Ninth Circuit

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A three-judge panel on the Ninth U.S. Circuit Court of Appeals refused to hear a lawsuit filed by Dr. Sunil Aggarwal, a hospice physician, and two cancer patients who sought psilocybin, a Schedule I drug, to treat anxiety and depression in terminally ill patients.

Aggarwal’s employer, the Advanced Integrative Medical Sciences (AIMS) Institute, had sought access to use a synthetic form of the psilocybin under the Right to Try Act and similar laws, which allows unapproved treatment options for those with life-threatening diseases or those unable to obtain novel treatments in clinical trials.

The Drug Enforcement Agency (DEA) argued in a letter to AIMS that right-to-try laws do not preempt the Controlled Substances Act

A three-judge panel on the Ninth determined the letter from the DEA did not represent formal guidance and, therefore, the Court lacked jurisdiction to rule on the case.

In an opinion, Judge Sandra S. Ikuta noted that “AIMS’s issue is not with the DEA’s letter, but with the CSA’s criminalization of psilocybin use, subject to narrow exemptions.”

The case was titled Advanced Integrative Medical Science Institute v. U.S. Drug Enforcement Administration, 9th U.S. Circuit Court of Appeals, No. 21-70544.

Several U.S. cities have decriminalized psilocybin, including Seattle, Denver and Oakland and Santa Cruz in California.

The AIMS Institute is based in Seattle.

Maine is considering legalizing psilocybin to treat depression.

FDA designated psilocybin as a breakthrough treatment for severe depression in 2018 and major depressive disorder in 2019.