Washington Doctor Vs. DEA For Lawful Use Of Psilocybin To Treat Terminally Ill Patients

A protracted legal battle led by Dr. Sunil Aggarwal and the Advanced Integrative Medical Science Institute (AIMS) against the Drug Enforcement Administration (DEA) for the latter's refusal to allow psilocybin treatment for terminally-ill patients has taken another turn.

Dr. Aggarwal's original request was to treat his patients at the end of their lives under Washington State's right-to-try (RTT) law, which enables the use of unapproved investigational drugs such as psilocybin.

Now, a new federal appeals court filing by Aggarwal's lawyers states that the DEA failed to explain a key decision when denying him access to the psychedelic and calls judges to reverse the decision and request the government to reconsider the matter.

Also Read: DEA Renews Effort To Place 2 Psychedelics In Strictest Drug Category

Awaiting Patients

Sunil Aggarwal's patients have advanced-stage cancer, some suffering from severe and debilitating anxiety and depression, and do not respond to FDA-approved therapies. He discussed utilizing psilocybin therapy with certain patients who expressed a desire to try the treatment and provided informed consent.

Representing attorney Kathryn Tucker told Law360 that the extended legal dispute due to DEA's refusals has obstructed dying patients' access to a drug their doctors believe would give them relief.

In the brief, Aggarwal says the federal agency called him to register as a researcher in order to obtain psilocybin for his patients which, as he explains, would have him create a study protocol and submit it to the FDA for approval, not only consuming time but also going against the RTT law.

The Claim

In the court brief, Aggarwal stated that he had asked the DEA multiple times to allow him to treat his patients but was denied and that the DEA "has never addressed the arguments that Dr. Aggarwal has raised in support of them."

The document notes that Aggarwal first argued for the use of the drug under RTT laws without a special permit, and then with a special waiver, which the agency had reportedly granted in other instances such as for therapeutic cannabis for children. 

Although still a Schedule I substance under the Controlled Substances Act (CSA) and therefore federally illegal and considered to have no therapeutic qualities, the court brief highlights the fact that psilocybin has twice obtained "breakthrough therapy" status from the Food and Drug Administration (FDA) and is also in the final clinical trials stage.

"If DEA wants to disclaim authority to grant Dr. Aggarwal access to psilocybin under the CSA and RTT, it must provide a reasoned explanation for how that decision comports with the CSA and the agency's own precedent," according to the brief.

In a related case also involving Dr. Aggarwal and the DEA, a Ninth Circuit panel ordered the agency to clarify why it believes psilocybin should remain a Schedule I substance after it rejected Aggarwal's petition to move it to Schedule II, which would have enabled the doctor to use it as it involves a currently accepted medical use although with restrictions.

The court issued a ruling in Aggarwal's favor in October 2023 though it later denied the doctor's request to send the rescheduling petition to the FDA instead, as noted by Marijuana Moment.

"For the same reasons this Court remanded DEA's inadequate denial letter in Aggarwal less than four months ago, it must remand DEA's Final Decision in this case as well," the brief's argument summary reads.

AIMS’ lawyers have stated that the court "should grant the petition for review, declare DEA's Final Decision unlawful, set it aside, and remand this matter to the agency with instructions either to grant Dr. Aggarwal's Petition or provide the reasoned explanation for denying it" as the law requires.

The DEA’s deadline to respond is April 8; a reply from Aggarwal's lawyers is due by the end of May.

Photo: Benzinga edit with photos by Flametric, aiyoshi597, Gisele Yashar, Bacsica and Freedomz on Shutterstock.