Isaac Sved, M.D.; Decision and Order, 75323-75326 [2023-24153]

Download as PDF Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices The Administrator further proposes that aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero. These proposed 2024 quotas reflect the quantities that DEA believes are necessary to meet the estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements; and the establishment and maintenance of reserve stocks. DEA remains committed to conducting continuous surveillance on the supply of schedule II controlled substances and list I chemicals necessary to treat patients with COVID– 19, and, pursuant to her authority, the Administrator will move swiftly and decisively to increase any 2024 APQ that she determines is necessary to address an unforeseen increase in demand, should that occur. In accordance with 21 CFR 1303.13 and 1315.13, upon consideration of the relevant factors, the Administrator may adjust the 2024 APQ and AAN as needed. Conclusion After consideration of any comments or objections, or after a hearing, if one is held, the Administrator will issue and publish in the Federal Register a final order establishing the 2024 APQ for controlled substances in schedules I and II and establishing an AAN for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, as directed by 21 CFR 1303.11(c) and 1315.11(f). khammond on DSKJM1Z7X2PROD with NOTICES Signing Authority This document of the Drug Enforcement Administration was signed on October 30, 2023, 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. Scott Brinks, Federal Register Liaison Officer, Drug Enforcement Administration. [FR Doc. 2023–24282 Filed 11–1–23; 8:45 am] BILLING CODE P VerDate Sep<11>2014 16:32 Nov 01, 2023 Jkt 262001 75323 Drug Enforcement Administration findings of fact, conclusions of law, sanctions analysis, and recommended sanction as found in the RD. [Docket No. 23–17] I. Findings of Fact Isaac Sved, M.D.; Decision and Order Georgia Standard of Care DEA hired Dr. Lobel to testify as an expert in the standard of care for the practice of medicine and the prescribing of controlled substances in the state of Georgia, with a focus on pain management. RD, at 4; Tr. 105.3 Dr. Lobel defined ‘‘standard of care’’ as a ‘‘minimum level of competence or care so as not to harm the patient,’’ and described how the Georgia standard of care requires a practitioner to, prior to prescribing controlled substances, obtain a patient’s prior medical records; obtain a medical history, including family medical history and mental health history; conduct an appropriate physical examination; obtain a urine drug screen; check the PDMP; obtain informed consent from the patient; and document all information. RD, at 11; Tr. 120, 128–129, 134, 136. Further, the physical examination must be appropriate to the complaint, and for patients who have spinal pain, the practitioner should also conduct a complete neurologic exam. RD, at 11; Tr. 129–130. In addition, the Georgia standard of care requires that a practitioner determine and document the severity of pain. RD, at 11; Tr. 135– 136. Dr. Lobel testified that under the Georgia standard of care, opioids ‘‘are not first-line treatment for chronic pain,’’ so a practitioner must ‘‘weigh the risks and benefits at every visit,’’ as well as look out for adverse effects, side effects, and aberrant behavior. RD, at 11; Tr. 132–133, 136–137. According to Dr. Lobel, under the Georgia standard of care, a practitioner should consider taking a patient off of opioids when there is a ‘‘lack of functional benefit, toxic effects of the medicine where they’re having end organ damage, . . . [or] someone [] showing any signs or symptoms of addiction,’’ and patients DEPARTMENT OF JUSTICE On December 8, 2022, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to Isaac Sved, M.D. (Respondent) of Buford, Georgia. OSC/ISO, at 1. The OSC/ISO informed Respondent of the immediate suspension of his DEA Certificate of Registration, Control No. BS4103610, pursuant to 21 U.S.C. 824(d), alleging that Respondent’s continued registration constitutes ‘‘ ‘an imminent danger to the public health or safety.’ ’’ Id. (quoting 21 U.S.C. 824(d)). The OSC/ISO also proposed the revocation of Respondent’s registration, alleging that Respondent has ‘‘committed such acts as would render [his] registration inconsistent with the public interest.’’ Id. at 1, 4 (citing 21 U.S.C. 823(g)(1),1 824(a)(4)). A hearing was held before DEA Administrative Law Judge Teresa A. Wallbaum (the ALJ) who, on June 20, 2023, issued her Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision (Recommended Decision or RD), which recommended revocation of Respondent’s registration. RD, at 27. Respondent did not file 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 1 Effective December 2, 2022, the Medical Marijuana and Cannabidiol Research Expansion Act, Public Law 117–215, 136 Stat. 2257 (2022) (Marijuana Research Amendments or MRA), amended the Controlled Substances Act (CSA) and other statutes. Relevant to this matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC/ISO, as 21 U.S.C. 823(g)(1). Accordingly, this Decision cites to the current designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA throughout. 2 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 3–17. The Agency agrees with the ALJ that the Diversion Investigator’s testimony, which was focused on the uncontroversial introduction of documentary evidence and her contact with the case, was credible in that it was sufficiently detailed, plausible, and internally consistent. Id. at 4. Further, the Agency agrees with the ALJ that the testimony from the Government’s expert witness, Dr. Steven Lobel, M.D., which was focused on the Georgia standard of care and Respondent’s prescribing to the patients listed in the OSC/ISO, was credible in that it was consistent with Georgia statutes governing the prescribing of controlled substances, especially in the pain management context, and was clear, direct, substantial, and consistent with regards to the individual patients. Id. at 4–5. Finally, the Agency agrees with the ALJ that although Respondent’s testimony was credible as to general facts, including Respondent PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 volunteering information regarding prior disciplinary actions, on the issue of whether his prescriptions were within the usual course of professional practice and for a legitimate medical purpose, Respondent’s testimony was not fully credible in that his interpretations of the Georgia standard of care were inconsistent with the Georgia state statutes. Id. at 9–10. 