No DEA waiver for psilocybin under Right to Try
On February 13, 2025, in another setback for common sense drug policy, the Ninth Circuit Court of Appeals issued a decision in Advanced Integrative Medical Science Institute (AIMS) et al. v. United States Drug Enforcement Administration (DEA), rejecting AIMS's well-articulated arguments. The petition challenged the DEA's denial of a request seeking a waiver for Dr. Sunil Aggarwal from registration under the Controlled Substances Act (CSA). This exemption would have allowed Dr. Aggarwal to administer psilocybin to terminally ill patients under federal and state Right to Try (RTT) laws. The court upheld the DEA's decision, marking a setback for advocates seeking greater access to psilocybin-assisted therapies for palliative care patients.
Background on AIMS v. DEA
Since 2021, AIMS and its co-director, Dr. Aggarwal, have been battling DEA over their attempt to provide terminally ill patients with access to psilocybin under RTT. Specifically, AIMS asked the DEA to determine that Dr. Aggarwal's proposed use of psilocybin was not subject to the CSA's registration requirements or, alternatively, to grant a waiver of those requirements in this unique circumstance under 21 U.S.C. 822(d). Under 822(d), the DEA, or rather the Attorney General, has the authority to issue such a waiver but declined to do so.
DEA argued it could not grant Dr. Aggarwal's request because RTT does not authorize waiving CSA requirements. Shane Pennington, one of AIMS's attorneys, disagreed, stating this interpretation "is at odds with the plain meaning of the Right to Try Act." He explained that under the definition of an eligible investigational drug, "there is no way to say that it doesn't cover psilocybin."
The DEA ultimately decided that granting a waiver to Dr. Aggarwal, a respected physician with existing DEA registrations for Schedule II-V substances, would be "too great a departure from current law and inconsistent with public health and safety." Instead, it argued that Dr. Aggarwal needs to receive a Schedule I registration, which would allow him to conduct research with psilocybin. Unfortunately, Dr. Aggarwal's is not trying to conduct research, but rather, end-of-life compassionate care.
After DEA issued its final decision, AIMS sought review by the Ninth Circuit, arguing that DEA's denial was arbitrary and capricious. The Ninth Circuit disagreed, stating that DEA had "articulated several reasons for its denial . . . that taken together, provide a reasonable explanation as to why it cannot or will not exercise its discretion." The court sided with DEA, finding that Dr. Aggarwal was required to receive a DEA Schedule I research registration before providing psilocybin to patients under RTT. The court found that while RTT exempts FDA approval, it does not exempt FDA's Attorney-General-delegated oversight under the CSA.
Setback for public policy and terminally ill patients
This decision by the Ninth Circuit is another setback for public policy and terminally ill patients. It supports the DEA's contention that the only way to administer Schedule I substances under RTT is through a research study. This appears to run counter to RTT's intent as it substantially limits access of Schedule I substances to dying patients. Some doctors just want to provide compassionate care to their terminally ill patients. They don't necessarily want, or have the resources, to run a DEA/FDA research study.
By upholding the DEA's refusal to grant a waiver, the court denies dying patients access to potentially transformative therapies. Psilocybin has shown promise in alleviating anxiety and depression for those facing the end of life. The decision undermines RTT's intent, which aims to provide terminally ill patients with access to investigational treatments. It prioritizes rigid regulatory adherence over compassionate care, leaving patients to endure unnecessary suffering where care is needed most. Research increasingly supports psilocybin's benefits in palliative care, yet this ruling stifles progress. It disregards the dignity and autonomy of patients in their final days, perpetuating avoidable hardship.
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