tr. 97. Respondent testified that
he has never failed a drug test and that
he has remained drug-free since
entering treatment in April of 2015. Id.
Perhaps the most concrete remedial
measure that Respondent has taken—
which addresses both his addiction and
the prescription forgery—is that he
applied for a registration to dispense
drugs only in Schedules III through V.
Id. at 16; Tr. 37; 114–115; GX 4, at 1.
Respondent testified that he does not
want authority to prescribe Schedule II
drugs because those are the drugs that
he previously abused. RD, at 16; Tr. 85–
86, 114–115.
Respondent believes that he can be
trusted with a registration because of his
understanding of addiction and his
understanding of how doctors can abuse
their power to write prescriptions. RD,
at 16; Tr. 119. According to Respondent,
with this knowledge, he is safer writing
prescriptions than the majority of
physicians. Id. Respondent requests
authority to prescribe controlled
substances in Schedules III through V so
that he can work in an inpatient
treatment facility that manages medical
detoxification and treats patients with
ongoing chronic illnesses, such as
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diabetes or mental health issues. RD, at
6; Tr. 58, 124. Respondent currently
volunteers as a physician at a long-term
recovery center where he is not required
to possess a DEA registration. RD, at 5;
Tr. 57, 123.
Analysis of Respondent’s remedial
measures is particularly complex. On
one hand, the weight of the remedial
evidence is reduced because the
measures were not implemented until
after Respondent was arrested, and
many of these measures are mandatory
under an agreement with the Medical
Board.7 RD, at 15; Tr. 107. On the other
hand, Respondent has made a sincere
commitment to remaining drug-free for
himself and for his family, and has gone
above and beyond the Medical Board’s
requirements to ensure he does so. RD,
at 15; Tr. 111. For example,
Respondent’s application seeks only to
handle drugs in Schedules III through V
to ensure that he does not have access
to the Schedule II drugs that he abused
in the past. RD, at 16; Tr. 85–86, 114–
115. With these extensive remedial
measures Respondent has remained
sober for approximately nine years.
Accordingly, the ALJ found, and the
Agency agrees, that Respondent can be
trusted with a DEA registration. RD, at
16.
C. Deterrent Effect and Egregiousness
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Acceptance of responsibility and
remedial measures are assessed in the
context of the ‘‘egregiousness of the
violations and the [DEA’s] interest in
deterring similar misconduct by [the]
Respondent in the future as well as on
the part of others.’’ Daniel A. Glick,
D.D.S., 80 FR 74800, 74810 (2015);
OakmontScript Limited Partnership, 87
FR 21516, 21545 (2022). Because these
administrative proceedings are intended
to be remedial, rather than punitive, the
Agency has previously found that,
under appropriate circumstances,
‘‘criminal convictions and sanctions by
state licensing authorities can
sufficiently deter physicians from
7 The Agency has held that remedial measures are
given ‘‘limited-to-no-weight’’ when they are
implemented after enforcement begins. See, e.g.,
Morris & Dickson Co., LLC, 88 FR 34523, 34539–40
(2023) (citing Mireille Lalanne, M.D., 78 FR 47750,
47777 (2013) (‘‘The Agency has recognized that a
cessation of illegal behavior only when ‘DEA comes
knocking at one’s door,’ can be afforded a
diminished weight borne of its own opportunistic
timing.’’); Southwood Pharmaceuticals, Inc., 72 FR
36487, 36503 (2007) (giving no weight to
respondent’s ‘‘stroke-of-midnight decision’’ to cease
supplying suspect pharmacies with controlled
substances and to employ a compliance officer).
This principle applies in even greater force here,
where the remedial measures that Respondent has
implemented appear to be mandatory under an
agreement with the state medical board, rather than
voluntary.
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engaging in misconduct, making the
denial of an application . . .
unnecessary to achieve the goal of
general deterrence.’’ Gilbert Y. Kim,
D.D.S., 87 FR 21139, 21145 (2022)
(citing Kansky J. Delisma, M.D., 85 FR
23845, 23854 (2020)). The Agency has
also held that, sometimes, ‘‘such
punitive measures can suffice to deter
the registrant or applicant from future
misconduct, making revocation or
denial of an application unnecessary to
achieve specific deterrence.’’ Id.
