Dr. Sunil Aggarwal, alongside the Advanced Integrative Medical Science Institute (AIMS) he helped establish, is challenging the Drug Enforcement Administration (DEA) in court. Their lawsuit arises from the DEA’s refusal to permit the use of psilocybin for treating patients facing the end stages of their lives, despite Washington state’s “Right-to-Try” law, which allows for the use of experimental drugs for therapeutic purposes.
In his legal submission, Dr. Aggarwal recounts multiple attempts to gain DEA approval for such treatments, all of which were rebuffed without consideration of his detailed arguments. Psilocybin, classified as a Schedule 1 substance under the Controlled Substances Act, is deemed to lack any medicinal benefits. Yet, the filing highlights the contradiction of this classification by noting that psilocybin has been designated as a “breakthrough therapy” by the Food and Drug Administration (FDA) and is currently in phase III clinical trials.
The lawsuit argues that if the DEA is to deny Dr. Aggarwal the ability to provide psilocybin under the Controlled Substances Act and the Right-to-Try law, it must offer a well-reasoned rationale that aligns with both the Act and its own precedents. Dr. Aggarwal, who holds a DEA license for prescribing drugs classified from Schedule II to V, had initially sought permission under the Right-to-Try laws without requiring a special waiver and was denied. Following this, he proposed using the drug under a special waiver, citing instances where the DEA had previously granted such exceptions, including for the therapeutic use of cannabis in children. Despite these precedents, his requests were denied.
Dr. Aggarwal’s practice involves treating patients with advanced-stage cancer, many of whom experience severe anxiety and depression unmitigated by approved treatments. He has considered psilocybin therapy as a potential treatment, discussing its potential benefits and risks with his patients, who have expressed interest and provided informed consent.
Kathryn L. Tucker, representing Dr. Aggarwal and AIMS and affiliated with the National Psychedelics Association, expressed frustration to Law360 about the DEA’s denials, highlighting the impediment these actions pose to terminally ill patients seeking relief from severe psychological distress.
The DEA’s stance, as outlined in 2022, suggests that allowing psilocybin access to terminally ill patients could pose risks to public health and safety. Furthermore, the DEA suggested Dr. Aggarwal register as a researcher to obtain psilocybin legally, a process that entails developing a study protocol for FDA approval, which Dr. Aggarwal argues contradicts the Right-to-Try law’s intent.
In related developments, a Ninth Circuit panel in October requested the DEA to provide a detailed explanation for its position on keeping psilocybin as a Schedule I drug, following a superficial dismissal of Dr. Aggarwal’s request to reclassify it under Schedule II, which includes drugs considered to have a legitimate medical use under strict regulation.