3 During the hearing, both Government counsel and Dr. Lobel initially referenced a national standard of care established by the CDC Guidelines, see RD, at 10, but Dr. Lobel ultimately testified that the Georgia standard of care, upon which this decision is based, is grounded in the state medical board’s publications and Georgia state statutes, with the CDC Guidelines incorporated to the extent that they deal with the prescriptions of opioids. RD, at 10; Tr. 114–115, 119, 125. E:\FR\FM\02NON1.SGM 02NON1 75324 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices should be tapered off of opioids if they are not in pain or if they are abusing the opioid prescription. RD, at 11–12; Tr. 140, 146–147. Regarding the relevant red flags of abuse and diversion, Dr. Lobel testified that under the Georgia standard of care, there is never a legitimate medical purpose for prescribing the ‘‘Holy Trinity’’ because ‘‘[e]ach medicine synergistically affects the other to augment a high’’ and it produces ‘‘respiratory drive’’ as a side effect. RD, at 12; Tr. 148–149, 173. Moreover, Dr. Lobel testified that duplicative therapies, that is, prescriptions for the same drugs in different strengths at high quantities, are not legitimate medical practice and fall out of the standard of care, with Dr. Lobel differentiating between prescribing ‘‘two dose units of the same medication to get a higher dose unit at high quantities’’ and prescribing a separate daytime and nighttime pain medicine. RD, at 12; Tr. 109, 149–151.4 khammond on DSKJM1Z7X2PROD with NOTICES Respondent In 2010, Respondent began a family medicine and pain management practice in Atlanta.5 RD, at 5; Tr. 335–336, 347, 363, 372. Respondent testified that most of his patients are ‘‘hard-working bluecollar workers’’ and ‘‘laborers’’ and that his patients prefer short-acting opioids because they do not make them as drowsy as long-acting opioids, therefore allowing the patients to control their pain but still be able to work. RD, at 6; Tr. 343–345, 376–377. Respondent testified that his patients also worry about ‘‘cost-effectiveness’’ because ‘‘they don’t have great insurance . . . [and] they can’t really afford to do physical therapy.’’ RD, at 7; Tr. 348. Respondent testified that he has seen many of his pain patients since 2010 or 2012 and that he started these patients on lower doses of opioids that increased over time with changes in drugs and dosages. RD, at 7; Tr. 345. Respondent testified that he ‘‘do[es] the rational thoughts as to why [he] prescribe[s] these medications. [He] do[es not] willynilly prescribe 120 doses of anything without thinking it through.’’ RD, at 7; Tr. 345–346. According to Respondent, 4 Dr. Lobel testified that although Georgia law does not specifically prohibit prescribing the ‘‘Holy Trinity’’ or duplicative therapies, the standard of care described comes from the state medical board. RD, at 12 n.10; Tr. 173, 290. 5 Respondent testified that although he is not board-certified in pain management, he has completed many hours of training. RD, at 5; Tr. 372. Specifically, he ‘‘took specialized courses offered by . . . the American Academy of Pain Management.’’ RD, at 5; Tr. 347. Respondent is also a member of the American Academy of Pain Physicians, Integrative Pain Management, and performs immigration physicals. RD, at 6; Tr. 347, 363. VerDate Sep<11>2014 16:32 Nov 01, 2023 Jkt 262001 he is ‘‘kind of old school’’ and ‘‘spend[s] more time talking to [patients], examining them, and counseling them than writing notes.’’ RD, at 7; Tr. 346. Regarding opioids, Respondent acknowledged that an opioid prescription must be medically necessary. RD, at 7; Tr. 378. Respondent testified that he does ‘‘everything [he is] supposed to do as far as the Georgia requirements for pain management,’’ but that he does not ‘‘always write them down because . . . most of [his] practice is to take care of the patients and not write paper.’’ RD, at 8; Tr. 350, see also Tr. 375, 376. Respondent also testified that although he sometimes ‘‘missed’’ information in his notes, all of the patient information is documented in patient files in an ‘‘abbreviated form.’’ RD, at 8; Tr. 375–376. Regarding the prescription of the ‘‘Holy Trinity,’’ Respondent acknowledged that it is a dangerous combination, but testified that ‘‘if [patients] failed other muscle relaxants, I usually have to go to . . . the one that seems to work the best.’’ RD, at 8; Tr. 351, 353. Respondent asserted that he discusses the risk of combination prescriptions with patients. RD, at 8; 355–356. Respondent testified that he uses an application on his phone called Medscape to check for interactions between medications. RD, at 9; Tr. 354– 355.6 Ultimately, Respondent testified that his job is ‘‘to make people feel healthy and good.’’ RD, at 9; Tr. 360. Respondent testified that he is familiar with and adheres to the Georgia standard of care, as found in the laws published by the Georgia medical board website. RD, at 9; Tr. 338, 365–369. Regarding the patients listed in the OSC/ISO, Respondent testified that his patients were ‘‘fully informed as to the nature of [his] proposals’’ and that his prescriptions were within the standard of care, with his patients receiving ‘‘more medical benefit than risk.’’ RD, at 9; 365–366. Respondent also denied running a ‘‘pill mill’’ or having any arrangement with his patients regarding selling the controlled substance prescriptions and denied knowingly or directly profiting from any diversion, and according to Respondent, none of his patients have been arrested for diversion. RD, at 9; Tr. 342, 364–365. 6 Regarding the combination of oxycodone, Soma, and Xanax, the ‘‘Holy Trinity’’, Respondent testified that the Medscape application reports three interactions of those drugs and says to ‘‘monitor closely’’ but does not say ‘‘severe adverse reaction.’’ RD, at 9; Tr. 355. PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 The Patients Patient J.W. On at least three occasions, Respondent issued prescriptions to Patient J.W. that in combination formed the ‘‘Holy Trinity.’’ Specifically, on May 15, 2022, June 12, 2022, and July 17, 2022, Respondent prescribed 30 mg oxycodone, 2 mg alprazolam, and 350 mg carisoprodol. RD, at 13; Tr. 109, 274, 277, 280; GX 2, at 14–15, 17–18, 20–21. On each date, Respondent also prescribed a second opioid, Percocet, a brand name for oxycodone/ acetaminophen, a schedule II opioid. RD, at 13; Tr. 274, 277, 280; GX 2, at 14, 17, 20. Because there was no documentation justifying prescribing the ‘‘Holy Trinity,’’ Dr. Lobel concluded, and the Agency agrees, that the prescriptions were not issued within the Georgia standard of care. RD, at 13; Tr. 275, 277, 280–282; GX 2, at 16, 19, 22. Accordingly, the ALJ found, and the Agency agrees, that the prescriptions were not issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. RD, at 13. Patient S.D. On at least three occasions, Respondent issued prescriptions to Patient S.D. that in combination formed the ‘‘Holy Trinity.’’ Specifically, on April 27, 2022, May 25, 2022, and June 22, 2022, Respondent prescribed 30 mg oxycodone, 2 mg alprazolam, and 350 mg carisoprodol. RD, at 13–14; Tr. 265, 268–269, 270; GX 3, at 213, 217, 219. Moreover, on each date, Respondent also prescribed Percocet and Valium, a brand name for diazepam, a schedule IV benzodiazepine, forming a ‘‘double’’ ‘‘Holy Trinity’’ because there were two opioids and two benzodiazepines in combination with the carisoprodol. RD, at 14; Tr. 265, 268–270, 272; GX 3, at 213, 217, 219. Because there was no documentation justifying the prescriptions, Dr. Lobel concluded, and the Agency agrees, that the prescriptions were not issued within the Georgia standard of care. RD, at 14; Tr. 266, 267, 269, 271. Accordingly, the ALJ found, and the Agency agrees, that the prescriptions were not issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. RD, at 14. Patient T.J. On at least three occasions, Respondent issued prescriptions to Patient T.J. that in combination formed the ‘‘Holy Trinity.’’ Specifically, on May 9, 2022, June 6, 2022, and June 30, 2022, Respondent prescribed 30 mg E:\FR\FM\02NON1.SGM 02NON1 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices oxycodone, 2 mg alprazolam, and 350 mg carisoprodol. RD, at 14–15; Tr. 259, 261, 263; GX 4, at 190, 192, 195. Because there was no documentation justifying prescribing the ‘‘Holy Trinity,’’ Dr. Lobel concluded, and the Agency agrees, that the prescriptions were not issued within the Georgia standard of care. RD, at 15; Tr. 260, 262, 264.7 Accordingly, the ALJ found, and the Agency agrees, that the prescriptions were not issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. RD, at 15. khammond on DSKJM1Z7X2PROD with NOTICES Patient A.A. On at least three occasions, Respondent issued prescriptions to Patient A.A. that were therapeutically duplicative. Specifically, on April 11, 2022, June 6, 2022, and July 6, 2022, Respondent prescribed 30 mg oxycodone and Percocet. RD, at 15; Tr. 245, 250–251, 255; GX 5, at 63, 64, 66. As Dr. Lobel testified, oxycodone and Percocet are both immediate release opioids and so prescribing them in combination is therapeutic duplication. RD, at 15; Tr. 245–246, 250–251, 257. Because there was no documentation justifying the therapeutic duplication, Dr. Lobel concluded, and the Agency agrees, that the prescriptions were not issued within the Georgia standard of care. RD, at 15; Tr. 246, 249, 251, 253, 256–258; GX 5, at 37, 38, 40. Accordingly, the ALJ found, and the Agency agrees, that the prescriptions were not issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. RD, at 15–16. Patient L.B. On at least three occasions, Respondent issued prescriptions to Patient L.B. that were therapeutically duplicative. Specifically, on May 15, 2022, June 12, 2022, and July 10, 2022, Respondent prescribed 30 mg oxycodone and Percocet. RD, at 16; Tr. 221, 235, 238–239, 241–242; GX 6, at 35, 37, 39. Because there was no documentation justifying the therapeutic duplication, Dr. Lobel concluded, and the Agency agrees, that the prescriptions were not issued within the Georgia standard of care. RD, at 16; Tr. 236, 239 241; GX 5, at 36, 38, 40. Accordingly, the ALJ found, and the Agency agrees, that the prescriptions were not issued for a legitimate medical 7 Dr. Lobel testified that the documentation for the June 30, 2022, prescriptions did not support prescribing the ‘‘Holy Trinity,’’ but the Government did not elicit any testimony regarding the adequacy of the documentation for the other two dates for Patient T.J. RD, at 15 n.15; Tr. 263. VerDate Sep<11>2014 16:32 Nov 01, 2023 Jkt 262001 purpose by a practitioner acting in the usual course of professional practice. RD, at 16. Patient A.T. On at least three occasions, Respondent issued prescriptions to Patient A.T. that were therapeutically duplicative. Specifically, on April 6, 2022, May 4, 2022, and June 2, 2022, Respondent prescribed 30 mg oxycodone and Percocet. RD, at 16; Tr. 220–221, 225, 226, 228–229; GX 7, at 86, 87, 88. Because there was no documentation justifying the therapeutic duplication, Dr. Lobel concluded, and the Agency agrees, that the prescriptions were not issued within the Georgia standard of care. RD, at 16– 17; Tr. 221–222, 226–227, 231; GX 7, at 31–33. Accordingly, the ALJ found, and the Agency agrees, that the prescriptions were not issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. RD, at 17. I. Discussion A. The Five Public Interest Factors Under the CSA, ‘‘[a] registration . . . to . . . dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section.’’ 21 U.S.C. 824(a). In making the public interest determination, the CSA requires consideration of the following factors: (A) The recommendation of the appropriate State licensing board or professional disciplinary authority. (B) The [registrant’s] experience in dispensing, or conducting research with respect to controlled substances. (C) The [registrant’s] conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. (D) Compliance with applicable State, Federal, or local laws relating to controlled substances. (E) Such other conduct which may threaten the public health and safety. 21 U.S.C. 823(g)(1). DEA considers these public interest factors in the disjunctive. Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor is weighed on a case-by-case basis. Morall v. Drug Enf’t Admin., 412 F.3d 165, 173–74 (D.C. Cir. 2005). Any one factor, or combination of factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508 (1993). PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 75325 The Government has the burden of proof in this proceeding. 21 CFR 1301.44. While the Agency has considered all of the public interest factors in 21 U.S.C. 823(g)(1), the Government’s evidence in support of its prima facie case for revocation of Respondent’s registration is confined to Factors B and D. RD, at 18; see also RD, at 18 n.20 (finding that Factors A, C, and E do not weigh for or against revocation). Having reviewed the record and the RD, the Agency agrees with the ALJ, adopts the ALJ’s analysis, and finds that the Government’s evidence satisfies its prima facie burden of showing that Respondent’s continued registration would be ‘‘inconsistent with the public interest.’’ 21 U.S.C. 824(a)(4). RD, at 17– 23. B. Factors B and D Evidence is considered under Public Interest Factors B and D when it reflects compliance (or non-compliance) with laws related to controlled substances and experience dispensing controlled substances. See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D., 87 FR 21156, 21162 (2022). DEA regulations require that for a prescription for a controlled substance to be effective, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. 