On February 13, 2025, 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), denying AIMS’ petition challenging the DEA’s denial to exempt Dr. Sunil Aggarwal from registration under the Controlled Substance Act (“CSA”) in his efforts to treat certain terminally ill patients with a Schedule I Drug, psilocybin.

Here, AIMS asked the DEA to exempt Dr. Aggarwal from registration under the CSA, either finding that Dr. Aggarwal’s proposed use of psilocybin, a hallucinogen, as part of a cancer treatment regimen, is not covered by the CSA’s registration requirement or by waiving the registration requirement, allowing Dr. Aggarwal to provide the respective care to select  terminally ill patients. The DEA declined to take either action.

Manufacturers, distributors, and dispensers, including practitioners and researchers, who wish to administer drugs with a CSA schedule, must register with the DEA.

AIMS and Dr. Aggarwal justify their request to use psilocybin as a treatment method by citing to the federal Right To Try Act (“RTT”). The spirit of RTT is to allow patients who have exhausted all other types of treatment accesses to “eligible investigational drug” (as defined by the RTT). AIMS identifies psylocibin as a “eligible investigational drug” and the DEA does not contest the same. However,  the Court affirmed the DEA’s position that the RTT does not modify or waive any of the CSA’s registration requirements.

The DEA’s denial seems to contradict its position that a waiver of that requirement must be consistent with “public health and safety”.   See21 U.S.C. § 822(d). The affirmation of the DEA’s denial hamstrings Dr. Aggarwal, as well as other practitioners, by prohibiting them from providing, even with consent, alternative treatments such as psilocybin, to treat conditions, like depression and pain.

Context is important. The DEA’s position is clear that simply because a patient is terminal is not sufficient to obtain a waiver for alternative treatments that will increase the quality of care.

However, the 9^th Circuit’s decision does provide some guidance, although vague, as to how future requests to the DEA could obtain approval. The Court noted how “AIMS did not demonstrate in its letter to the Agency [DEA] how its proposed use of psilocybin was consistent with public health and safety…nor did AIMS describe the treatment plan Dr. Aggarwal envisioned or the safety controls he would implement.”

While it is unfair to play Monday quarterback, one could only wonder if the result may have been different had AIMS taken additional steps to demonstrate to the DEA that Dr. Aggarwal’s proposed psilocybin treatment plan substantively aligned with the public health and safety and AIMS had a treatment plan with the necessary safety controls in place.  Had AMS made such a showing, then perhaps the 9^th Circuit would have been more likely to find the DEA’s decision as “arbitrary and capricious”.

At a minimum, the scope of individual liberty and agency among patients was limited, for the time being, by this 9^th Circuit decision.

Bianchi & Brandt will continue to monitor legal developments in the growing area of psychedelics sciences.  If you have any questions, please feel free to contact us.