Here, the Agency does not find that
imposing a sanction is necessary to
deter Respondent from engaging in
future misconduct. Respondent has
already faced significant legal
consequences for his misconduct,
including multiple arrests, jailtime,
supervised release, and the loss of his
state medical license and DEA
registration. Respondent has also
undergone significant monitoring to
recover and maintain his state medical
license, including taking hundreds of
random drug tests and attending
frequent substance abuse meetings. RD,
at 9; Tr. 96–97; RX 2, at 1–3.
Respondent testified that the
consequences of his unlawful behavior
have hurt him and his family. Tr. 131.
Thus, the Agency finds that the
punitive, remedial, and personal
consequences that Respondent has
suffered are sufficient to deter him from
engaging in future misconduct,
especially given Respondent’s strong
personal and professional commitment
to remaining drug-free. Respondent’s
commitment to sobriety is a strong
deterrent to future misconduct, as
Respondent testified that the only
reason that he engaged in the fraudulent
conduct that led to the felony
conviction and Medicare exclusion was
to feed his personal addiction. RD, at 6;
Tr. 60. Respondent’s decision not to
request authority to prescribe the
Schedule II drugs that he previously
abused is also a significant deterrent.
RD, at 16; Tr. 85–86, 114–115.
Moreover, there is no evidence that
Respondent has committed any
additional CSA violations since entering
treatment in April of 2015, which
bolsters the Agency’s conclusion that
Respondent has been sufficiently
deterred from future violations.
The Agency also finds that the
significant consequences that
Respondent has faced are sufficient to
deter the general registrant community
from committing similar misconduct of
forging prescriptions and diverting
controlled substances for personal use.
This Decision should signal to the
registrant community that CSA
violations are likely to result in serious
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legal consequences—as Respondent
confronted a protracted legal battle with
local and Federal law enforcement, state
regulators, and DEA as a result of his
misconduct. But this Decision should
also demonstrate to registrants
recovering from addiction that, by
accepting responsibility, remediating
their actions, demonstrating sustained
success with sobriety and conveying a
strong commitment to remaining sober,
cooperating with state and Federal
enforcers, and demonstrating candor
during enforcement proceedings, they
may be shown leniency.
Regarding egregiousness, there is no
dispute that the conduct that led to
Respondent’s conviction and
subsequent exclusion from all Federal
health care programs was egregious.8
RD, at 17. Respondent admitted to using
extra samples at the hospital where he
worked, forging prescriptions using
other physicians’ DEA registrations, and
writing prescriptions with his own DEA
registration purportedly for home-bound
patients. Id. Indeed, such cases of fraud
and forgery are particularly egregious
because Respondent used his
knowledge as a DEA registrant to
circumvent the closed system of
distribution, and he diverted powerful
Schedule II controlled substances. Id.
‘‘These are actions that strike at the very
heart of the responsibilities entrusted to
a DEA registrant . . . .’’ Id. (citing Jana
Marjenhoff, D.O., 80 FR 29067, 29095
(2015)).
However, the evidence
overwhelmingly suggests that
Respondent has unequivocally accepted
responsibility, is remorseful for his
conduct, has taken efforts to help others
recover from addiction, and
rehabilitated himself even before he was
convicted and required to serve his
time. He has also taken steps to reduce
the likelihood of recurrence by limiting
his application to drugs in Schedules III
through V that he has never abused. In
other words, Respondent has presented
convincing evidence to demonstrate that
the Agency can trust him with a
registration.9 Therefore, the Agency will
grant his application.
8 The Government argues in its Exceptions that
‘‘the egregiousness of Respondent’s conduct
supports denial and outweighs any acceptance of
responsibility or proposed remedial measures.’’
Government’s Exceptions, at 4. The Agency agrees
with the Government that Respondent’s conduct
was egregious, but finds that other factors discussed
throughout this Decision obviate the need for a
sanction in this case.
9 For all of the reasons set forth herein, the
Agency finds that it can fully trust Respondent with
a registration. The Agency therefore finds that the
ALJ’s recommended conditions on Respondent’s
registration are unnecessary. RD, at 20–21.
E:\FR\FM\17SEN1.SGM
Continued
17SEN1
76156
Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C. 823
and 824, I hereby dismiss the Order to
Show Cause issued to George Gowder,
III, M.D., and grant Respondent’s
application number W22147308C in
Schedules III through V. This Order is
effective immediately.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on September 11, 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. 2024–21051 Filed 9–16–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Electrical
Standards for Construction and
General Industry
Notice of availability; request
for comments.
ACTION:
The Department of Labor
(DOL) is submitting this Occupational
Safety & Health Administration (OSHA)sponsored information collection
request (ICR) to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995
(PRA). Public comments on the ICR are
invited.