21 CFR 1306.04(a); see also 21 U.S.C. 829. Georgia state law too provides that a practitioner may only issue prescriptions while acting in the usual course of his professional practice and for a legitimate medical purpose. Ga. Code Ann. section 16–13–41(f)(2), (3). In the current matter, the Agency agrees with the ALJ’s analysis that Respondent’s treatment of the six patients described above fell below the Georgia standard of care and thus violated Federal and State law because, as detailed above, Respondent continually prescribed the ‘‘Holy Trinity’’ and duplicative therapies while failing to establish a medical justification for the prescriptions; as such, Respondent’s prescribing was not within the usual course of professional practice and not for a legitimate medical purpose.8 RD, at 20–21. As 8 The Agency also agrees with the ALJ’s conclusion that none of Respondent’s arguments— including, among others, that the case was initially based on unfounded criminal allegations; that the patients suffered no injuries as a result of Respondent’s treatment; that the Government’s case was only an attack on Respondent’s recordkeeping; that both public and private insurance companies saw fit to cover Respondent’s treatments; and that E:\FR\FM\02NON1.SGM Continued 02NON1 75326 Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices Respondent’s conduct displays clear violations of the Federal and State regulations described above, the Agency agrees with the ALJ and hereby finds that Respondent violated 21 U.S.C. 829; 21 CFR 1306.04(a); and Ga. Code Ann. section 16–13–41(f)(2), (3). Id. Accordingly, the Agency agrees with the ALJ and finds that Factors B and D weigh in favor of revocation of Respondent’s registration and thus finds Respondent’s continued registration to be inconsistent with the public interest in balancing the factors of 21 U.S.C. 823(g)(1). Id. at 23. khammond on DSKJM1Z7X2PROD with NOTICES III. Sanction Where, as here, the Government has established sufficient grounds to revoke Respondent’s registration, the burden shifts to the registrant to show why he can be entrusted with the responsibility carried by a registration. Garret Howard Smith, M.D., 83 FR 18882, 18910 (2018). 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) (internal quotations omitted). 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,9 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). Here, the Agency agrees with the ALJ that ‘‘Respondent’s hearing testimony and post-hearing arguments constitute a blanket denial of any wrongdoing.’’ RD, at 25. Notably, Respondent testified that he did ‘‘everything [he is] supposed to do as far as the Georgia requirements for pain management’’ and that ‘‘[t]his hobgoblin of a drug problem exists primarily in the mind of an easily excitable DEA.’’ Id. at 24–25; Tr. 350; Respondent’s Post-Hearing Brief, at 6. As stated by the ALJ, ‘‘Respondent’s testimony and argument simply cannot none of Respondent’s patients engaged in illicit activity—refute this analysis. RD, at 21–23. 9 The record shows that in 2006, Respondent entered into a Memorandum of Understanding (MOU) with DEA in which Respondent admitted to prescribing controlled substances arguably in violation of generally accepted standard practices and Federal regulations; prescribing a large number of narcotics, with over half of his 1,500 patients prescribed narcotics; and keeping samples of controlled substances at an unregistered location. RD, at 3; Tr. 24; GX 12. VerDate Sep<11>2014 16:32 Nov 01, 2023 Jkt 262001 be reconciled with the record evidence.’’ RD, at 25. As such, and because Respondent made no admittance of any wrongdoing on his part, the Agency agrees with the ALJ and finds that Respondent failed to unequivocally accept responsibility. Id. When a registrant fails to make the threshold showing of acceptance of responsibility, the Agency need not address the registrant’s remedial measures. Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019) (citing Jones Total Health Care Pharmacy, L.L.C. & SND Health Care, L.L.C., 81 FR 79188, 79202–03 (2016)); Daniel A. Glick, D.D.S., 80 FR 74800, 74801, 74810 (2015). Even so, in the current matter, Respondent did not present any evidence of remedial measures, and the Agency thus agrees with the ALJ that ‘‘[Respondent’s] failure to put forth any evidence of steps he has taken to avoid similar misconduct in the future shows that he cannot be entrusted with a [registration].’’ RD, at 26. In addition to acceptance of responsibility, the Agency considers both specific and general deterrence when determining an appropriate sanction. Daniel A. Glick, D.D.S., 80 FR at 74810. In this case, the Agency agrees with the ALJ that ‘‘failing to impose a significant sanction against Respondent would send the wrong message to registrants that the Agency does not take seriously a registrant who repeatedly prescribes dangerous drug cocktails and combinations.’’ RD, at 26. Regarding Respondent in particular, ‘‘[g]iven Respondent’s cavalier attitude regarding the standard of care, specific deterrence is necessary.’’ Id. Moreover, the Agency agrees with the ALJ that Respondent’s actions were egregious because Respondent not only ignored his obligations to issue prescriptions within the standard of care and instead prescribed combinations that he knew to be dangerous to his patients, but he also endangered the community at large given the risk of diversion when prescribing such combinations. Id. In sum, Respondent has not offered any credible evidence on the record to rebut the Government’s case for revocation of his registration and Respondent has not demonstrated that he can be entrusted with the responsibility of registration. RD, at 27. Accordingly, the Agency will order that Respondent’s registration be revoked. Order Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. BS4103610 issued to Isaac Sved, M.D. Further, pursuant to 28 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I hereby deny any pending applications of Isaac Sved, M.D., to renew or modify this registration, as well as any other pending application of Isaac Sved, M.D., for additional registration in Georgia. This Order is effective December 4, 2023. Signing Authority This document of the Drug Enforcement Administration was signed on October 25, 2023, 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. 2023–24153 Filed 11–1–23; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Blue Mint Pharmacy; Decision and Order On July 26, 2022, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to Blue Mint Pharmacy (Registrant) of Houston, Texas. Request for Final Agency Action (RFAA), Government Exhibit (RFAAX) 2, at 1. The OSC/ISO informed Registrant of the immediate suspension of its DEA Certificate of Registration (registration), Control No. FB4121327, pursuant to 21 U.S.C. 824(d), alleging that Registrant’s continued registration constitutes ‘‘‘an imminent danger to the public health or safety.’’’ Id. The OSC/ ISO also proposed the revocation of Registrant’s registration, alleging that Registrant’s continued registration is inconsistent with the public interest. Id. (citing 21 U.S.C. 824(a)(4), 823(g)(1)) 1. 1 Effective December 2, 2022, the Medical Marijuana and Cannabidiol Research Expansion Act, Public Law 117–215, 136 Stat. 2257 (2022) (Marijuana Research Amendments or MRA), amended the Controlled Substances Act (CSA) and other statutes. Relevant to this matter, the MRA E:\FR\FM\02NON1.SGM 02NON1

