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2024 FDLI Update 23 (2024)
FDA Law and the Psychedelic Renaissance

handle is hein.journals/fdliup2024 and id is 25 raw text is: FDA Law and the Psychedelic Renaissance by Edgar J. Asebey & James T O'Reilly* On December 11, 2023, the U.S. Food and Drug Adminis- tration (FDA) received the first ever New Drug Application (NDA)l for a psychedelic-assisted therapy.2 The application was filed by the Multidisciplinary Association for Psyche- delic Studies (MAPS) Public Benefit Corporation (PBC) for MDMA-assisted therapy for Post-Traumatic Stress Disorder (PTSD) and represents the culmination of over a decade of clinical trials by the organization. On February 9, 2024, MAPS-PBC, now known as Lykos Therapeutics, announced that FDA had accepted its NDA, granted the application pri- ority review, and assigned a PDUFA3 target date of August 11, 2024. If approved, this would be the first ever FDA-ap- proved psychedelic therapy. In light of a potential impending FDA approval, as well as a proliferation of clinical studies using psychedelic substances, in 2024 it is essential to understand the history of what some indigenous cultures consider sacred medi- cines4 and what FDA has, in two cases,5 recently classified as breakthrough therapies6 for certain mental health diseases. In this article we briefly review the history of psychedelics' discovery and traditional use, psychedelics as breakthrough therapies, the policy debate of decriminalization vs. FDA ap- proval of psychedelic therapeutics, as well as the regulatory and policy challenges that lie ahead. A Brief History In 1943, Albert Hofmann, a Swiss chemist working at San- doz, discovered the psychedelic properties of lysergic acid diethylamide (LSD), but it was not until the late 1950s that LSD started to be investigated for use in psychiatry, alcohol Edgar J. Asebey is partner at Keller Asebey Life Science Law PLLC and a life sciences attorney with over 20 years of experience advising clients in the medical device, pharmaceutical, biotechnology, food, dietary supplement, cannabis, and psychedelic biotech industries on FDA and state regulatory compliance, transactions, importation, licensing, and venture finance matters. He is also the co-author of the Legal Guide to the Business of Marijuana: Cannabis, Hemp and CBD Regulation (PLI Press, 2023). James T. O'Reilly is a professor at the University of Cincinnati College of Medicine and College of Law, where he has taught courses in Public Health Policy and Food, Drug, and Safety Laws for 39 years. He has authored over 50 textbooks, including COVID-19 and Other Pandemics: Business and Legal Challenges and Healthcare Employment Practice: Policy, Law and Procedure. He is also the co-author of the Legal Guide to the Business of Marijuana: Cannabis, Hemp and CBD Regulation (PLI Press, 2023). Spring2024 UPDATE FDLT