Federal Rescheduling Of Psilocybin For End-Of-Life Cancer Patients Just Hit Another Obstacle

Dr. Sunil Aggarwal’s long-standing battle for the federal rescheduling of psilocybin for end-of-life cancer patients just hit another obstacle.

What Happened: According to Marijuana Moment, the Washington-based doctor began seeking permission to provide the therapy from state and federal regulators under Right-To-Try (RTT) laws back in 2020. RTT laws enable access for patients with terminal diseases to investigational therapies.

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An appellate panel of the U.S. Ninth Circuit Court of Appeals rejected a request for rehearing the court’s former ruling, which returns the psilocybin rescheduling petition to the Drug Enforcement Administration (DEA) instead of sending it to the Food and Drug Administration (FDA) for review, as sought by the doctor’s lawyers.

The rehearing petition was based on claims that the court’s former order omitted the petitioners’ argument that federal statute “requires a referral” to FDA to conduct a “scientific and medical evaluation and scheduling recommendation.” 

Aggarwal’s lawyers said the oversight has both legal and practical ramifications for the petitioners: “If agencies could simply procure naked remands in response to substantive petitions, such a precedent would embolden agencies to avoid making decisions on the merits,” the filing reads. “In other words, such a precedent would incentivize agencies to say less, not more, in initial decisions, multiplying judicial workload and delaying decisions on the merits.” 

Why It Matters: The three-member appellate panel denied the rehearing request, reportedly without explaining why.

As a result, the rescheduling petition is again in DEA’s hands. The DEA could decide to reject the request again, keeping psilocybin’s legal status unchanged.

Precedent Twists And Turns

When the DEA first rejected Aggarwal’s request, the doctor’s party sued the federal agency. The lawsuit was dismissed in early 2022, by a federal appellate panel, on the grounds that the court lacked jurisdiction “because DEA’s rejection of Aggarwal’s administrative request didn’t constitute a reviewable agency action.”

The current 2023 case derives from Aggarwal’s response to 2022’s ruling, a formal petition filed with DEA back in February 2022 to reschedule psilocybin from Schedule I to Schedule II under the federal Controlled Substances Act (CSA). The petition’s denial constitutes a reviewable action.

DEA denied the doctor’s petition again in September 2022.

Aggarwal filed suit yet again in December.

In the October 2023 ruling, the Ninth Circuit panel said DEA’s denial was inadequate, “failed to provide sufficient analysis” and “failed to clearly indicate that it has considered the potential problem identified in the petition.”

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