A federal appeals court directed the U.S. Drug Enforcement Administration to give a detailed explanation for keeping psilocybin, the hallucinogenic compound in psychedelic mushrooms, on the list of the most restricted substances.
The Ninth Circuit Court of Appeals’ decision comes after Dr. Sunil Aggarwal and the Advanced Integrative Medical Science Institute, which he co-founded in Seattle, contested the DEA’s classification of psilocybin as a Schedule I substance, defined as having no accepted medical use and a high potential for abuse.
The DEA initially denied Aggarwal’s petition to reclassify psilocybin to Schedule II, which would allow medical use under severe restrictions, with a brief letter stating the absence of FDA approval for any psilocybin-based treatments. However, the appellate panel noted that such a denial seems at odds with the Controlled Substances Act’s criteria, which allow for a substance to be classified under Schedule II if it has a “currently accepted medical use with severe restrictions” or “a currently accepted medical use in treatment in the United States.”
The three-judge panel did not take a position on the legality of the DEA’s five-part test for determining accepted medical use. Instead, it focused on the agency’s failure to adequately address the evidence Aggarwal presented, which the court found significant.
Kathryn L. Tucker, attorney for Aggarwal and legal director of the National Psychedelics Association, labeled the decision as “a clean, quick, and clear win for petitioners.”
“At the hearing, government counsel suggested cooperation with petitioners is the best path forward. We agree, and given the court’s opinion, we now call upon DEA to refer the petition to FDA immediately,” Tucker t0ld Law360. “Further delay denies dying patients access to an investigational drug shown to provide immediate, substantial and sustained relief from anxiety and depression.”
The move by the Ninth Circuit is seen as a potential stepping stone toward reevaluating the medical benefits of psilocybin within the confines of federal law. The substance has been listed as a Schedule I drug since the 1970s, a category reserved for drugs with no currently accepted medical use and a high potential for abuse.
Support for Aggarwal’s position has seen a coalition of health and advocacy groups, including NORML and the Global Wellness Institute, submitting amicus briefs to the Ninth Circuit.
The DEA now has to reconsider the petition and provide specific reasons for its decision to maintain psilocybin’s Schedule I classification or to begin the process of rescheduling the drug based on medical evidence.