DEA Faces Legal Challenge Over Denial Of Psilocybin For End-Of-Life Care

A federal appeals court heard arguments on Monday in a case that could significantly impact access to psilocybin for terminally ill patients. As reported by Marijuana Moment, the case brought by Dr. Sunil Aggarwal and his Advanced Integrated Medical Science (AIMS) Institute, challenges the Drug Enforcement Administration’s (DEA) decision to deny the use of psilocybin under state and federal Right to Try (RTT) laws. These laws aim to provide patients with terminal conditions the opportunity to try investigational drugs that have yet to receive full approval.

Dr. Aggarwal, who has been advocating for the therapeutic use of psilocybin for patients in end-of-life care since at least 2020, argues that RTT laws should permit the use of psilocybin, despite its classification as a Schedule I controlled substance. However, the DEA maintains that RTT laws do not exempt any substance from the restrictions imposed by the Controlled Substances Act (CSA).

Legal Dispute Over Right To Try And Controlled Substances

During the hearing before the Ninth Circuit Court of Appeals, Shane Pennington, an attorney for Dr. Aggarwal, argued that the DEA’s interpretation of the RTT laws is overly restrictive. "What we're faced with is a categorical view of the world from the DEA, and that categorical view of the world is that there is no path to access Schedule I substances for therapeutic use," Pennington said. He emphasized that the RTT laws clearly define what constitutes an “eligible investigational drug,” and psilocybin fits within that definition.

The case is rooted in a series of legal and administrative challenges initiated by Dr. Aggarwal. After the DEA initially rejected his request to access psilocybin for palliative care patients, Aggarwal sued the agency. Although a previous lawsuit was dismissed due to jurisdictional issues, Aggarwal’s legal team refiled the case after the DEA denied a formal petition to reschedule psilocybin and a subsequent regulatory waiver request in 2022.

DEA's Position And Judicial Scrutiny

The DEA's stance is that RTT laws do not grant it the authority to waive CSA requirements for Schedule I substances like psilocybin. "The agency first noted the features of the substance in question, which is that it has no currently accepted medical use, high potential for abuse and a lack of accepted safety," DEA attorney Thomas Pulham explained during the hearing.

However, the judges expressed skepticism over the DEA’s reasoning, questioning whether the agency had fully explored its ability to accommodate Aggarwal’s request. Judge Marsha Berzon said the DEA had the authority to create exceptions or issue waivers but failed to justify why it did not do so in this case.

Implications For Psilocybin In Palliative Care

Dr. Aggarwal's legal battle is part of a broader movement to re-evaluate the medical potential of psilocybin, particularly in palliative care. Psilocybin has been designated as a “breakthrough therapy” by the Food and Drug Administration (FDA) for its potential to treat various mental health conditions, including anxiety and depression in terminally ill patients. Despite its Schedule I classification, which denotes a substance with no accepted medical use, there is growing evidence to suggest that psilocybin could provide significant therapeutic benefits.

Washington State and eight other jurisdictions have supported Aggarwal's position, arguing in an amicus brief that the CSA does not prevent the use of controlled substances under RTT laws. "The RTT Act's purpose is to provide a unique, targeted exemption from such requirements," the brief states, emphasizing that RTT laws are intended to give terminally ill patients access to potentially life-saving treatments.

Ongoing Research And Future Outlook

As the legal proceedings continue, research into the medical uses of psilocybin is expanding. Studies have shown promising results in using psilocybin to treat conditions such as depression, anxiety and substance misuse. Notably, recent findings suggest that psilocybin may offer more profound effects when used in its natural, full-spectrum form, as opposed to synthetic versions.

The outcome of Dr. Aggarwal's case could have far-reaching implications not only for his patients but also for the future of psychedelic-assisted therapy in the U.S. If the court rules in favor of allowing psilocybin under RTT laws, it could pave the way for broader access to this and other Schedule I substances for therapeutic use.

Cover image made with AI