Court Opinion

ID: 9893565
Source: CourtListenerOpinion
Date Created: 2023-10-27 18:00:49.345955+00
Date Added: 2024-06-11T09:04:30.464171
License: Public Domain

FILED
                           NOT FOR PUBLICATION
                                                                            OCT 27 2023
                    UNITED STATES COURT OF APPEALS                       MOLLY C. DWYER, CLERK
                                                                          U.S. COURT OF APPEALS

                           FOR THE NINTH CIRCUIT

Doctor SUNIL AGGARWAL, MD, PhD,                  No. 22-1718
FAAPMR, FAAHPM,
                                                 Drug Enforcement Administration
             Petitioner,

 v.                                              MEMORANDUM *

UNITED STATES DRUG
ENFORCEMENT ADMINISTRATION,

             Respondent,

----------------------------------------
END OF LIFE
WASHINGTON; EVERGREEN
HEALTH; A SACRED
PASSING; PANCREATIC CANCER
NORTH AMERICA; PSYCHEDELICS &
HEALING INITIATIVE OF THE
GLOBAL WELLNESS
INSTITUTE; Professor KATHY
CERMINARA; Professor DAVID
HOFFMAN, J.D.; JILL
SIMONIAN, PharmD; MICHAEL
FRATKIN, M.D.,

       *
             This disposition is not appropriate for publication and is not precedent
except as provided by 9th Cir. R. 36-3.
F.A.A.H.P.M.; VETERAN MENTAL
HEALTH LEADERSHIP COALITION,
INC.; REASON FOR HOPE,
INC.; NATIONAL ORGANIZATION
FOR THE REFORM OF MARIJUANA
LAWS; MANISH
AGRAWAL, M.D.; ANTHONY
BACK, M.D.; YVAN
BEAUSSANT, M.D.; ROLAND R.
GRIFFITHS, Ph.D.; ROBERT
JESSE; ETHAN NADELMANN, JD,
Ph.D.; DAVID NUTT, DM, FRCP,
FRCPsych, FSB, FMedSci; BILL
RICHARDS, Ph.D.; ALDEN DOERNER
RINALDI, M.D.; ZACHARY
SAGER, M.D.; PAUL
THAMBI, M.D.; CAREY TURNBULL,

              Amici Curiae.

                     On Petition for Review of an Order of the
                        Drug Enforcement Administration

                      Argued and Submitted October 20, 2023
                                Phoenix, Arizona

Before: IKUTA, BADE, and BRESS, Circuit Judges.

      Dr. Sunil Aggarwal petitions for review of the Drug Enforcement

Administration’s (DEA) denial of his petition to transfer psilocybin from schedule

I to schedule II, see 21 U.S.C. § 812(b), pursuant to its authority under 21 U.S.C.

§ 811(a). We have jurisdiction under 21 U.S.C. § 877, and we grant the petition.

                                          2
      We must “hold unlawful and set aside agency action, findings, and

conclusions found to be . . . arbitrary, capricious, an abuse of discretion, or

otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A). “[W]here the

agency has failed to provide [a] minimal level of analysis, its action is arbitrary and

capricious and so cannot carry the force of law.” Encino Motorcars, LLC v.

Navarro, 579 U.S. 211, 221 (2016). In denying Aggarwal’s petition, the DEA

failed to provide analysis sufficient to allow its “path” to “reasonably be

discerned.” Gill v. U.S. Dep’t of Just., 913 F.3d 1179, 1187–88 (9th Cir. 2019)

(quoting Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co.,

463 U.S. 29, 43 (1983)). It also failed to “clearly indicate that it has considered the

potential problem identified in the petition.” Compassion Over Killing v. U.S.

Food & Drug Admin., 849 F.3d 849, 857 (9th Cir. 2017). The DEA’s denial letter

failed to define “currently accepted medical use with severe restrictions,” 21

U.S.C. § 812(b)(2)(B), the standard applicable to transferring a drug from schedule

                                           3
I to schedule II on which Aggarwal relied.1 The denial letter did not expressly

state that a substance could not meet that standard unless it met the DEA’s five-

part test for “currently accepted medical use,” as defined in Denial of Petition to

Initiate Proceedings to Reschedule Marijuana, 81 Fed. Reg. 53767, 53793 (Aug.

12, 2016).2 Even if we inferred that the DEA does require a substance to meet the

five-part test for “currently accepted medical use” in order to be transferred to

schedule II, the DEA failed to explain why Aggarwal’s submission did not show

that psilocybin met the five-part test. Nor did the DEA’s letter explain its

reasoning for any such conclusion. Although the DEA addresses some of these

issues on appeal, “[p]ost hoc explanations of agency action by appellate counsel

cannot substitute for the agency’s own articulation of the basis for its decision.”

Arrington v. Daniels, 516 F.3d 1106, 1113 (9th Cir. 2008).

      Our review of agency action is limited to “the grounds that the agency

invoked when it took the action,” Dep’t of Homeland Sec. v. Regents of the Univ.

      1
         Moreover, the denial letter’s statement that “[a] prerequisite to transferring
a substance from schedule I to schedule II under the CSA is for the Food and Drug
Administration (FDA) to determine that a substance has a currently accepted
medical use in treatment in the United States” is contrary to 21 U.S.C.
§ 812(b)(2)(B), which sets as a prerequisite to transfer to schedule II either “a
currently accepted medical use in treatment in the United States” or “a currently
accepted medical use with severe restrictions.”
      2
        We therefore do not decide whether the five-part test for “currently
accepted medical use” is a lawful interpretation of 21 U.S.C. § 812(b)(2)(B).
                                           4
of Cal., 140 S. Ct. 1891, 1907 (2020) (quoting Michigan v. EPA, 576 U.S. 743, 758

(2015)), and where those grounds are inadequate, we may remand for either a

“fuller explanation of the agency’s reasoning at the time of agency action,” id.

(quoting Pension Benefit Guar. Corp. v. LTV Corp., 496 U.S. 633, 654 (1990)), or

for the agency to “‘deal with the problem afresh’ by taking new agency action,” id.

at 1908 (quoting SEC v. Chenery Corp., 332 U.S. 194, 201 (1947)). We thus

remand for the DEA to either clarify its pathway for denying Aggarwal’s petition

or reevaluate Aggarwal’s petition on an open record.3

      PETITION GRANTED.

      3
      Given the inadequacy of the DEA’s denial letter, we do not address
Aggarwal’s argument that 21 U.S.C. § 811(b) requires the DEA to refer
Aggarwal’s petition to the Department of Health and Human Services.
                                          5