9th Circuit to Decide Whether the Federal Government Can Continue to Deprive End-of-Life Patients of Psilocybin’s Palliative Benefits

By Joshua S. Bauchner and Rahool Patel

Much ink has been spilled over the past decade about the absurdity of the federal government’s insistence on maintaining marijuana’s listing as a Schedule I drug with “no accepted medical use” under the Controlled Substances Act (CSA) despite ample evidence of and consensus about marijuana’s therapeutic and medical benefits. A similarly illogical and unjust prohibition against the therapeutic use of another drug – psilocybin – is the subject of a current challenge before the United States Court of Appeals for the 9th Circuit. The outcome of this pending litigation will determine whether the Drug Enforcement Administration (DEA) can continue to deprive countless palliative care and end-of-life patients of a therapy that can help them with unrelieved anxiety and depression in their remaining days.

The case, which has taken a long and winding path back to the appellate court, has attracted the interest and involvement of scores of clinicians, patient rights groups, and drug reform advocates. These parties have submitted amicus briefs to support the rescheduling of psilocybin so that dying patients can avail themselves of the relief the drug may provide. Among those groups is the National Organization for the Reform of Marijuana Laws (“NORML”), whose amicus brief was prepared and filed pro bono by Ansell Grimm & Aaron attorneys Joshua S. Bauchner and Rahool Patel.

“A Law Enforcement Agency Lacking Scientific and Medical Expertise Dictating the Outcomes of Drug Scheduling”

The efforts to reschedule psilocybin and the litigation that followed were commenced by Seattle-based physician Dr. Sunil Aggarwal, who asked the DEA to approve the use of the drug for his palliative care patients under the 2018 federal Right to Try (RTT) Act. That law allows certain patients access to investigational drugs outside of clinical trials.

Despite the fact that the Food and Drug Administration (FDA) had twice designated psilocybin as a “breakthrough therapy,” thus making it potentially eligible for use under the RTT, the DEA refused Aggarwal’s request. Aggarwal then asked the 9th Circuit in 2021 to order the DEA to allow him to treat his patients with psilocybin, arguing that the RTT superseded the CSA’s ban on the use of the drug. However, the court dismissed the petition on procedural grounds, as the DEA had not yet issued a final agency decision that would allow for judicial review.

After the dismissal, Aggarwal continued his fight but changed his approach. Instead of challenging the DEA’s decision under the RTT, he affirmatively petitioned the DEA in February 2022 to reschedule psilocybin as a Schedule II drug, which would allow for its therapeutic use.

The DEA was equally unmoved by this effort and summarily rejected Aggarwal’s petition in September 2022, asserting there was no scientific evidence that would justify rescheduling. The pending litigation ensued, in which Aggarwal is asking the 9th Circuit to vacate the DEA’s denial and remand the petition back to the agency on the grounds that the DEA did not follow the required procedure when denying the petition.

Specifically, Aggarwal asserts that the DEA violated the law by failing to consult the FDA to assess psilocybin’s potential uses. As noted, the FDA had previously designated it as “breakthrough therapy,” facilitating research into its potential medical applications. As Aggarwal asserts in his initial brief, “DEA disregarded procedures Congress established to cabin the agency’s authority and to prevent precisely what has happened here: a law enforcement agency lacking scientific and medical expertise dictating the outcomes of drug scheduling.”

The firm is proud to stand with Dr. Aggarwal and his efforts to make a promising and game-changing treatment available to ease the pain of patients nearing the end of their lives and others who may benefit from such therapies. The federal government’s imperviousness to scientific and medical evidence that does not align with their obsolete treatment of potentially beneficial drugs unjustly interferes with the doctor-patient relationship and deprives patients of much-needed relief.