Peter Dashkoff, M.D.; Decision and Order

2 months ago 3

I. Introduction

On September 9, 2024, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to Peter Dashkoff, M.D., of Yuma, Arizona (Respondent). OSC/ISO, at 1. The OSC/ ( printed page 19314) ISO informed Respondent of the immediate suspension of his DEA Certificate of Registration (Registration) No. FD3660304, 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's continued registration is inconsistent with the public interest. Id. at 1 (citing 21 U.S.C. 823(g)(1), 824(a)(4)).[1]

Specifically, the Government alleges that on June 26, 2024, Respondent issued four [2] controlled substance prescriptions after he was prohibited from engaging in the practice of medicine in the State of Arizona. Id. at 3. The OSC/ISO alleged that these prescriptions were issued outside the usual course of professional practice and violated federal and state law. Id. at 2-3 (citing 21 U.S.C. 1306.04(a), Ariz. Rev. Stat. Ann. secs. 36-2522(A), 32-3227(F) & (G)).

Respondent requested a hearing, which was held before DEA Administrative Law Judge (ALJ) Teresa Wallbaum, who on January 16, 2025, issued her Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the ALJ (RD). The RD recommended that Respondent's registration be suspended for six months. RD, at 20. Both the Government and Respondent filed timely Exceptions to the RD.[3]

Having reviewed the entire record, the Agency adopts and hereby incorporates by reference the ALJ's credibility findings,[4] findings of fact, and conclusions of law, and clarifies and expands upon portions thereof herein. However, the Agency has determined that revocation is the appropriate sanction based on Respondent's tenuous acceptance of responsibility and the Agency's interest in deterring similar acts on the part of other registrants.

II. Applicable Law

As already discussed, the OSC/ISO alleges that Respondent violated multiple provisions of the Controlled Substances Act (CSA) and its implementing regulations. As the Supreme Court stated in Gonzales v. Raich, “the main objectives of the CSA were to conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances. . . . To effectuate these goals, Congress devised a closed regulatory system making it unlawful to . . . dispense[ ] or possess any controlled substance except in a manner authorized by the CSA.” 545 U.S. 1, at 12-13 (2005). In maintaining this closed regulatory system, “[t]he CSA and its implementing regulations set forth strict requirements regarding registration, . . . drug security, and recordkeeping.” Id. at 14.

The OSC/ISO's allegations concern the CSA's “statutory and regulatory provisions . . . mandating . . . compliance with . . . prescription requirements” and, therefore, go to the heart of the CSA's “closed regulatory system” specifically designed “to conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances,” and “to prevent the diversion of drugs from legitimate to illicit channels.” Id. at 12-14, 27.

The Allegation That Respondent Issued Prescriptions Outside the Usual Course of Professional Practice

According to the CSA's implementing regulations, a lawful prescription for controlled substances is one that is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a); see Gonzales v. Oregon, 546 U.S. 243, 274 (2006); United States v. Hayes, 595 F.2d 258 (5th Cir. 1979), rehearing den., 598 F.2d 620 (5th Cir. 1979), cert. denied, 444 U.S. 866 (1979); OSC/ISO, at 2. Under the CSA, “[a] physician who engages in the unauthorized practice of medicine is not a `practitioner acting in the usual course of professional practice.' ” United Prescription Servs., Inc.,72 FR 50397, 50407 (2007) (citing 21 CFR 1306.04(a)); see also Gonzales v. Oregon, 546 U.S. at 270 (“The very definition of a `practitioner' eligible to prescribe includes physicians `licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices' to dispense controlled substances. § 802(21).”); OSC/ISO, at 2. Moreover, it is unlawful for an individual who is not licensed to practice medicine in a state to issue a prescription for a controlled substance. United Prescription Servs., Inc., 72 FR at 50407 (citing 21 CFR 1306.03(a)(1)).[5]

In order to lawfully prescribe a controlled substance in Arizona, a person “must first . . . [o]btain and possess a current license or permit as a medical practitioner . . . .” Ariz. Rev. Stat. Ann. sec. 36-2522(A)(1); see also OSC/ISO, at 1. An individual who is not “licensed and authorized by law to use and prescribe drugs” is not a “medical practitioner.” Ariz. Rev. Stat. Ann. sec. 32-1901. Arizona defines the “unauthorized practice of a health profession” as “engag[ing] in the practice of a health profession without having the licensure or certification required to practice in that health profession in this state.” Ariz. Rev. Stat. Ann. sec. 32-3227 (G); OSC/ISO, at 2.

