The Advanced Integrative Medical Science Institute and its co-director, Dr. Sunil Aggarwal, sought to provide psilocybin to terminally ill patients for anxiety and depression. Psilocybin is classified as a Schedule I controlled substance under the Controlled Substances Act, meaning it has no accepted medical use and requires special registration for research. Dr. Aggarwal, who is registered to prescribe Schedule II through V drugs, requested an exemption from the CSA's registration requirements or a waiver of those requirements under the Right to Try Act, which allows access to investigational drugs for eligible patients. The DEA responded that the Right to Try Act does not waive CSA requirements and declined to initiate rulemaking to exempt Dr. Aggarwal. The Institute petitioned the Ninth Circuit for review, arguing the denial was arbitrary and capricious.
The court first addressed jurisdiction, applying the two-part test from Bennett v. Spear to determine if the DEA's letter was final agency action. The court found that the letter marked the consummation of the agency's decision-making process and determined the rights and obligations of the petitioners by denying their requests for authorization and immunity. Having established jurisdiction, the court reviewed the denial under the arbitrary and capricious standard of the Administrative Procedure Act. The court rejected the petitioners' argument that the Right to Try Act implicitly waived CSA registration requirements, explaining that the two statutes operate in tandem and the Right to Try Act does not mention the CSA or exempt controlled substances from its oversight. The court also found the DEA's refusal to initiate rulemaking reasonable. The DEA noted the petitioners failed to provide the proposed text or scope of the regulation they sought. Furthermore, the DEA relied on Congress's determination that psilocybin has a high potential for abuse and no accepted medical use, concluding that the proposed therapeutic use was too great a departure from current law. The court also addressed the petitioners' reliance on past DEA practices involving Epidiolex and reverse distributors, finding those examples did not constitute exemptions from registration requirements and were consistent with the existing CSA framework.
The petition is dismissed, leaving the DEA's original denial in full force. Practitioners seeking to dispense Schedule I substances like psilocybin must still register as approved researchers under 21 U.S.C. § 823(f). The decision clarifies that the Right to Try Act does not override CSA registration mandates, though it leaves open the possibility for future rulemaking if a petitioner provides a concrete regulatory proposal.
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