DATES: The OMB will consider all
written comments that the agency
receives on or before October 17, 2024.
ADDRESSES: Written comments and
recommendations for the proposed
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
However, the Agency’s trust can be lost in the event
of a relapse, so the Agency encourages Respondent
to stick to his plan to continue taking random drug
tests. As Respondent testified, ‘‘the statistics [are]
brutal on relapses,’’ and drug testing is one of the
best tools to reduce the likelihood of remission. RD,
at 15–16; Tr. 112.
VerDate Sep<11>2014
17:12 Sep 16, 2024
Jkt 262001
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Nicole Bouchet by telephone at 202–
693–0213, or by email at DOL_PRA_
PUBLIC@dol.gov.
The
information collection requirements
specified in the Electrical Standards for
Construction and General Industry are
necessary for the prevention of
inadvertent electrocution of workers.
These provisions require labels,
markings, written programs,
notifications, and tags to alert workers
of the presence and the different types
of electrical hazards found in the
workplace, thereby, preventing serious
injuries and deaths from electrocutions.
For additional substantive information
about this ICR, see the related notice
published in the Federal Register on
July 1, 2024 (89 FR 54540).
Comments are invited on: (1) whether
the collection of information is
necessary for the proper performance of
the functions of the Department,
including whether the information will
have practical utility; (2) the accuracy of
the agency’s estimates of the burden and
cost of the collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility and
clarity of the information collection; and
(4) ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
automated collection techniques or
other forms of information technology.
This information collection is subject
to the PRA. A Federal agency generally
cannot conduct or sponsor a collection
of information, and the public is
generally not required to respond to an
information collection, unless the OMB
approves it and displays a currently
valid OMB Control Number. In addition,
notwithstanding any other provisions of
law, no person shall generally be subject
to penalty for failing to comply with a
collection of information that does not
display a valid OMB Control Number.
See 5 CFR 1320.5(a) and 1320.6.
DOL seeks PRA authorization for this
information collection for three (3)
years. OMB authorization for an ICR
cannot be for more than three (3) years
without renewal. The DOL notes that
information collection requirements
submitted to the OMB for existing ICRs
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
receive a month-to-month extension
while they undergo review.
Agency: DOL–OSHA.
Title of Collection: Electrical
Standards for Construction and General
Industry.
OMB Control Number: 1218–0130.
Affected Public: Private Sector—
Businesses or other for-profits.
Total Estimated Number of
Respondents: 970,289.
Total Estimated Number of
Responses: 2,979,332.
Total Estimated Annual Time Burden:
210,693 hours.
Total Estimated Annual Other Costs
Burden: $15,835,311.
(Authority: 44 U.S.C. 3507(a)(1)(D))
Nicole Bouchet,
Senior Paperwork Reduction Act Analyst.
[FR Doc. 2024–21020 Filed 9–16–24; 8:45 am]
BILLING CODE 4510–26–P
DEPARTMENT OF LABOR
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Slings
Standard
Notice of availability; request
for comments.
ACTION:
The Department of Labor
(DOL) is submitting this Occupational
Safety and Health Administration
(OSHA)-sponsored information
collection request (ICR) to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995
(PRA). Public comments on the ICR are
invited.
DATES: The OMB will consider all
written comments that the agency
receives on or before October 17, 2024.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Michelle Neary by telephone at 202–
693–6312, or by email at DOL_PRA_
PUBLIC@dol.gov.
SUPPLEMENTARY INFORMATION: The
provisions of the standard require that
the employer make a periodic
inspection of alloy steel chain slings at
least once a year and to make and
maintain a record of the inspection. It
also requires the employer to ensure
SUMMARY:
E:\FR\FM\17SEN1.SGM
17SEN1
Agencies
[Federal Register Volume 89, Number 180 (Tuesday, September 17, 2024)]
[Notices]
[Pages 76152-76156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21051]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 23-53]
George D. Gowder, III, M.D.; Decision and Order
On July 18, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to George Gowder, III,
M.D., of Blairsville, Georgia (Respondent). OSC, at 1, 3. The OSC
proposed the denial of Respondent's application for a DEA Certificate
of Registration (registration), Control No. W22147308C, alleging that
Respondent has been convicted of a felony relating to Federal
controlled substance laws, and that he has been excluded from
participation in Medicare, Medicaid, and all Federal health care
programs. Id. at 1-2 (citing 21 U.S.C. 823(g)(1), 824(a)(2),
824(a)(5)).