Agencies

[Federal Register Volume 88, Number 211 (Thursday, November 2, 2023)]
[Notices]
[Pages 75323-75326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24153]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 23-17]


Isaac Sved, M.D.; Decision and Order

    On December 8, 2022, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause and Immediate Suspension of 
Registration (OSC/ISO) to Isaac Sved, M.D. (Respondent) of Buford, 
Georgia. OSC/ISO, at 1. The OSC/ISO informed Respondent of the 
immediate suspension of his DEA Certificate of Registration, Control 
No. BS4103610, pursuant to 21 U.S.C. 824(d), alleging that Respondent's 
continued registration constitutes `` `an imminent danger to the public 
health or safety.' '' Id. (quoting 21 U.S.C. 824(d)). The OSC/ISO also 
proposed the revocation of Respondent's registration, alleging that 
Respondent has ``committed such acts as would render [his] registration 
inconsistent with the public interest.'' Id. at 1, 4 (citing 21 U.S.C. 
823(g)(1),\1\ 824(a)(4)).
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    \1\ Effective December 2, 2022, the Medical Marijuana and 
Cannabidiol Research Expansion Act, Public Law 117-215, 136 Stat. 
2257 (2022) (Marijuana Research Amendments or MRA), amended the 
Controlled Substances Act (CSA) and other statutes. Relevant to this 
matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC/ISO, 
as 21 U.S.C. 823(g)(1). Accordingly, this Decision cites to the 
current designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA 
throughout.
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    A hearing was held before DEA Administrative Law Judge Teresa A. 
Wallbaum (the ALJ) who, on June 20, 2023, issued her Recommended 
Rulings, Findings of Fact, Conclusions of Law, and Decision 
(Recommended Decision or RD), which recommended revocation of 
Respondent's registration. RD, at 27. Respondent did not file 
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, conclusions of law, 
sanctions analysis, and recommended sanction as found in the RD.
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    \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 3-17. The Agency agrees with 
the ALJ that the Diversion Investigator's testimony, which was 
focused on the uncontroversial introduction of documentary evidence 
and her contact with the case, was credible in that it was 
sufficiently detailed, plausible, and internally consistent. Id. at 
4. Further, the Agency agrees with the ALJ that the testimony from 
the Government's expert witness, Dr. Steven Lobel, M.D., which was 
focused on the Georgia standard of care and Respondent's prescribing 
to the patients listed in the OSC/ISO, was credible in that it was 
consistent with Georgia statutes governing the prescribing of 
controlled substances, especially in the pain management context, 
and was clear, direct, substantial, and consistent with regards to 
the individual patients. Id. at 4-5. Finally, the Agency agrees with 
the ALJ that although Respondent's testimony was credible as to 
general facts, including Respondent volunteering information 
regarding prior disciplinary actions, on the issue of whether his 
prescriptions were within the usual course of professional practice 
and for a legitimate medical purpose, Respondent's testimony was not 
fully credible in that his interpretations of the Georgia standard 
of care were inconsistent with the Georgia state statutes. Id. at 9-
10.
---------------------------------------------------------------------------

I. Findings of Fact

Georgia Standard of Care

    DEA hired Dr. Lobel to testify as an expert in the standard of care 
for the practice of medicine and the prescribing of controlled 
substances in the state of Georgia, with a focus on pain management. 
RD, at 4; Tr. 105.\3\ Dr. Lobel defined ``standard of care'' as a 
``minimum level of competence or care so as not to harm the patient,'' 
and described how the Georgia standard of care requires a practitioner 
to, prior to prescribing controlled substances, obtain a patient's 
prior medical records; obtain a medical history, including family 
medical history and mental health history; conduct an appropriate 
physical examination; obtain a urine drug screen; check the PDMP; 
obtain informed consent from the patient; and document all information. 
RD, at 11; Tr. 120, 128-129, 134, 136. Further, the physical 
examination must be appropriate to the complaint, and for patients who 
have spinal pain, the practitioner should also conduct a complete 
neurologic exam. RD, at 11; Tr. 129-130. In addition, the Georgia 
standard of care requires that a practitioner determine and document 
the severity of pain. RD, at 11; Tr. 135-136.
---------------------------------------------------------------------------

    \3\ During the hearing, both Government counsel and Dr. Lobel 
initially referenced a national standard of care established by the 
CDC Guidelines, see RD, at 10, but Dr. Lobel ultimately testified 
that the Georgia standard of care, upon which this decision is 
based, is grounded in the state medical board's publications and 
Georgia state statutes, with the CDC Guidelines incorporated to the 
extent that they deal with the prescriptions of opioids. RD, at 10; 
Tr. 114-115, 119, 125.
---------------------------------------------------------------------------

    Dr. Lobel testified that under the Georgia standard of care, 
opioids ``are not first-line treatment for chronic pain,'' so a 
practitioner must ``weigh the risks and benefits at every visit,'' as 
well as look out for adverse effects, side effects, and aberrant 
behavior. RD, at 11; Tr. 132-133, 136-137. According to Dr. Lobel, 
under the Georgia standard of care, a practitioner should consider 
taking a patient off of opioids when there is a ``lack of functional 
benefit, toxic effects of the medicine where they're having end organ 
damage, . . . [or] someone [] showing any signs or symptoms of 
addiction,'' and patients

[[Page 75324]]

should be tapered off of opioids if they are not in pain or if they are 
abusing the opioid prescription. RD, at 11-12; Tr. 140, 146-147. 
Regarding the relevant red flags of abuse and diversion, Dr. Lobel 
testified that under the Georgia standard of care, there is never a 
legitimate medical purpose for prescribing the ``Holy Trinity'' because 
``[e]ach medicine synergistically affects the other to augment a high'' 
and it produces ``respiratory drive'' as a side effect. RD, at 12; Tr. 
148-149, 173. Moreover, Dr. Lobel testified that duplicative therapies, 
that is, prescriptions for the same drugs in different strengths at 
high quantities, are not legitimate medical practice and fall out of 
the standard of care, with Dr. Lobel differentiating between 
prescribing ``two dose units of the same medication to get a higher 
dose unit at high quantities'' and prescribing a separate daytime and 
nighttime pain medicine. RD, at 12; Tr. 109, 149-151.\4\
---------------------------------------------------------------------------

