Appeals court to hear case on psilocybin use by terminally ill

The Ninth Circuit Court of Appeals is set to hear arguments in August in a closely watched case about whether terminally ill patients have the right to use the psychedelic drug psilocybin under federal and state “right-to-try” laws, Law360 reported.

The case, Advanced Integrative Medical Science Institute v. U.S. Drug Enforcement Administration, was brought by Dr. Sunil Aggarwal, a Seattle physician who’s seeking to provide psilocybin to his dying cancer patients to treat depression and anxiety.

Aggarwal and his clinic argue that laws aimed at allowing terminal patients to try experimental medications should permit the use of psilocybin in this context. The DEA and Justice Department counter that right-to-try statutes don’t override the federal prohibition on the substance.

Oral arguments in the case are scheduled for the morning of Aug. 19 in San Francisco, the Ninth Circuit announced Sunday.

The current appeal is part of a broader effort by Aggarwal to expand access to psilocybin for end-of-life care. The DEA has repeatedly rejected his proposals, arguing that providing the substance would be inconsistent with public health and safety and that Aggarwal must register as a researcher to obtain it.

Aggarwal sued the DEA in 2022, alleging its decisions were arbitrary and contradicted legal precedent allowing limited therapeutic use of other restricted drugs. The agency has insisted that Aggarwal hasn’t provided sufficient evidence and that it can’t fully assess his waiver request without more specifics.

In a separate case, the Ninth Circuit ordered the DEA to clarify its rationale for keeping psilocybin in Schedule I after rejecting a petition by Aggarwal to reclassify it.

Though currently illegal, psilocybin has received “breakthrough therapy” designation from the FDA twice and is now undergoing late-stage clinical trials. Any ruling by the Ninth Circuit in Aggarwal’s case could mean reverberations for its legal status and availability to patients.