A hearing was held before DEA Administrative Law Judge Teresa A.
Wallbaum (ALJ), who, on December 1, 2023, issued her Recommended
Rulings, Findings of Fact, Conclusions of Law, and Decision
(Recommended Decision or RD). The RD recommended that
[[Page 76153]]
Respondent's application be granted with restrictions.\1\ RD, at 20-21.
The Government filed Exceptions to the RD. Having reviewed the entire
record, the Agency adopts and hereby incorporates by reference the
entirety of the ALJ's rulings, credibility findings,\2\ findings of
fact, and conclusions of law, and expands upon portions thereof herein.
However, the Agency has determined based on Respondent's unequivocal
acceptance of responsibility and his fulsome demonstration of
remediation that Respondent can be trusted with an unencumbered
registration for Schedules III through V.
---------------------------------------------------------------------------
\1\ The ALJ recommended that Respondent be required to submit to
regular drug testing, refrain from taking controlled substances that
are not lawfully prescribed, and hire a practice monitor to monitor
his prescribing practices and submit regular reports to DEA. RD, at
20-21. The ALJ also recommended that Respondent's registration be
limited to Schedules III through V. Id. As noted herein, Respondent
only applied for authority in Schedules III through V.
\2\ The Agency adopts the ALJ's summary of each of the
witnesses' testimonies as well as the ALJ's assessment of each of
the witnesses' credibility. See RD, at 3-10. The Agency agrees with
the ALJ that the testimony from the DEA Diversion Investigator (DI),
which was primarily focused on the introduction of the Government's
documentary evidence, was ``sufficiently detailed, plausible, and
internally consistent to be afforded full credibility.'' Id. at 5.
---------------------------------------------------------------------------
I. Findings of Fact
A. Felony Conviction
On June 10, 2020, Respondent pled guilty to one count of
``Dispensing Controlled Substances Outside Professional Practice'' in
violation of 21 U.S.C. 841(a) and 841(b)(1)(C), and he was sentenced to
18 months in prison. RX 2, at 1; RD, at 8; Tr. 8. After serving 15
months in prison, he was placed on two years of supervised release. RD,
at 8; Tr. 89-91. Respondent served one year of supervised release, but
was released from the second. RD, at 8; Tr. 91-92.
Respondent's Federal conviction was the culmination of more than a
decade of diverting controlled substances for personal use.\3\ RD, at
5-6. Respondent testified that he began taking opioids in the early
2000s after they were lawfully prescribed for a back injury. Id. at 6;
Tr. 55. Respondent testified that, after finishing that prescription,
he would occasionally ``reward'' himself by taking an opiate sample
from the emergency room where he worked. RD, at 6; Tr. 55-56, 59. He
would take an opiate once a month, which then progressed to once every
two weeks. RD, at 6; Tr. 58-59. Respondent testified that his
progression ``from a user to an addict'' took at least two or three
years. RD, at 6; Tr. 59-60. Respondent abused oxycodone and hydrocodone
in pill form. Id. Respondent testified that when he became addicted to
opiates, he ``started doing things [he] would never ha[ve] thought [he]
would do,'' including forging prescriptions and stealing drugs from
patients. RD, at 6; Tr. 60. Respondent explained that he forged
prescriptions in two different ways. RD, at 7-8; Tr. 85. First, he
wrote prescriptions for himself and forged another physician's name and
DEA number. Id. Second, he wrote prescriptions purportedly for a
homebound patient, went to the pharmacy to have the prescriptions
filled, and used the drugs himself. RD, at 8; Tr. 85-86.
---------------------------------------------------------------------------
\3\ The Agency agrees with the ALJ that ``Respondent testified
clearly, candidly, and without hesitation,'' notwithstanding that he
``unarguably possesses . . . the greatest motivation to enhance,
modify, or even fabricate his testimony.'' RD, at 9. Respondent
``did not shy away from difficult questions and his answers
contained no caveats or attempts to minimize his behavior,'' and in
fact, the primary details regarding his fraudulent conduct came from
Respondent's testimony and exhibits. Id. at 9-10. Therefore, the
Agency agrees with the ALJ that Respondent's testimony should be
``afforded full credibility.'' Id. at 10.
