Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Justice

###### Drug Enforcement Administration

                    On July 10, 2023, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to Henry Manning Pickett, M.D., (Respondent) of Lakewood, Colorado. Request for Final Agency Action (RFAA), Exhibit (RFAAX) 1, at 1. The OSC/ISO informed Respondent of the immediate suspension of his DEA Certificate of Registration, Control No. AP1388948, 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's continued registration is inconsistent with the public interest.                     *Id.*                     (citing 21 U.S.C. 823(g)(1), 824(a)(4)).                

                    The OSC/ISO notified Respondent of his right to file with DEA a written request for hearing within 30 days after the date of receipt of the OSC/ISO; the OSC/ISO also notified Respondent that if he failed to file such a request, he would be deemed to have waived his right to a hearing and be in default.                     *Id.*                     at 8-9 (citing 21 CFR 1301.43). Here, Respondent filed an untimely request for hearing on August 17, 2023,[1]                                          and within his request for hearing, failed to answer the allegations contained in the OSC/ISO as required by 21 CFR 1301.43.                     *See*                     RFAAX 3. On August 17, 2023, Chief Administrative Law Judge John J. Mulrooney, II, (the Chief ALJ) issued an Order requiring Respondent to, among other things, answer the allegations by August 23, 2023.                     *See*                     RFAAX 4. Respondent failed to file answers to the allegations or to otherwise respond to the order. Ultimately, the Chief ALJ determined that Respondent was in default, and on August 28, 2023, issued an Order Terminating Proceedings.                     *See*                     RFAAX 5. “A default, unless excused, shall be deemed to constitute a waiver of the registrant's/applicant's right to a hearing                           ( print page 13377)                        and an admission of the factual allegations of the [OSC].” 21 CFR 1301.43(e).                

                    Further, “[i]n the event that a registrant . . . is deemed to be in default . . . DEA may then file a request for final agency action with the Administrator, along with a record to support its request. In such circumstances, the Administrator may enter a default final order pursuant to [21 CFR] § 1316.67.”                     *Id.*                     § 1301.43(f)(1). Here, the Government has requested final agency action based on Respondent's default pursuant to 21 CFR 1301.43(c), (f).                     *See also id.*                     § 1316.67.                

## I. Findings of Fact

The Agency finds that, in light of Respondent's default, the factual allegations in the OSC/ISO are admitted.

### Colorado Standard of Care

                    Respondent is deemed to have admitted that the applicable standard of care for the practice of medicine in Colorado indicates that prior to prescribing opioid medication, a physician must, among other things: (1) establish a bona fide provider-patient relationship; (2) establish a diagnosis and legitimate medical purpose through performing a history, physical exam, laboratory imaging, and other studies; (3) assess the risk of opioid therapy, including identifying patient and family history and medication history through review of Prescription Drug Monitoring Program (PDMP) data; (4) assess the patient's pain for its nature, intensity, type, frequency, duration, and impact on function; (5) assess the patient's functional ability during treatment and prior to change in medications; (6) consider referrals to other providers for mental health assessments if necessary; and (7) review the PDMP patient profile. RFAAX 1, at 2. Further, Respondent admits that the applicable standard of care provides that clinicians should continue opioid therapy only if there is a clinically meaningful improvement in pain and function that outweighs the risk to patient safety and should practice particular caution when co-prescribing opioid pain medication with benzodiazepines or muscle relaxants and/or sedative hypnotics.                     *Id.*                     at 2-3.                

### Patient N.B.

                    According to the OSC/ISO, between June 2021 and October 2022, Respondent issued prescriptions for controlled substances to Patient N.B. on an approximately monthly basis; these prescriptions included prescriptions for fentanyl 50 mg (a schedule II opioid), zolpidem tartrate 10 mg (a schedule IV sedative), oxycodone/acetaminophen 10/325 mg (a schedule II opioid), alprazolam 2 mg (a schedule IV benzodiazepine), and tramadol 50 mg (a schedule V opioid). RFAAX 1, at 3. Respondent has admitted that he issued these prescriptions without conducting an appropriate evaluation, without appropriately establishing a medical justification, without proper medical records, and without conducting proper ongoing monitoring of the patient.                     *Id.*                     Respondent has also admitted that he did not issue the above-referenced controlled substance prescriptions for a legitimate medical purpose in the usual course of professional practice.                     *Id.*                     at 4.                

