A Review of the Food and Drug Administration Pipeline and Proposed California Legislation on Medicinal Psychedelics.
Jack R Watson, Laura E. Halpin, Violeta Barroso, George Dahdouh, Jacqueline Bursalyan, Saahil Mohta, Michelle Flores, Natalie A Gonzalez, John Gordineer, Germain Medina, Crystal Oseguera, Jailene Lazaro Serrano
The Permanente Journal March 14, 2025 DOI: 10.7812/TPP/24.171 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Keywords | FDA Pipeline Medicinal psychedelics Psychedelic treatment Hallucinogenic therapy Regulatory compliance Drug policy Behavioral health Psychological therapy California legislation state |
| Citations | 2 |
| Key findings | The FDA remains the appropriate agency to evaluate and approve psychedelic therapeutics, as legislative alternatives may not ensure thorough drug safety evaluation. |
Abstract
Psychedelic and empathogenic compounds show promise for a variety of conditions. However, studying these compounds can be highly complex, be very expensive, and have substantial patient safety concerns. Here, the authors will review 8 late-phase medicinal psychedelic studies in the Food and Drug Adminisration (FDA) approval pipeline. The authors will include a review of the FDA's recent denial of the New Drug Application for 3-4-methylenedioxymethamphetamine with adjuvant psychotherapy for posttraumatic stress disorder from Lykos Therapeutics of San Jose, California (formerly the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation). Additionally, the authors will discuss the parallel legislative proposals in California to legalize psychedelic compounds for adult use. These legislative efforts reflect an alternative and less expensive pathway, but they do not make as thorough of an evaluation for drug safety. The authors will propose that the FDA remains the appropriate agency to evaluate and approve the use of this class of proposed therapeutics.