---------------------------------------------------------------------------
Respondent's misconduct led to a series of arrests by local law
enforcement in 2015 and 2016, which resulted in charges for
prescription forgery. RD, at 6-7; Tr. 62-68. After the first arrest in
April of 2015, Respondent entered a residential treatment center for
three months, and has remained drug-free since. See supra III.B; RD, at
8; Tr. 93. While in recovery, local law enforcement referred his case
to Federal law enforcement and Federal charges were brought. RD, at 7;
Tr. 69-70. Respondent ultimately pled guilty and was federally
convicted in June of 2020. RD, at 7; Tr. 64, 70, 79.
B. Exclusion From Medicare
The Department of Health and Human Services (HHS) notified
Respondent by letter on October 29, 2021, that he would be ``exclud[ed]
from participation in all Federal health care programs . . . for a
minimum period of [seven] years.'' GX 3, at 1. The letter notified
Respondent that the exclusion was a result of Respondent's ``felony
conviction . . . related to the unlawful manufacture, distribution,
prescription, or dispensing of a controlled substance.'' Id. The letter
also notified Respondent that his period of exclusion exceeded the
minimum exclusion period of five years because his criminal sentence
included prison time, and because the Georgia Composite Medical Board
(Medical Board) had taken additional adverse action against Respondent
by suspending his medical license.\4\ Id. HHS considered these factors
to be ``aggravating circumstances.'' Id. The seven-year exclusion
period became effective on November 18, 2021. Id.
---------------------------------------------------------------------------
\4\ Respondent regained his state medical license in October of
2022. RD, at 6; Tr. 53.
---------------------------------------------------------------------------
II. Discussion
The Government alleged two independent grounds for denial: (1) that
Respondent has been convicted of a felony relating to controlled
substances, 21 U.S.C. 824(a)(2), 823(g)(1), and (2) that Respondent has
been excluded from participation in all Federal health care programs,
id. sections 824(a)(5), 823(g)(1). OSC, at 1-2. Having reviewed the
record and the RD, the Agency agrees with the ALJ, adopts the ALJ's
analysis, and finds that the Government has satisfied its prima facie
burden of demonstrating that both grounds for denial exist. Id. at 10-
12.
A. Felony Conviction
Pursuant to 21 U.S.C. 824(a)(2), the Attorney General is authorized
to suspend or revoke a registration issued under section 823 of the
Controlled Substances Act (CSA) ``upon a finding that the registrant .
. . has been convicted of a felony . . . relating to any . . .
controlled substance.'' 21 U.S.C. 824(a)(2). The Agency has
consistently held that it also may deny an application for a DEA
registration upon finding that the registrant has been convicted of a
felony relating to controlled substances. Arvinder Singh, M.D., 81 FR
8247, 8248 n.3 (2016) (quoting Kwan Bo Jin, M.D., 77 FR 35021, 35021
n.2 (2012)) (``[W]here a registration can be revoked under [21 U.S.C.]
824, it can, a fortiori, be denied under [21 U.S.C. ] 823 since the law
would not require an agency to indulge in the useless act of granting a
license on one day only to withdraw it on the next.''). Here, the
undisputed and substantial record evidence demonstrates that Respondent
has been convicted of a felony relating to controlled substances. OSC,
at 10-11. RD, at 11; GX 2; RX 1, at 3-4; Tr. 87-88.
B. Exclusion From Medicare
Respondent's application also may be denied ``upon a finding that
the registrant . . . has been excluded (or directed to be excluded)
from participation in a program pursuant to section 1320a-7(a) of Title
42.'' 21 U.S.C. 824(a)(5), 823(g)(1); Arvinder Singh, 81 FR 8248 n.3.
Here, the undisputed and substantial record evidence demonstrates that
HHS
[[Page 76154]]
mandatorily excluded Registrant from ``all Federal health care
programs'' under 42 U.S.C. 1320a-7(a)(4). RD, at 11; GX 3; ALJX 14, at
2; Tr. 30-31.
III. Sanction
Where, as here, the Government has established sufficient grounds
to deny a Respondent'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, 18904 (2018).
When a registrant has committed acts inconsistent with the public
interest, he 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). 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 33738, 33746 (2021).