III. Findings of Fact

The Allegation That Respondent Issued Prescriptions Outside the Usual Course of Professional Practice

Respondent is a medical doctor in the state of Arizona. RD, at 2. On April 2024, Respondent entered into a first Interim Consent Agreement with the Arizona Medical Board (Board), which required Respondent to comply with certain terms in order to continue practicing medicine in the State of Arizona. GX 3; see also Tr. at 57-58; RD, at 6. Respondent failed to comply with these terms, and shortly thereafter, the Board of Arizona offered him a second Interim Consent Agreement, which prohibited him “from engaging in the practice of medicine in the State of Arizona . . . .” GX 4; see also RD, at 6-7. Respondent's counsel received a copy of the second Interim Consent Agreement on June 21, 2024, and Respondent testified that he learned on June 24, 2024, that he would be restricted from practicing medicine if he and the Board's Executive signed the Interim Consent Agreement. Tr. 70; see also RD, at 6-7. By its own terms, the Interim Consent Agreement would become effective “on the date signed by the Board's Executive Director.” GX 4; see also RD, at 4.

Respondent signed the second Interim Consent Agreement on June 26, 2024, ( printed page 19315) and emailed the signed agreement to the Board at 3:49 p.m. (MST). GX 13; see also RD, at 6-7. Thereafter, the Board's Executive Director signed the agreement and emailed the fully-executed version to Respondent at 4:48 p.m. (MST). GX 14; Tr. 84; see also RD, at 4. The Agency finds substantial record evidence that Respondent's authority to prescribe controlled substances in Arizona lapsed on January 26, 2024, at 4:48 p.m. RD, at 4.

The Agency finds substantial record evidence that after Respondent's state authority lapsed, Respondent issued four prescriptions for controlled substances: (1) a prescription for lorazepam (a schedule IV benzodiazepine), issued to Patient R.B. at 5:53 p.m.; (2) a prescription for morphine (a schedule II opioid), issued to Patient R.B. at 5:53 p.m.; (3) a prescription for morphine, issued to Patient D.H. at 5:53 p.m.; and (4) a prescription for lorazepam, issued to Patient B.T. at 6:23 p.m. GX 6, 11; see also RD, at 4. At the hearing, Respondent acknowledged that his state authority had lapsed when he wrote these prescriptions. See Transcript (Tr.) at 84; RD, at 10-11; see also Respondent's Post-Hearing Brief, at 1-2.[6]

Accordingly, the Agency finds substantial record evidence that Respondent issued four prescriptions for controlled substances without possessing the requisite state authority to prescribe controlled substances in the State of Arizona.

IV. Discussion

A. The Five Public Interest Factors

Under Section 304 of the CSA, “[a] registration . . . to . . . distribute[ ] or 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 . . . [21 U.S.C. 823] inconsistent with the public interest as determined by such section.” 21 U.S.C. 824(a)(4). In the case of a “practitioner,” Congress directed the Attorney General to consider five factors in making the public interest determination. 21 U.S.C. 823(g)(1)(A-E).[7] The five factors are considered in the disjunctive. Gonzales v. Oregon, 546 U.S. 243, 292-93 (2006) (Scalia, J., dissenting) (“It is well established that these factors are to be considered in the disjunctive,” citing In re Arora,60 FR 4447, 4448 (1995)); Robert A. Leslie, M.D.,68 FR 15227, 15230 (2003). Each factor is weighed on a case-by-case basis. 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. Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490 (D.C. Cir. 2007); Morall, 412 F.3d. at 185 n.2; David H. Gillis, M.D.,58 FR 37507, 37508 (1993).

