Dr. Sunil Aggarwal, a Seattle based physician, sought authorization to obtain psilocybin under the Washington and Federal Right to Try Act for therapeutic use for his palliative care patients. Psilocybin is classified as schedule I on the Controlled Substances Act (CSA) and has been shown in clinical trials to quickly relieve anxiety and depression faster than antidepressants. No supplier would provide Dr. Aggarwal with psilocybin without the Drug Enforcement Administration’s (DEA) permission. Dr. Aggarwal went to the DEA to find out how he could receive approval. He received notification from the DEA that it had no authority to waive any of the CSA’s rules.

Dr. Aggarwal sought judicial review from The United States Court of Appeals for the Ninth Circuit[1]  of that determination. The court dismissed the case.

Dr. Aggarwal then filed a petition that sought review “of the DEA’s denial of his petition to transfer psilocybin from schedule I to schedule II, See 21 U.S.C. § 812(b), pursuant to its authority under 21 U.S.C. § 811(a).”

With respect to the DEA’s denial of Dr. Aggarwal’s request to reschedule psilocybin, the Ninth Circuit found, among other things, that:

  • The DEA failed to provide analysis sufficient to allow its “path” to “reasonably be discerned.”
  • It also failed to “clearly indicate that it has considered the potential problem identified in the petition.”
  • The DEA’s denial letter failed to define “currently accepted medical use with severe restrictions,” U.S.C. § 812(b)(2)(B), the standard applicable to transferring a drug from schedule I to schedule II on which Aggarwal relied.
  • The denial letter did not expressly state that a substance could not meet that standard unless it met the DEA’s five-part test for “currently accepted medical use,” as defined in Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Reg. 53767, 53793 (Aug. 12, 2016).

The Court then held:

Our review of agency action is limited to “the grounds that the agency invoked when it took the action,”… and where those grounds are inadequate, we may remand for either a “fuller explanation of the agency’s reasoning at the time of agency action,”… or for the agency to ‘deal with the problem afresh’ by taking new agency action.” We thus remand for the DEA to either clarify its pathway for denying Aggarwal’s petition or reevaluate Aggarwal’s petition on an open record.


What does that mean for the future of the lawful use of psilocybin?

The Ninth Circuit sent Dr. Aggarwal’s request to review the rescheduling of psilocybin to the DEA to conduct a more in-depth review and to provide a better explanation as to why Dr. Aggarwal’s request to reschedule was denied.

It will likely take months, if not longer, before the DEA addresses the remanded petition, but the Ninth Circuit’s decision is an important one because it requires the DEA to more fully evaluate whether psilocybin should be rescheduled so that it can lawfully be used for medical purposes.

[1] The United States Court of Appeals for the Ninth Circuit is a federal appellate court headquartered in San Francisco, California. The Ninth Circuit consists of the districts of: Alaska, Arizona, California, Hawaii, Idaho Montana, Nevada, Oregon, and Washington.