A. Acceptance of Responsibility
Here, the Agency agrees with the ALJ that Respondent unequivocally
accepted responsibility for his conduct. RD, at 12-14. Respondent took
every opportunity to acknowledge that his conduct was wrong and he made
no efforts to minimize it. Id. at 13. He admitted that he was guilty of
dispensing controlled substances outside of his professional practice
because he forged prescriptions and fraudulently filled his patients'
prescriptions for his own use. RD, at 13; Tr. 84-85. Respondent
testified that he did not want to defend or glorify his conduct, and
stated that ``it is a shameful, morally bad place to be.'' RD, at 13;
Tr. 56, 84-86. He also acknowledged that he ``abused the public trust
as a physician.'' RD, at 13; Tr. 83. Respondent testified that he has
``been completely honest'' about his behavior and conduct ``with every
single person that [he has] spoken to whether it's law enforcement,
whether in the legal system, [or] in treatment.'' Tr. 89-90. Respondent
testified that the judge presiding over his criminal sentencing hearing
``spoke highly'' of him, and noted his acceptance of responsibility and
willingness to cooperate.\5\ RD, at 8; Tr. 80. Accordingly, the Agency
agrees with the ALJ that Respondent unequivocally accepted
responsibility for his misconduct,\6\ RD, at 12-14, and commends
Respondent for his willingness to candidly reflect on his battle with
addiction in a public forum.
---------------------------------------------------------------------------
\5\ Respondent's credible, unchallenged testimony regarding his
acceptance of responsibility in his criminal proceedings weighs in
his favor. See Michele L. Martinho, M.D., 86 FR 24012, 24020 n.*E
(2021) (citing Mohammed Asgar, 83 FR 29569, 29573 n.3 (2018)) (An
AUSA or Judge's comments regarding a respondent's acceptance of
responsibility during criminal proceedings are not binding on the
Agency, but they are relevant evidence).
\6\ The Government seems to acknowledge in its Post-hearing
Brief that Respondent accepted responsibility for his conduct. ALJX
23, at 25.
---------------------------------------------------------------------------
B. Remedial Measures
Having found that Respondent has unequivocally accepted
responsibility for his conduct, the Agency considers whether Respondent
has implemented sufficient remedial measures to demonstrate that he
will not engage in future misconduct and can be trusted with a
registration. Jayam Krishna-Iyer, M.D., 74 FR 459, 463 (2009). The
Agency has acknowledged that ``[i]n self-abuse cases, . . . successful
rehabilitation efforts are an important consideration in determining
whether a respondent can be trusted with a registration.'' Trenton F.
Horst, D.O., 80 FR 41079, 41091 (2015); see also Abbas E. Sina, M.D.,
80 FR 53191, 53201 (2015) (``[T]he risk of relapse becomes critical in
determining what steps are warranted when determining the public
interest.'').
Respondent provided extensive testimony regarding his recovery and
his efforts to remain sober. RD, at 15; Tr. 106-108, 109-110. After his
first arrest in April of 2015, he entered a residential treatment
center for three months. RD, at 8; Tr. 93. He went into treatment
partially because he knew he would not be able to regain his medical
license without receiving treatment. RD, at 8; Tr. 94-95. After
completing residential treatment, Respondent entered a ``Chemical
Addiction Monitoring Agreement'' with the Georgia Professional Health
Program (PHP). RD, at 8-9; RX 2, at 1. The agreement required him to
submit to random drug tests and attend self-help meetings, small-group
counseling sessions, and meetings with other physicians in the PHP. RD,
at 9; Tr. 96-97; RX 2, at 1-3. The initial agreement lasted for five
years, and he completed it before entering Federal prison in July of
2020. RD, at 9; Tr. 107-09; RX 2, at 1. Respondent was not monitored by
the PHP during his incarceration. RD, at 9; Tr. 108-109. Respondent
entered a second agreement with the PHP in September of 2022, which
required him to continue to attend various meetings and submit to
random drug tests. RD, at 9; Tr. 107-08; RX 2, at 9-17. Respondent
testified that he entered the new agreement because he wanted ``to do
whatever [the] Georgia PHP felt was needed for [him] to be a reliable
physician,'' but that he also had an ``overwhelming desire not to fall
back into addiction.'' RD, at 15; Tr. 106. Because Respondent does ``a
good bit'' more than is required by the Georgia PHP agreement, he was
recently transitioned to a ``senior monitoring agreement,'' which still
requires him to submit to random drug tests. RD, at 9, 15; Tr. 111-12.
Respondent testified that he plans to remain under the supervision
of the Georgia PHP even if he is no longer required to do so to
maintain his medical license. RD, at 15; Tr. 112. He also plans to
continue taking random drug tests, because even though there is ``no
part of [him] that wants to take a drug[,] . . . the statistics [are]
brutal on relapses,'' so he ``[cannot] imagine what would possess [him]
to not continue to be accountable to a urine drug test.'' RD, at 15-16;
Tr. 112. Respondent testified that drug testing is one of the best
tools to reduce the likelihood of remission. RD, at 16; Tr. 112.