In this matter, while all of the 21 U.S.C. 823(g)(1) factors have been considered, the Agency finds that the Government's evidence in support of its prima facie case is confined to Factors B and D. See RD, at 11. Moreover, the Government has the burden of proof in this proceeding. 21 CFR 1301.44. The Agency agrees with the ALJ and finds that the Government's evidence satisfies its prima facie burden of showing that Respondent's registration would be “inconsistent with the public interest.” 21 U.S.C. 823(g)(1); RD, at 11.

B. Allegation That Respondent's Registration Is Inconsistent With the Public Interest

Factors B and/or D—Respondent Experience in Dispensing Controlled Substances and Compliance With Applicable Laws Related to Controlled Substances

Evidence is considered under Public Interest Factors B and D when it reflects compliance or non-compliance with federal and local laws related to controlled substances and experience dispensing controlled substances. 21 U.S.C. 823(g)(1)(B) and (D); see also Kareem Hubbard, M.D.,87 FR 21156, 21162 (2022). Here, as found above, the Agency agrees with the ALJ and finds that substantial record evidence that Respondent issued four prescriptions for controlled substances without possessing the requisite state authority to prescribe controlled substances in the State of Arizona in violation of Ariz. Rev. Stat. Ann. secs. 36-2522(A). Accordingly, the Agency finds substantial record evidence that these prescriptions were issued outside the usual course of professional practice and violated federal and state laws, namely 21 CFR 1306.4(a), and Ariz. Rev. Stat. Ann. secs. 36-2522(A).

The Agency finds that Factors B and D weigh in favor of revocation of Respondent's registration and that Respondent's continued registration would be inconsistent with the public interest in balancing the factors of 21 U.S.C. 823(g)(1). Accordingly, the Agency finds that the Government established a prima facie case, that Respondent did not rebut that prima facie case, and that there is substantial record evidence supporting the revocation of Respondent's registration. 21 U.S.C. 823(g)(1).

III. Sanction

Where, as here, the Government has met its prima facie burden of Respondent's registration is inconsistent with the public interest due to its numerous violations pertaining to controlled substances, the burden shifts to Respondent to show why he can be entrusted with a registration. Jones Total Health Care Pharmacy., 881 F.3d 823, 830 (11th Cir. 2018); Morall, 412 F.3d at 174; Garrett Howard Smith, M.D.,83 FR 18882, 18904 (2018). The issue of trust is necessarily a fact-dependent determination based on the circumstances presented by the individual respondent. Jeffrey Stein, M.D.,84 FR 46968, 46972 (2019); see also Jones Total Health Care Pharmacy, 881 F.3d at 833. Moreover, as past performance is the best predictor of future performance, DEA Administrators have required that a registrant who has committed acts inconsistent with the public interest must accept responsibility for those acts and demonstrate that it will not engage in future misconduct. Jones Total Health Care Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995). A registrant's acceptance of responsibility must be unequivocal. Jones Total Health Care Pharmacy, 881 F.3d at 830-31. In addition, a registrant's candor during the investigation and hearing has been an important factor in determining acceptance of responsibility and the appropriate sanction. Id. Further, the Agency has found that the egregiousness and extent of the misconduct are significant factors in determining the appropriate sanction. Id. at 834 & n.4. The Agency has also considered the need to deter similar acts by the ( printed page 19316) respondent and by the community of registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.