    \4\ Dr. Lobel testified that although Georgia law does not 
specifically prohibit prescribing the ``Holy Trinity'' or 
duplicative therapies, the standard of care described comes from the 
state medical board. RD, at 12 n.10; Tr. 173, 290.
---------------------------------------------------------------------------

Respondent

    In 2010, Respondent began a family medicine and pain management 
practice in Atlanta.\5\ RD, at 5; Tr. 335-336, 347, 363, 372. 
Respondent testified that most of his patients are ``hard-working blue-
collar workers'' and ``laborers'' and that his patients prefer short-
acting opioids because they do not make them as drowsy as long-acting 
opioids, therefore allowing the patients to control their pain but 
still be able to work. RD, at 6; Tr. 343-345, 376-377. Respondent 
testified that his patients also worry about ``cost-effectiveness'' 
because ``they don't have great insurance . . . [and] they can't really 
afford to do physical therapy.'' RD, at 7; Tr. 348.
---------------------------------------------------------------------------

    \5\ Respondent testified that although he is not board-certified 
in pain management, he has completed many hours of training. RD, at 
5; Tr. 372. Specifically, he ``took specialized courses offered by . 
. . the American Academy of Pain Management.'' RD, at 5; Tr. 347. 
Respondent is also a member of the American Academy of Pain 
Physicians, Integrative Pain Management, and performs immigration 
physicals. RD, at 6; Tr. 347, 363.
---------------------------------------------------------------------------

    Respondent testified that he has seen many of his pain patients 
since 2010 or 2012 and that he started these patients on lower doses of 
opioids that increased over time with changes in drugs and dosages. RD, 
at 7; Tr. 345. Respondent testified that he ``do[es] the rational 
thoughts as to why [he] prescribe[s] these medications. [He] do[es not] 
willy-nilly prescribe 120 doses of anything without thinking it 
through.'' RD, at 7; Tr. 345-346. According to Respondent, he is ``kind 
of old school'' and ``spend[s] more time talking to [patients], 
examining them, and counseling them than writing notes.'' RD, at 7; Tr. 
346.
    Regarding opioids, Respondent acknowledged that an opioid 
prescription must be medically necessary. RD, at 7; Tr. 378. Respondent 
testified that he does ``everything [he is] supposed to do as far as 
the Georgia requirements for pain management,'' but that he does not 
``always write them down because . . . most of [his] practice is to 
take care of the patients and not write paper.'' RD, at 8; Tr. 350, see 
also Tr. 375, 376. Respondent also testified that although he sometimes 
``missed'' information in his notes, all of the patient information is 
documented in patient files in an ``abbreviated form.'' RD, at 8; Tr. 
375-376.
    Regarding the prescription of the ``Holy Trinity,'' Respondent 
acknowledged that it is a dangerous combination, but testified that 
``if [patients] failed other muscle relaxants, I usually have to go to 
. . . the one that seems to work the best.'' RD, at 8; Tr. 351, 353. 
Respondent asserted that he discusses the risk of combination 
prescriptions with patients. RD, at 8; 355-356. Respondent testified 
that he uses an application on his phone called Medscape to check for 
interactions between medications. RD, at 9; Tr. 354-355.\6\ Ultimately, 
Respondent testified that his job is ``to make people feel healthy and 
good.'' RD, at 9; Tr. 360.
---------------------------------------------------------------------------

    \6\ Regarding the combination of oxycodone, Soma, and Xanax, the 
``Holy Trinity'', Respondent testified that the Medscape application 
reports three interactions of those drugs and says to ``monitor 
closely'' but does not say ``severe adverse reaction.'' RD, at 9; 
Tr. 355.
---------------------------------------------------------------------------

    Respondent testified that he is familiar with and adheres to the 
Georgia standard of care, as found in the laws published by the Georgia 
medical board website. RD, at 9; Tr. 338, 365-369. Regarding the 
patients listed in the OSC/ISO, Respondent testified that his patients 
were ``fully informed as to the nature of [his] proposals'' and that 
his prescriptions were within the standard of care, with his patients 
receiving ``more medical benefit than risk.'' RD, at 9; 365-366. 
Respondent also denied running a ``pill mill'' or having any 
arrangement with his patients regarding selling the controlled 
substance prescriptions and denied knowingly or directly profiting from 
any diversion, and according to Respondent, none of his patients have 
been arrested for diversion. RD, at 9; Tr. 342, 364-365.

The Patients

Patient J.W.
    On at least three occasions, Respondent issued prescriptions to 
Patient J.W. that in combination formed the ``Holy Trinity.'' 
Specifically, on May 15, 2022, June 12, 2022, and July 17, 2022, 
Respondent prescribed 30 mg oxycodone, 2 mg alprazolam, and 350 mg 
carisoprodol. RD, at 13; Tr. 109, 274, 277, 280; GX 2, at 14-15, 17-18, 
20-21. On each date, Respondent also prescribed a second opioid, 
Percocet, a brand name for oxycodone/acetaminophen, a schedule II 
opioid. RD, at 13; Tr. 274, 277, 280; GX 2, at 14, 17, 20. Because 
there was no documentation justifying prescribing the ``Holy Trinity,'' 
Dr. Lobel concluded, and the Agency agrees, that the prescriptions were 
not issued within the Georgia standard of care. RD, at 13; Tr. 275, 
277, 280-282; GX 2, at 16, 19, 22. Accordingly, the ALJ found, and the 
Agency agrees, that the prescriptions were not issued for a legitimate 
medical purpose by a practitioner acting in the usual course of 
professional practice. RD, at 13.
Patient S.D.
    On at least three occasions, Respondent issued prescriptions to 
Patient S.D. that in combination formed the ``Holy Trinity.'' 
Specifically, on April 27, 2022, May 25, 2022, and June 22, 2022, 
Respondent prescribed 30 mg oxycodone, 2 mg alprazolam, and 350 mg 
carisoprodol. RD, at 13-14; Tr. 265, 268-269, 270; GX 3, at 213, 217, 
219. Moreover, on each date, Respondent also prescribed Percocet and 
Valium, a brand name for diazepam, a schedule IV benzodiazepine, 
forming a ``double'' ``Holy Trinity'' because there were two opioids 
and two benzodiazepines in combination with the carisoprodol. RD, at 
14; Tr. 265, 268-270, 272; GX 3, at 213, 217, 219. Because there was no 
documentation justifying the prescriptions, Dr. Lobel concluded, and 
the Agency agrees, that the prescriptions were not issued within the 
Georgia standard of care. RD, at 14; Tr. 266, 267, 269, 271. 
Accordingly, the ALJ found, and the Agency agrees, that the 
prescriptions were not issued for a legitimate medical purpose by a 
practitioner acting in the usual course of professional practice. RD, 
at 14.
Patient T.J.
    On at least three occasions, Respondent issued prescriptions to 
Patient T.J. that in combination formed the ``Holy Trinity.'' 
Specifically, on May 9, 2022, June 6, 2022, and June 30, 2022, 
Respondent prescribed 30 mg