Respondent testified that he has taken hundreds of drug tests, and that
there has only been one one-month period since April of 2015 that he
has not been subject to random drug tests. Tr. 97. Respondent testified
that he has never failed a drug test and that he has remained drug-free
since entering treatment in April of 2015. Id.
Perhaps the most concrete remedial measure that Respondent has
taken--which addresses both his addiction and the prescription
forgery--is that he applied for a registration to dispense drugs only
in Schedules III through V. Id. at 16; Tr. 37; 114-115; GX 4, at 1.
Respondent testified that he does not want authority to prescribe
Schedule II drugs because those are the drugs that he previously
abused. RD, at 16; Tr. 85-86, 114-115.
Respondent believes that he can be trusted with a registration
because of his understanding of addiction and his understanding of how
doctors can abuse their power to write prescriptions. RD, at 16; Tr.
119. According to Respondent, with this knowledge, he is safer writing
prescriptions than the majority of physicians. Id. Respondent requests
authority to prescribe controlled substances in Schedules III through V
so that he can work in an inpatient treatment facility that manages
medical detoxification and treats patients with ongoing chronic
illnesses, such as
[[Page 76155]]
diabetes or mental health issues. RD, at 6; Tr. 58, 124. Respondent
currently volunteers as a physician at a long-term recovery center
where he is not required to possess a DEA registration. RD, at 5; Tr.
57, 123.
Analysis of Respondent's remedial measures is particularly complex.
On one hand, the weight of the remedial evidence is reduced because the
measures were not implemented until after Respondent was arrested, and
many of these measures are mandatory under an agreement with the
Medical Board.\7\ RD, at 15; Tr. 107. On the other hand, Respondent has
made a sincere commitment to remaining drug-free for himself and for
his family, and has gone above and beyond the Medical Board's
requirements to ensure he does so. RD, at 15; Tr. 111. For example,
Respondent's application seeks only to handle drugs in Schedules III
through V to ensure that he does not have access to the Schedule II
drugs that he abused in the past. RD, at 16; Tr. 85-86, 114-115. With
these extensive remedial measures Respondent has remained sober for
approximately nine years. Accordingly, the ALJ found, and the Agency
agrees, that Respondent can be trusted with a DEA registration. RD, at
16.
---------------------------------------------------------------------------
\7\ The Agency has held that remedial measures are given
``limited-to-no-weight'' when they are implemented after enforcement
begins. See, e.g., Morris & Dickson Co., LLC, 88 FR 34523, 34539-40
(2023) (citing Mireille Lalanne, M.D., 78 FR 47750, 47777 (2013)
(``The Agency has recognized that a cessation of illegal behavior
only when `DEA comes knocking at one's door,' can be afforded a
diminished weight borne of its own opportunistic timing.'');
Southwood Pharmaceuticals, Inc., 72 FR 36487, 36503 (2007) (giving
no weight to respondent's ``stroke-of-midnight decision'' to cease
supplying suspect pharmacies with controlled substances and to
employ a compliance officer). This principle applies in even greater
force here, where the remedial measures that Respondent has
implemented appear to be mandatory under an agreement with the state
medical board, rather than voluntary.
---------------------------------------------------------------------------
C. Deterrent Effect and Egregiousness
Acceptance of responsibility and remedial measures are assessed in
the context of the ``egregiousness of the violations and the [DEA's]
interest in deterring similar misconduct by [the] Respondent in the
future as well as on the part of others.'' Daniel A. Glick, D.D.S., 80
FR 74800, 74810 (2015); OakmontScript Limited Partnership, 87 FR 21516,
21545 (2022). Because these administrative proceedings are intended to
be remedial, rather than punitive, the Agency has previously found
that, under appropriate circumstances, ``criminal convictions and
sanctions by state licensing authorities can sufficiently deter
physicians from engaging in misconduct, making the denial of an
application . . . unnecessary to achieve the goal of general
deterrence.'' Gilbert Y. Kim, D.D.S., 87 FR 21139, 21145 (2022) (citing
Kansky J. Delisma, M.D., 85 FR 23845, 23854 (2020)). The Agency has
also held that, sometimes, ``such punitive measures can suffice to
deter the registrant or applicant from future misconduct, making
revocation or denial of an application unnecessary to achieve specific
deterrence.'' Id.
Here, the Agency does not find that imposing a sanction is
necessary to deter Respondent from engaging in future misconduct.
