FDA holds hearing on regulatory future of psychedelic therapies

The FDA recently held a public hearing regarding the potential therapeutic use of psychedelic drugs, marking a significant regulatory milestone for the field. The Multidisciplinary Association for Psychedelic Studies (MAPS) attended the hearing and intends to submit formal testimony addressing systems readiness, therapist training, and patient access.

As clinical development progresses, questions are emerging regarding the safe integration of these medicines into the healthcare system. While phase 3 trials for MDMA-assisted therapy for PTSD and synthetic psilocybin for treatment-resistant depression have shown efficacy, the FDA has requested additional studies or is currently reviewing new drug applications.

Industry investment is increasing, highlighted by Eli Lilly and Company’s July 2026 agreement to acquire AtaiBeckley, the developer of the intranasal formulation BPL-003. These developments highlight the need for infrastructure, including a trained clinical workforce, informed consent standards, and insurance frameworks to ensure access.