Psychedelic Drugs in the Post-Approval World: Important Components of Risk Evaluation and Mitigations Strategy (REMS) Programs to Protect Public Health while Ensuring Widespread Access

Coe M, Ashworth J, Schnoll S, Henningfield J.

Under the Food and Drug Administration Amendments Act of 2007, the FDA can require the use of risk evaluation and mitigation strategies (REMS) over and above professional labeling, to ensure that a drug’s benefits outweigh its risks. As of August 2021, there were 314 listings on for interventional trials administering psychedelic/hallucinogenic compounds. Psychedelic drugs (e.g., MDMA, psilocybin, LSD, DMT, mescaline) are in development for myriad indications, including treatment of cluster headache, pain, substance use disorders, PTSD, and many other debilitating diseases. This unique group of drugs has demonstrated significant efficacy in many of these indications; yet, there are challenges inherent to their widespread use, including the psychedelic experience (which often includes auditory and visual hallucination, extreme emotional volatility), long-lasting acute drug effects, and questions about the durability of effect. These potential harms may be measured using a REMS post-approval to ensure a positive benefit/risk ratio.

Presented at the American College of Neuropsychopharmacology 60th Annual Meeting, December 5–8, 2021.