Summary
The Ninth Circuit Court of Appeals denied a petition for review challenging the Drug Enforcement Administration's refusal to exempt a physician from Controlled Substances Act registration requirements to prescribe psilocybin under the Right to Try Act. The court determined it had jurisdiction over the DEA's final denial letter and reviewed the decision under the arbitrary and capricious standard of the Administrative Procedure Act. Finding that the agency provided a reasonable explanation grounded in public health and safety concerns and existing statutory frameworks, the panel upheld the DEA's refusal to initiate rulemaking or waive registration.
Topics
Practice areas
Questions Presented
- Whether DEA’s August 19, 2022 letter constitutes a final agency action subject to judicial review under 21 U.S.C. §877.
- Whether DEA’s denial of the petitioners’ request to exempt Dr. Aggarwal from CSA registration requirements was arbitrary and capricious.
Holdings
- The Court held that the letter satisfies the Bennett v. Spear two‑part test and therefore is final agency action, giving the Ninth Circuit jurisdiction to review.
- The Court held that DEA’s denial was not arbitrary or capricious and affirmed the petitioners’ petition for review.
Key quotations
“DEA’s response explained that “practitioners who seek to dispense or possess schedule I controlled substances must be properly registered as an approved researcher in accordance with the CSA and its implementing regulations.”” (at 21)
“The Agency’s explanation of the relationship between the two statutes was therefore neither arbitrary nor capricious.” (at 21)
Factual background
Dr. Sunil Aggarwal, co‑director of the Advanced Integrative Medical Science Institute, sought DEA exemption from the Controlled Substances Act registration requirement so he could provide psilocybin to terminally ill patients. DEA denied the request, stating that the Right to Try Act does not waive CSA requirements and that the agency could not grant a waiver under 21 U.S.C. §822(d).
Procedural history
The petitioners previously sought DEA guidance in 2021 (AIMS I) which the court dismissed for lack of finality. They later submitted a second request in 2022; DEA issued a final denial letter on August 19, 2022. The petitioners filed a petition for review in this Court on September 19, 2022, which is the present appeal.