Respondent has already faced significant legal consequences for his
misconduct, including multiple arrests, jailtime, supervised release,
and the loss of his state medical license and DEA registration.
Respondent has also undergone significant monitoring to recover and
maintain his state medical license, including taking hundreds of random
drug tests and attending frequent substance abuse meetings. RD, at 9;
Tr. 96-97; RX 2, at 1-3. Respondent testified that the consequences of
his unlawful behavior have hurt him and his family. Tr. 131. Thus, the
Agency finds that the punitive, remedial, and personal consequences
that Respondent has suffered are sufficient to deter him from engaging
in future misconduct, especially given Respondent's strong personal and
professional commitment to remaining drug-free. Respondent's commitment
to sobriety is a strong deterrent to future misconduct, as Respondent
testified that the only reason that he engaged in the fraudulent
conduct that led to the felony conviction and Medicare exclusion was to
feed his personal addiction. RD, at 6; Tr. 60. Respondent's decision
not to request authority to prescribe the Schedule II drugs that he
previously abused is also a significant deterrent. RD, at 16; Tr. 85-
86, 114-115. Moreover, there is no evidence that Respondent has
committed any additional CSA violations since entering treatment in
April of 2015, which bolsters the Agency's conclusion that Respondent
has been sufficiently deterred from future violations.
The Agency also finds that the significant consequences that
Respondent has faced are sufficient to deter the general registrant
community from committing similar misconduct of forging prescriptions
and diverting controlled substances for personal use. This Decision
should signal to the registrant community that CSA violations are
likely to result in serious legal consequences--as Respondent
confronted a protracted legal battle with local and Federal law
enforcement, state regulators, and DEA as a result of his misconduct.
But this Decision should also demonstrate to registrants recovering
from addiction that, by accepting responsibility, remediating their
actions, demonstrating sustained success with sobriety and conveying a
strong commitment to remaining sober, cooperating with state and
Federal enforcers, and demonstrating candor during enforcement
proceedings, they may be shown leniency.
Regarding egregiousness, there is no dispute that the conduct that
led to Respondent's conviction and subsequent exclusion from all
Federal health care programs was egregious.\8\ RD, at 17. Respondent
admitted to using extra samples at the hospital where he worked,
forging prescriptions using other physicians' DEA registrations, and
writing prescriptions with his own DEA registration purportedly for
home-bound patients. Id. Indeed, such cases of fraud and forgery are
particularly egregious because Respondent used his knowledge as a DEA
registrant to circumvent the closed system of distribution, and he
diverted powerful Schedule II controlled substances. Id. ``These are
actions that strike at the very heart of the responsibilities entrusted
to a DEA registrant . . . .'' Id. (citing Jana Marjenhoff, D.O., 80 FR
29067, 29095 (2015)).
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\8\ The Government argues in its Exceptions that ``the
egregiousness of Respondent's conduct supports denial and outweighs
any acceptance of responsibility or proposed remedial measures.''
Government's Exceptions, at 4. The Agency agrees with the Government
that Respondent's conduct was egregious, but finds that other
factors discussed throughout this Decision obviate the need for a
sanction in this case.
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However, the evidence overwhelmingly suggests that Respondent has
unequivocally accepted responsibility, is remorseful for his conduct,
has taken efforts to help others recover from addiction, and
rehabilitated himself even before he was convicted and required to
serve his time. He has also taken steps to reduce the likelihood of
recurrence by limiting his application to drugs in Schedules III
through V that he has never abused. In other words, Respondent has
presented convincing evidence to demonstrate that the Agency can trust
him with a registration.\9\ Therefore, the Agency will grant his
application.
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\9\ For all of the reasons set forth herein, the Agency finds
that it can fully trust Respondent with a registration. The Agency
therefore finds that the ALJ's recommended conditions on
Respondent's registration are unnecessary. RD, at 20-21. However,
the Agency's trust can be lost in the event of a relapse, so the
Agency encourages Respondent to stick to his plan to continue taking
random drug tests. As Respondent testified, ``the statistics [are]
brutal on relapses,'' and drug testing is one of the best tools to
reduce the likelihood of remission. RD, at 15-16; Tr. 112.
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[[Page 76156]]
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823 and 824, I hereby dismiss the Order to Show Cause issued to
George Gowder, III, M.D., and grant Respondent's application number
W22147308C in Schedules III through V. This Order is effective
immediately.
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 11, 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. 2024-21051 Filed 9-16-24; 8:45 am]
BILLING CODE 4410-09-P