Will a Court Ruling Push the DEA to Reschedule Psilocybin?

Riding on a judicial victory challenging the US Drug Enforcement Administration's denial of a petition to move psilocybin from schedule I to schedule II, the plaintiffs said they will soon be back in court to try to force the agency to allow the use of the psychedelic under state right-to-try laws, which aim to provide terminally ill patients with access to experimental treatments that have not yet been fully approved by the US Food and Drug Administration .

Attorney Kathryn Tucker, director of advocacy for the National Psychedelics Association, who has also been representing AIMS, said her clients are happy with the Ninth Circuit response. However, they wish the judges had been more directive with the DEA, Tucker told"We are at a moment where one would hope that the agency will finally stop obstructing and delaying and do the right thing," she said.

"It just doesn't seem like there's any possibility that the agency would willingly do anything else before then," said Marks.Tucker said that the next best chance to pressure the agency is through another suit brought by AIMS that seeks to allow use of psilocybin under state right-to-try laws. AIMS and the federal government are submitting briefs, and arguments could be heard as soon as summer 2024, said Tucker., it must have completed an FDA-approved phase 1 clinical trial; be in an active trial that would form the basis of an application for approval or already is part of an approval application; and be in ongoing active development or production and not discontinued by the manufacturer or placed on clinical hold.

"I believe we will prevail," said Tucker. However, Tucker is also a realist. "There is no quick path to victory here," she said.She also noted that several pieces of legislation have been introduced in the US Congress that could help facilitate research and allow compassionate use of psychedelic therapies like psilocybin and 3,4-methylenedioxy would expedite the transfer of substances that receive breakthrough therapy designation from the FDA from schedule I to schedule II.

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