### Patient K.C.

                    According to the OSC/ISO, between June 2021 and February 2023, Respondent issued prescriptions for controlled substances to Patient K.C. on an approximately monthly basis; these prescriptions included prescriptions for oxycodone 30 mg (a schedule II opioid), carisoprodol 350 mg (a schedule IV muscle relaxant) and pregabalin 300 mg (a schedule V anti-convulsant).                     *Id.*                     at 4. Respondent has admitted that he issued these prescriptions without conducting an appropriate evaluation, without appropriately establishing a medical justification, without proper medical records, and without conducting proper ongoing monitoring of the patient.                     *Id.*                     Respondent has also admitted that he did not issue the above-referenced controlled substance prescriptions for a legitimate medical purpose in the usual course of professional practice.                     *Id.*

### Patient B.M.

                    According to the OSC/ISO, between June 2021 and March 2023, Respondent issued prescriptions for controlled substances to Patient B.M. on an approximately monthly basis; these prescriptions included prescriptions for oxycodone 10 mg, alprazolam 2 mg, oxycodone/acetaminophen 10/325 mg, OxyContin 30 mg (a brand name drug containing an extended release formulation of oxycodone), and carisoprodol 350 mg.                     *Id.*                     at 5. Respondent has admitted that he issued these prescriptions without conducting an appropriate evaluation, without appropriately establishing a medical justification, without proper medical records, and without conducting proper ongoing monitoring of the patient.                     *Id.*                     Respondent has also admitted that he did not issue the above-referenced controlled substance prescriptions for a legitimate medical purpose in the usual course of professional practice.                     *Id.*

### Patient R.M.

                    According to the OSC/ISO, between June 2021 and February 2023, Respondent issued prescriptions for controlled substances to Patient R.M. on an approximately monthly basis; these prescriptions included prescriptions for oxycodone 10 mg and 20 mg, zolpidem tartrate 10 mg, and lorazepam 0.5 mg (a schedule IV benzodiazepine).                     *Id.*                     Respondent has admitted that he issued these prescriptions without conducting an appropriate evaluation, without appropriately establishing a medical justification, without proper medical records, and without conducting proper ongoing monitoring of the patient.                     *Id.*                     Respondent has also admitted that he did not issue the above-referenced controlled substance prescriptions for a legitimate medical purpose in the usual course of professional practice.                     *Id.*                     at 6.                

### Patient S.S.

                    According to the OSC/ISO, between June 2021 and February 2023, Respondent issued prescriptions for controlled substances to Patient S.S. on an approximately monthly basis; these prescriptions included prescriptions for oxycodone 10 mg and 20 mg, alprazolam 0.5 mg and 1 mg, lorazepam 0.5 mg, and OxyContin 60 mg.                     *Id.*                     at 6. Respondent has admitted that he issued these prescriptions without conducting an appropriate evaluation, without appropriately establishing a medical justification, without proper medical records, and without conducting proper ongoing monitoring of the patient.                     *Id.*                     Respondent has also admitted that he did not issue the above-referenced controlled substance prescriptions for a legitimate medical purpose in the usual course of professional practice.                     *Id.*

### Patient P.M.

                    According to the OSC/ISO, between June 2021 and March 2023, Respondent issued prescriptions for controlled substances to Patient P.M. on an approximately monthly basis; these prescriptions included prescriptions for oxycodone 30 mg, hydromorphone 4 mg and 8 mg (a schedule II opioid), alprazolam 2 mg, and testosterone 200 mg/ml (a schedule III steroid).                     *Id.*                     at 6-7. Respondent has admitted that he issued these prescriptions without conducting an appropriate evaluation, without appropriately establishing a medical justification, without proper medical records, and without conducting proper ongoing monitoring of the patient.                     *Id.*                     at 7. Respondent has also admitted that he did not issue the above-referenced controlled substance prescriptions for a legitimate medical                           ( print page 13378)                        purpose in the usual course of professional practice.                     *Id.*

### Patient D.J.

                    According to the OSC/ISO, between June 2021 and December 2022, Respondent issued prescriptions for controlled substances to Patient D.J. on an approximately monthly basis; these prescriptions included prescriptions for oxycodone 30 mg and lorazepam 2 mg.                     *Id.*                     Respondent has admitted that he issued these prescriptions without conducting an appropriate evaluation, without appropriately establishing a medical justification, without proper medical records, and without conducting proper ongoing monitoring of the patient.                     *Id.*                     Respondent has also admitted that he did not issue the above-referenced controlled substance prescriptions for a legitimate medical purpose in the usual course of professional practice.                     *Id.*                     at 8.                

## II. Discussion

### A. The Five Public Interest Factors

Under the Controlled Substances Act (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).

                    The Agency 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).                

