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

Psychedelic compounds like psilocybin, MDMA, LSD, and DMT show promise for treating mental health conditions, with the FDA granting Breakthrough Therapy designations for several uses. Despite this, most remain Schedule I under the Controlled Substances Act, indicating no accepted medical use and high abuse potential, which imposes strict regulations. Over 150 active clinical trials are assessing their safety and efficacy, and federal research agencies, bipartisan congressional activities, and state-level reforms support their medical applications. A recent Executive Order calls for federal reforms to accelerate research and access, including timely rescheduling after Phase 3 trials. Rescheduling could reduce costs and administrative barriers while maintaining safety. The article outlines potential paths for rescheduling various Schedule I psychedelics given emerging clinical applications.

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.