George D. Gowder, III, M.D.; Decision and Order, 76152-76156 [2024-21051]

Download as PDF 76152 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices 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: ddrumheller on DSK120RN23PROD with NOTICES1 Controlled substance VerDate Sep<11>2014 17:12 Sep 16, 2024 Jkt 262001 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 PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 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 E:\FR\FM\17SEN1.SGM 17SEN1 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices 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 ddrumheller on DSK120RN23PROD with NOTICES1 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. VerDate Sep<11>2014 17:12 Sep 16, 2024 Jkt 262001 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 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 76153 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. E:\FR\FM\17SEN1.SGM 17SEN1 76154 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices 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. ddrumheller on DSK120RN23PROD with NOTICES1 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 VerDate Sep<11>2014 17:12 Sep 16, 2024 Jkt 262001 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. PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 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 E:\FR\FM\17SEN1.SGM 17SEN1 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices 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 ddrumheller on DSK120RN23PROD with NOTICES1 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. VerDate Sep<11>2014 17:12 Sep 16, 2024 Jkt 262001 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 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 76155 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]


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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)).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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
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