[[Page 75325]]

oxycodone, 2 mg alprazolam, and 350 mg carisoprodol. RD, at 14-15; Tr. 
259, 261, 263; GX 4, at 190, 192, 195. Because there was no 
documentation justifying prescribing the ``Holy Trinity,'' Dr. Lobel 
concluded, and the Agency agrees, that the prescriptions were not 
issued within the Georgia standard of care. RD, at 15; Tr. 260, 262, 
264.\7\ Accordingly, the ALJ found, and the Agency agrees, that the 
prescriptions were not issued for a legitimate medical purpose by a 
practitioner acting in the usual course of professional practice. RD, 
at 15.
---------------------------------------------------------------------------

    \7\ Dr. Lobel testified that the documentation for the June 30, 
2022, prescriptions did not support prescribing the ``Holy 
Trinity,'' but the Government did not elicit any testimony regarding 
the adequacy of the documentation for the other two dates for 
Patient T.J. RD, at 15 n.15; Tr. 263.
---------------------------------------------------------------------------

Patient A.A.
    On at least three occasions, Respondent issued prescriptions to 
Patient A.A. that were therapeutically duplicative. Specifically, on 
April 11, 2022, June 6, 2022, and July 6, 2022, Respondent prescribed 
30 mg oxycodone and Percocet. RD, at 15; Tr. 245, 250-251, 255; GX 5, 
at 63, 64, 66. As Dr. Lobel testified, oxycodone and Percocet are both 
immediate release opioids and so prescribing them in combination is 
therapeutic duplication. RD, at 15; Tr. 245-246, 250-251, 257. Because 
there was no documentation justifying the therapeutic duplication, Dr. 
Lobel concluded, and the Agency agrees, that the prescriptions were not 
issued within the Georgia standard of care. RD, at 15; Tr. 246, 249, 
251, 253, 256-258; GX 5, at 37, 38, 40. Accordingly, the ALJ found, and 
the Agency agrees, that the prescriptions were not issued for a 
legitimate medical purpose by a practitioner acting in the usual course 
of professional practice. RD, at 15-16.
Patient L.B.
    On at least three occasions, Respondent issued prescriptions to 
Patient L.B. that were therapeutically duplicative. Specifically, on 
May 15, 2022, June 12, 2022, and July 10, 2022, Respondent prescribed 
30 mg oxycodone and Percocet. RD, at 16; Tr. 221, 235, 238-239, 241-
242; GX 6, at 35, 37, 39. Because there was no documentation justifying 
the therapeutic duplication, Dr. Lobel concluded, and the Agency 
agrees, that the prescriptions were not issued within the Georgia 
standard of care. RD, at 16; Tr. 236, 239 241; GX 5, at 36, 38, 40. 
Accordingly, the ALJ found, and the Agency agrees, that the 
prescriptions were not issued for a legitimate medical purpose by a 
practitioner acting in the usual course of professional practice. RD, 
at 16.
Patient A.T.
    On at least three occasions, Respondent issued prescriptions to 
Patient A.T. that were therapeutically duplicative. Specifically, on 
April 6, 2022, May 4, 2022, and June 2, 2022, Respondent prescribed 30 
mg oxycodone and Percocet. RD, at 16; Tr. 220-221, 225, 226, 228-229; 
GX 7, at 86, 87, 88. Because there was no documentation justifying the 
therapeutic duplication, Dr. Lobel concluded, and the Agency agrees, 
that the prescriptions were not issued within the Georgia standard of 
care. RD, at 16-17; Tr. 221-222, 226-227, 231; GX 7, at 31-33. 
Accordingly, the ALJ found, and the Agency agrees, that the 
prescriptions were not issued for a legitimate medical purpose by a 
practitioner acting in the usual course of professional practice. RD, 
at 17.

I. Discussion

A. The Five Public Interest Factors

    Under the CSA, ``[a] registration . . . to . . . dispense a 
controlled substance . . . may be suspended or revoked by the Attorney 
General upon a finding that the registrant . . . has committed such 
acts as would render his registration under section 823 of this title 
inconsistent with the public interest as determined under such 
section.'' 21 U.S.C. 824(a). In making the public interest 
determination, the CSA requires consideration of the following factors:
    (A) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (B) The [registrant's] experience in dispensing, or conducting 
research with respect to controlled substances.
    (C) The [registrant's] conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (D) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (E) Such other conduct which may threaten the public health and 
safety. 21 U.S.C. 823(g)(1).
    DEA considers these public interest factors in the disjunctive. 
Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor is 
weighed on a case-by-case basis. Morall v. Drug Enf't Admin., 412 F.3d 
165, 173-74 (D.C. Cir. 2005). Any one factor, or combination of 
factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508 
(1993).
    The Government has the burden of proof in this proceeding. 21 CFR 
1301.44. While the Agency has considered all of the public interest 
factors in 21 U.S.C. 823(g)(1), the Government's evidence in support of 
its prima facie case for revocation of Respondent's registration is 
confined to Factors B and D. RD, at 18; see also RD, at 18 n.20 
(finding that Factors A, C, and E do not weigh for or against 
revocation).
    Having reviewed the record and the RD, the Agency agrees with the 
ALJ, adopts the ALJ's analysis, and finds that the Government's 
evidence satisfies its prima facie burden of showing that Respondent's 
continued registration would be ``inconsistent with the public 
interest.'' 21 U.S.C. 824(a)(4). RD, at 17-23.

