Policy Considerations for Psychedelics in Research and Medicine – What’s Next on the Schedule?

Summary

Psychedelic compounds like psilocybin and MDMA are being researched for their potential in treating mental health conditions, with the FDA granting Breakthrough Therapy designations for some uses. Despite being classified as Schedule I substances, which limits their medical use, there are over 150 active clinical trials exploring their safety and efficacy. Recent federal initiatives aim to reform regulations to facilitate research and access to these drugs for serious mental illnesses.

Study at a glance

Abstract

There is growing interest in psychedelic compounds such as psilocybin, 3,4-metheylenedioxymethamphetamine (MDMA), lysergic acid diethylamide (LSD), and dimethyltryptamine (DMT) given emerging research on potential uses as treatments for a variety of health conditions. The United States Food and Drug Administration (FDA) has granted multiple “Breakthrough Therapy” designations to various psychedelic drugs used as treatments for mental health conditions, including MDMA-assisted therapy for posttraumatic stress disorder, psilocybin and 5-MeO-DMT for treatment-resistant depression, and LSD for generalized anxiety disorder. However, most psychedelics remain classified as Schedule I under the US Controlled Substances Act (CSA) and are not yet FDA approved for medical use. The Schedule I classification is intended for substances with no accepted medical use and a high potential for abuse, and it carries the strictest federal regulations related to supply, access, distribution, and storage. Nonetheless, there is a growing body of evidence on the neurobiological mechanisms and therapeutic potential of Schedule I psychedelics and over 150 active clinical trials assessing the safety and efficacy of using psychedelics as treatments for various health conditions. There is also growing support from federal research agencies interested in potential medical applications of psychedelics, along with bipartisan activities in Congress and a wide variety of state- and local-level policy reforms. In addition, a recent Executive Order called for federal reforms to accelerate research and access to psychedelic drugs used in treatments for serious mental illness, including timely rescheduling by initiating reviews of relevant products upon successful completion of Phase 3 clinical trials. Rescheduling at the federal level could reduce costs and administrative barriers for legitimate uses of psychedelic drugs in research and medicine while maintaining necessary regulations to ensure safety and accountability of supply and access. This article outlines potential paths for rescheduling various Schedule I psychedelics given the emerging clinical applications.

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