The ongoing legal battle between a doctor and the U.S. Drug Enforcement Administration (DEA) over the use of psychedelics, specifically psilocybin, for medical purposes is intensifying. Recently, the DEA asked the Ninth Circuit Court of Appeals to prevent a physician from using psilocybin to treat depression in terminally ill cancer patients, as reported by Law360. This dispute hinges on the interpretation of federal and state “Right-to-Try” laws, which permit the use of investigational drugs that have not yet received regulatory approval for therapeutic use.
Dr. Sunil Aggarwal, who co-founded the Advanced Integrative Medical Science Institute (AIMS) in Seattle, a clinic focusing on psychedelics research and treatment, has been a staunch advocate for the application of the Right to Try Act. He argues that this act allows him to administer psilocybin to his patients. Despite his efforts, the DEA contends that the Right to Try Act, which amends the Federal Food, Drug, and Cosmetic Act (FDCA), does not alter the obligations set by the Controlled Substances Act (CSA) that still restricts such actions. According to the DEA, the CSA and FDCA operate under separate regulatory frameworks, each with its own set of requirements and limitations.
The DEA’s recent filing emphasized that the Right to Try Act does not modify any provision within the CSA, and thus, the restrictions remain effective. Dr. Aggarwal, having been involved in this legal dispute for several years, has cited clinical trials showing psilocybin’s effectiveness in treating major depression. He argues that terminally ill patients should have access to psilocybin under the Right to Try Act. However, the DEA has consistently denied his applications, arguing in a 2022 rejection that providing psilocybin to terminally ill patients would compromise public health and safety.
The situation escalated when Dr. Aggarwal was informed by the DEA that he would need to register as a researcher to obtain psilocybin, a requirement he claims is contrary to the law. This prompted him to challenge the DEA’s decisions at the Ninth Circuit on the basis that they are arbitrary and do not align with public health interests or established legal precedents. In February, he urged the court to require the DEA to justify its stance in alignment with the CSA and the agency’s previous decisions, pointing out that the DEA had previously granted waivers for the therapeutic use of other controlled substances, including cannabis for pediatric use.
The DEA has responded by arguing that Dr. Aggarwal has not provided sufficient evidence to back his claims and that it could not adequately assess his proposal due to the lack of specific details about the waiver he sought.
Psilocybin is still classified as a Schedule I drug, defined as substances with no accepted medical use in the United States. However, its potential has been recognized by the FDA, which has granted it “breakthrough therapy status” twice, and it is currently undergoing stage III clinical trials.
The timeline for when the appellate court might deliver a verdict remains uncertain. Meanwhile, in a related case, the Ninth Circuit has directed the DEA to explain its rationale for maintaining psilocybin as a Schedule I drug after rejecting Dr. Aggarwal’s petition to reclassify it to Schedule II, which includes drugs considered to have a medical use but with high potential for abuse.