Development and Regulation of Psychedelics for Therapeutic Use

Workshop Description

In recent years, there has been a resurgence in the investigation of psychedelic drugs to treat various conditions in clinical settings. This renewed interest in the therapeutic applications has led to the exploration of psychedelics for treating conditions such as major depressive disorder (MDD), anxiety, post-traumatic stress disorder (PTSD), and substance use disorders among others. However, the Schedule I categorization of many of these substances has complicated their use in clinical settings. Additionally, significant challenges exist in both clinical trial design and conduct when studying psychedelic therapeutics, hampering progress on finding promising clinical applications.

The Robert J. Margolis, MD, Center for Health Policy at Duke University, under a cooperative agreement with the U.S. Food and Drug Administration (FDA), held a private meeting on April 12 and 13, 2021 that brought together a range of stakeholders to discuss the development and regulation of psychedelics for therapeutic use. In this meeting, participants identified specific challenges associated with clinical trials investigating the therapeutic use of psychedelics and discussed emerging best practices for the development and regulation of these drugs.

Funding Acknowledgement

This event was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $4,241,714 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.