In an unprecedented move, the U.S. Food and Drug Administration (FDA) has released guidance for researchers developing novel medicines, a step that has been applauded by the chairs of the Congressional Psychedelics Caucus. This marks a significant shift in the federal agency’s approach to the study of psychedelic substances, which have long been stigmatized and heavily regulated. The FDA’s guidance document, titled “Developing Drugs Containing Psychedelics,” provides a comprehensive roadmap for researchers interested in exploring the potential therapeutic benefits of these substances. The document outlines the necessary steps for preclinical and clinical development, including safety assessments, study design, and data collection. The co-chairs of the Congressional Psychedelics Caucus, Reps. Alexandria Ocasio-Cortez (D-NY) and Earl Blumenauer (D-OR), have lauded the FDA’s move. They believe this is a significant step towards the destigmatization of psychedelics and the recognition of their potential therapeutic value. The FDA’s new guidance comes at a time when there is a growing interest in the potential therapeutic applications of psychedelics. A number of startups in Silicon Valley and beyond are already exploring the use of substances like psilocybin (found in magic mushrooms) and MDMA (commonly known as ecstasy) for the treatment of mental health conditions such as depression, anxiety, and post-traumatic stress disorder (PTSD). This development is a clear indication of the shifting attitudes toward psychedelics in the medical and scientific community. It also underscores the importance of rigorous, evidence-based research in unlocking the potential of these substances to transform mental health treatment. However, it’s important to note that while the FDA’s guidance is a significant step forward, it doesn’t change the legal status of these substances. Psychedelics remain classified as Schedule I drugs under the Controlled Substances Act, meaning they are still illegal under federal law. The journey toward the acceptance and legalization of these substances for therapeutic use is far from over, but this move by the FDA certainly marks a pivotal moment in that journey.
By John Biggs
John Biggs is an entrepreneur, consultant, writer, and maker. He spent fifteen years as an editor for Gizmodo, CrunchGear, and TechCrunch and has a deep background in hardware startups, 3D printing, and blockchain. His work has appeared in Men’s Health, Wired, and the New York Times.