B. Factors B and D

    Evidence is considered under Public Interest Factors B and D when 
it reflects compliance (or non-compliance) with laws related to 
controlled substances and experience dispensing controlled substances. 
See Sualeh Ashraf, M.D., 88 FR 1095, 1097 (2023); Kareem Hubbard, M.D., 
87 FR 21156, 21162 (2022). DEA regulations require that for a 
prescription for a controlled substance to be effective, it must be 
issued for a legitimate medical purpose by an individual practitioner 
acting in the usual course of professional practice. 21 CFR 1306.04(a); 
see also 21 U.S.C. 829. Georgia state law too provides that a 
practitioner may only issue prescriptions while acting in the usual 
course of his professional practice and for a legitimate medical 
purpose. Ga. Code Ann. section 16-13-41(f)(2), (3).
    In the current matter, the Agency agrees with the ALJ's analysis 
that Respondent's treatment of the six patients described above fell 
below the Georgia standard of care and thus violated Federal and State 
law because, as detailed above, Respondent continually prescribed the 
``Holy Trinity'' and duplicative therapies while failing to establish a 
medical justification for the prescriptions; as such, Respondent's 
prescribing was not within the usual course of professional practice 
and not for a legitimate medical purpose.\8\ RD, at 20-21. As

[[Page 75326]]

Respondent's conduct displays clear violations of the Federal and State 
regulations described above, the Agency agrees with the ALJ and hereby 
finds that Respondent violated 21 U.S.C. 829; 21 CFR 1306.04(a); and 
Ga. Code Ann. section 16-13-41(f)(2), (3). Id. Accordingly, the Agency 
agrees with the ALJ and finds that Factors B and D weigh in favor of 
revocation of Respondent's registration and thus finds Respondent's 
continued registration to be inconsistent with the public interest in 
balancing the factors of 21 U.S.C. 823(g)(1). Id. at 23.
---------------------------------------------------------------------------

    \8\ The Agency also agrees with the ALJ's conclusion that none 
of Respondent's arguments--including, among others, that the case 
was initially based on unfounded criminal allegations; that the 
patients suffered no injuries as a result of Respondent's treatment; 
that the Government's case was only an attack on Respondent's 
recordkeeping; that both public and private insurance companies saw 
fit to cover Respondent's treatments; and that none of Respondent's 
patients engaged in illicit activity--refute this analysis. RD, at 
21-23.
---------------------------------------------------------------------------

III. Sanction

    Where, as here, the Government has established sufficient grounds 
to revoke Respondent's registration, the burden shifts to the 
registrant to show why he can be entrusted with the responsibility 
carried by a registration. Garret Howard Smith, M.D., 83 FR 18882, 
18910 (2018). 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) (internal 
quotations omitted). 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,\9\ 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).
---------------------------------------------------------------------------

    \9\ The record shows that in 2006, Respondent entered into a 
Memorandum of Understanding (MOU) with DEA in which Respondent 
admitted to prescribing controlled substances arguably in violation 
of generally accepted standard practices and Federal regulations; 
prescribing a large number of narcotics, with over half of his 1,500 
patients prescribed narcotics; and keeping samples of controlled 
substances at an unregistered location. RD, at 3; Tr. 24; GX 12.
---------------------------------------------------------------------------

    Here, the Agency agrees with the ALJ that ``Respondent's hearing 
testimony and post-hearing arguments constitute a blanket denial of any 
wrongdoing.'' RD, at 25. Notably, Respondent testified that he did 
``everything [he is] supposed to do as far as the Georgia requirements 
for pain management'' and that ``[t]his hobgoblin of a drug problem 
exists primarily in the mind of an easily excitable DEA.'' Id. at 24-
25; Tr. 350; Respondent's Post-Hearing Brief, at 6. As stated by the 
ALJ, ``Respondent's testimony and argument simply cannot be reconciled 
with the record evidence.'' RD, at 25. As such, and because Respondent 
made no admittance of any wrongdoing on his part, the Agency agrees 
with the ALJ and finds that Respondent failed to unequivocally accept 
responsibility. Id.
    When a registrant fails to make the threshold showing of acceptance 
of responsibility, the Agency need not address the registrant's 
remedial measures. Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019) 
(citing Jones Total Health Care Pharmacy, L.L.C. & SND Health Care, 
L.L.C., 81 FR 79188, 79202-03 (2016)); Daniel A. Glick, D.D.S., 80 FR 
74800, 74801, 74810 (2015). Even so, in the current matter, Respondent 
did not present any evidence of remedial measures, and the Agency thus 
agrees with the ALJ that ``[Respondent's] failure to put forth any 
evidence of steps he has taken to avoid similar misconduct in the 
future shows that he cannot be entrusted with a [registration].'' RD, 
at 26.
    In addition to acceptance of responsibility, the Agency considers 
both specific and general deterrence when determining an appropriate 
sanction. Daniel A. Glick, D.D.S., 80 FR at 74810. In this case, the 
Agency agrees with the ALJ that ``failing to impose a significant 
sanction against Respondent would send the wrong message to registrants 
that the Agency does not take seriously a registrant who repeatedly 
prescribes dangerous drug cocktails and combinations.'' RD, at 26. 
Regarding Respondent in particular, ``[g]iven Respondent's cavalier 
attitude regarding the standard of care, specific deterrence is 
necessary.'' Id. Moreover, the Agency agrees with the ALJ that 
Respondent's actions were egregious because Respondent not only ignored 
his obligations to issue prescriptions within the standard of care and 
instead prescribed combinations that he knew to be dangerous to his 
patients, but he also endangered the community at large given the risk 
of diversion when prescribing such combinations. Id.
    In sum, Respondent has not offered any credible evidence on the 
record to rebut the Government's case for revocation of his 
registration and Respondent has not demonstrated that he can be 
entrusted with the responsibility of registration. RD, at 27. 
Accordingly, the Agency will order that Respondent's registration be 
revoked.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. 
BS4103610 issued to Isaac Sved, M.D. Further, pursuant to 28 CFR 
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I 
hereby deny any pending applications of Isaac Sved, M.D., to renew or 
modify this registration, as well as any other pending application of 
Isaac Sved, M.D., for additional registration in Georgia. This Order is 
effective December 4, 2023.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
October 25, 2023, 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. 2023-24153 Filed 11-1-23; 8:45 am]
BILLING CODE 4410-09-P

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