                    While the Agency has considered all of the public interest factors in 21 U.S.C. 823(g)(1),[2]                                          the Government's evidence in support of its                     *prima facie*                     case for revocation of Respondent's registration is confined to Factors B and D.                     *See*                     RFAAX 1, at 2-8. Moreover, the Government has the burden of proof in this proceeding. 21 CFR 1301.44.                

                    Here, the Agency 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).                

### 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). In the current matter, the Government has alleged that Respondent violated both federal and state law regulating controlled substances. RFAAX 1, at 2-8. Specifically, federal law states that “[a] prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a). Further, Colorado state law defines “unprofessional conduct” as “[a]dministering, dispensing, or prescribing any habit-forming drug or any controlled substance . . . other than in the course of legitimate professional practice,” as well as “[a]ny act or omission that fails to meet generally accepted standards of medical practice.” Colo. Rev. Stat. section 12-240-121(1)(c), (j).                

Here, Respondent has admitted that he repeatedly issued prescriptions for controlled substances without conducting appropriate evaluations, without appropriately establishing medical justifications, without taking and keeping proper medical records, and without conducting proper ongoing monitoring of his patients. Respondent further admitted that none of the above-referenced controlled substance prescriptions were issued for a legitimate medical purpose or in the usual course of professional practice. As such, the Agency finds that Respondent repeatedly violated 21 CFR 1306.04(a) and Colorado Revised Statutes section 12-240-121(1)(c).

                    Accordingly, the Agency 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). The Agency further finds that Respondent failed to provide any evidence to rebut the Government's                     *prima facie*                     case.                

## III. Sanction

                    Where, as here, the Government has established grounds to revoke Respondent's registration, the burden shifts to Respondent 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 respondent 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, 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, although Respondent initially requested a hearing, he repeatedly failed to answer the allegations contained in the OSC/ISO, failed to file any other responses as directed by the Chief ALJ, and did not otherwise avail himself of the opportunity to refute the Government's case. As such, Respondent has made no representations as to his future compliance with the CSA nor made any demonstration that he can be entrusted                           ( print page 13379)                        with registration. Moreover, the evidence presented by the Government shows that Respondent violated the CSA, further indicating that Respondent cannot be entrusted.                

Accordingly, the Agency will order the revocation of Respondent's registration.

## Order

Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. AP1388948 issued to Henry Manning Pickett, 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 Henry Manning Pickett, M.D., to renew or modify this registration, as well as any other pending application of Henry Manning Pickett, M.D., for additional registration in Colorado. This Order is effective March 25, 2024.

## Signing Authority

                    This document of the Drug Enforcement Administration was signed on February 14, 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.

# Footnotes

1.                             Based on the Government's submissions in its RFAA dated August 29, 2023, the Agency finds that service of the OSC/ISO on Registrant was adequate and rendered on July 11, 2023. Specifically, on August 23, 2023, the Government filed a Notice of Service and Motion to Dismiss Request for Hearing as Untimely and to Terminate Proceedings, which included as an attachment the Declaration of a DEA Diversion Investigator asserting that on July 11, 2023, Registrant was personally served with the OSC/ISO at his registered address. RFAAX 2, at 1, 3, 13.                    
        Back to Citation      

2.                             As to Factor A, the record contains no evidence of a recommendation from any state licensing board or professional disciplinary authority. 21 U.S.C. 823(g)(1)(A). Nonetheless, an absence of such evidence “does not weigh for or against a determination as to whether continuation of the [registrant's] DEA certification is consistent with the public interest.”                         *Roni Dreszer, M.D.,*76 FR 19434, 19444 (2011). As to Factor C, there is no evidence in the record that Registrant has been convicted of an offense under either federal or state law “relating to the manufacture, distribution, or dispensing of controlled substances.” 21 U.S.C. 823(g)(1)(C). However, as Agency cases have noted, there are a number of reasons why a person who has engaged in criminal misconduct may never have been convicted of an offense under this factor.                         *Dewey C. MacKay, M.D.,*75 FR 49956, 49973 (2010). Agency cases have therefore found that “the absence of such a conviction is of considerably less consequence in the public interest inquiry” and is therefore not dispositive.                         *Id.*                         Finally, as to Factor E, the Government's evidence fits squarely within the parameters of Factors B and D and does not raise “other conduct which may threaten the public health and safety.” 21 U.S.C. 823(g)(1)(E). Accordingly, Factor E does not weigh for or against Registrant.                    
        Back to Citation      

[FR Doc. 2024-03548 Filed 2-21-24; 8:45 am]

BILLING CODE 4410-09-P