A. Acceptance of Responsibility

The Agency agrees with the ALJ that there is substantial record evidence that Respondent failed to unequivocally accept responsibility for his misconduct. RD, at 15. When given several opportunities to accept responsibility at the hearing, Respondent failed to precisely articulate what he did wrong. See Respondent's Post-Hearing Brief, at 5; Tr. 77; RD, at 13. For example, Respondent did not acknowledge that he engaged in unprofessional conduct by violating the consent agreement; instead, he testified that he “was too busy to check [his] email.” Tr. 88; see also RD, at 13-14. Respondent also testified that if given another chance to correct his misconduct, the only adjustment he would have made was to check his email before issuing the prescriptions. Tr. 77; see also RD, at 15. Furthermore, in response to the ALJ's question as to why he neglected to check his email prior to prescribing the controlled substances, Respondent answered that he was working to complete his medical duties, such as “documentation and . . . communicating with [his] nursing staff.” Tr. 87; see also RD, at 15. Significantly, Respondent never admitted that he violated the CSA by prescribing two Schedule II opioids and two Schedule IV benzodiazepine after he had signed the agreement. See RD, at 16-19.

Moreover, when the ALJ asked about his commitment to prevent future diversion of controlled substances, Respondent failed to offer concrete solutions, such as ensuring that he would transition his medical duties prior to losing his state authority. Tr. at 79-80; see RD, 12-15. Instead, Respondent detracted from his acceptance of responsibility by focusing his testimony on when, technically, he lost authority to prescribe medication. He testified that he “knew that the restriction took effect not when [he] signed [the agreement] but when the executive director of the Medical Board signed it.” Tr. 87; see RD, at 13. Respondent also attempted to excuse his misconduct by highlighting the shortage of medical professionals in his community and implying that he had no choice but to issue the prescriptions. Tr. 81-82; see also RD, at 15

Respondent's attempts at the hearing to minimize, justify, and excuse his misconduct detract from his acceptance of responsibility and show that he lacked an understanding of the gravity of his misconduct. See Tr. 77; RD, at 12-14.[8] See Jones Total Health Care Pharmacy, LLC, 881 F.3d at 833 (finding that “it was reasonable for the agency to conclude that [respondent's] failure to clearly acknowledge even unintentional misconduct demonstrated lack of understanding of her legal obligations”).

Regarding these matters, there is no record evidence that Respondent takes responsibility, let alone unequivocal responsibility, for the founded violations. Accordingly, Respondent did not convince the Agency that he would comply with the legal requirements of the CSA in the future or that he can be entrusted with a registration.

B. Deterrence and Egregiousness

In addition to unequivocally accepting responsibility, the Agency considers both specific and general deterrence when determining an appropriate sanction. Daniel A. Glick,80 FR 74800, 74810 (2015). In this case, the Agency agrees with the ALJ and finds substantial evidence that “it must impose a sanction on Respondent to impress upon him that he cannot be negligent in such important matters.” RD, at 19. Respondent was aware that he had signed a legal agreement that restricted his medical practice but failed to adhere to the terms of the agreement. Id., at 19.

The Agency further agrees with the ALJ that the interests of general deterrence compel a similar result. RD, at 18. As the ALJ states, “this tribunal must craft a sanction that sends a message to all registrants that the Agency takes such conduct seriously.” Id., at 18. If the Agency permitted Respondent to retain his registration, it would signal that registrants may be negligent or inattentive to contractual terms and laws that restrict their medical practice, even when those rules are crucial to preventing the abuse and diversion of dangerous controlled substances.[9] Prescribing controlled substances without state authority is an ( printed page 19317) egregious violation of the CSA and an act of diversion.

In sum, Respondent has not offered sufficient credible evidence on the record to rebut the Government's case for revocation, and Respondent has not demonstrated that he can be entrusted with the responsibility of registration. 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) and 21 U.S.C. 823(g)(1), I hereby revoke DEA Certificate of Registration No. FD 3660304 issued to Peter Dashkoff, M.D. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a) and 21 U.S.C. 823(g)(1), I hereby deny any pending applications of Peter Dashkoff, M.D., to renew or modify this registration, as well as any other pending application of Peter Dashkoff, M.D., for additional registration in the state of Arizona. This Order is effective June 6, 2025.

Signing Authority

This document of the Drug Enforcement Administration was signed on May 1, 2025, by Acting Administrator Derek Maltz. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

Heather Achbach,

Federal Register Liaison Officer, Drug Enforcement Administration.

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