A Potential Breakthrough for Psychedelic Treatments: Ninth Circuit Court Ruling on Psilocybin Rescheduling

By Jason Adelstone

Dec 7, 2023

On October 27, 2023, the Ninth Circuit Court of Appeals, in Aggarwal v. DEA, held that the U.S. Drug Enforcement Agency (DEA) must reconsider its denial of a petition to transfer psilocybin, the active ingredient in “magic mushrooms” from Schedule I to Schedule II.

The Aggarwal v. DEA case stems from a February 2022 petition by Dr. Sunil Aggarwal, who has been working for years to find a way to legally obtain and administer psilocybin for terminally ill cancer patients under end-of-life care. Dr. Aggarwal initially attempted to seek permission from federal regulators under federal “right-to-try” laws, which allow terminally ill patients to try investigational new drugs that haven’t gone through full Federal Drug Administration (FDA) approval.

After the DEA denied Dr. Aggarwal’s petition, he requested that the DEA initiate a scheduling review of psilocybin to transfer the substance from Schedule I to Schedule II. The DEA classifies controlled substances into five schedules based on their potential for abuse and accepted medical use. Schedule I drugs are considered to have no currently accepted medical use and a high potential for abuse. This classification severely restricts research and therapeutic applications. Moving psilocybin to Schedule II would acknowledge its potential therapeutic benefits and open doors for medical providers to offer this promising treatment to patients.

DEA subsequently denied Dr. Aggarwal’s scheduling review request. However, as the Ninth Circuit noted, the DEA failed to provide any analysis or reasoning behind its decision. The DEA neglected to define “currently accepted medical use with severe restrictions,” the standard for transferring a drug from Schedule I to Schedule II. DEA failed to expressly state and discuss how psilocybin could not meet the requirements of “accepted medical use” under DEA’s five-part test or other applicable method under which DEA would be permitted to make such a determination.

Health and Human Services (HHS), through the FDA, has never determined that psilocybin has an accepted medical use in treatment. However, because of the Ninth Circuit’s holding, we may finally see HHS/FDA conduct a scheduling review of psilocybin. Recently, several studies have strengthened the argument that psilocybin has an accepted medical use in treatment, with more studies likely to be published soon. While the court’s opinion did not go so far as requiring HHS to conduct a scheduling review, the DEA is going to have some difficulty justifying another denial without support from an HHS/FDA review as to the medical and scientific determination of psilocybin.

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