On September 14, 2026, FDA convened a Part 15 hearing to discuss “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs.” The meeting was a compilation of 2 minute segments for 80 public commentators representing a diverse community of academia, patients, advocates, service providers, and industry. The listening panel included members of FDA and federal partners such as the Veterans Health Administration and the Substance Abuse and Mental Health Services Administration.
The meeting focused on feedback for 4 key areas:
- Provider training and credentialing
- Promotion of patient safety
- Considerations for access
- Best practices for data collection and standardization
The 4-hour meeting generated many ideas and recommendations for Agency consideration. The five general themes summarized below provide a high-level synthesis while recognizing the equal importance of the other perspectives shared:
Standardized, competency-based training should support the full treatment process
Psychedelic treatment is a process, not a single event. The patient experience is critical to treatment durability and outcomes and extends beyond drug administration and a few hours of onsite monitoring. Everyone involved in the process should demonstrate proficiency in core competencies related to preparation, administration, and follow-up. Variability in training may affect both real-world evidence and patient outcomes.
Define clear roles and responsibilities across the full healthcare team
Infrastructure and design of post-marketing activities should reflect the full range of healthcare professionals involved in the treatment process, not only prescribers. Clearly defined roles and responsibilities should account for nurses, facilitators, pharmacists, and other trained professionals who support patients throughout psychedelic treatment.
Planning and infrastructure should anticipate and scale for future indications
Psychedelic research is evolving rapidly beyond mental health to include areas such as brain injury, women’s health, addiction and substance abuse, pain management and oncology. Planning and infrastructure for late-phase products should anticipate potential new indications and be designed to scale as their use expands.
Build on existing experience, expertise, and continuous learning
Experience from Oregon, Colorado, and Australia, along with established competencies in addiction treatment and lessons from cannabinoid implementation, can provide valuable reference points. A broad community of experts is ready and willing to support the design and execution of the next phases of psychedelic rollout. Because initial implementation is only the beginning, a continuous feedback loop will be essential to monitor outcomes, adapt requirements, and respond to developments such as the potential availability of non-hallucinogenic psychedelics.
Address regulatory, reimbursement, evidence, and stigma-related barriers to meaningful patient access
Key considerations include the potential need for a Risk Evaluation and Mitigation Strategy (REMS), reimbursement challenges, persistent stigma surrounding psychedelics, and fit-for-purpose data collection to support evidence generation. Establishing an approved pathway is essential, but approval alone will not ensure meaningful patient access.
The meeting also surfaced many additional perspectives. The hearing followed the release of two relevant publications the prior week: 1) FDA’s New Framework for Psychedelic Drugs1 and 2) Psilocybin2. Together, these and other developments reflect strong and growing interest in advancing psychedelic therapies to address unmet patient needs across a range of indications.
If you have not contributed already, written comments to the public docket Federal Register: Considerations for Potential Future Therapeutic Use of Psychedelic Drugs; Public Hearing; Request for Comments are due by 11:59 p.m. ET on October 5, 2026.
This summary reflects general themes from the public commentary; individual statements and comments are not cited or attributed to specific speakers. Refer to the formal docket for the complete comments and the agenda for speaker attribution.
References
1 Davis M, Farchione TR, Fischer BA, Buracchio T. FDA’s New Framework for Psychedelic Drugs. N Engl J Med. 2026;395(10):1027-1028
2 Rosenblat JD, Husain MI. Psilocybin. JAMA. Published online September 10, 2026. doi:10.1001/jama.2026.11874
About UBC
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. UBC leads the market in providing integrated, comprehensive clinical, safety, and commercialization services and is uniquely positioned to seamlessly integrate best-in-class services throughout the lifecycle of a product.
About the Author
Rachel Bonfanti, Executive Director, Risk Management & Scientific Consulting
Rachel Bonfanti, MPH, is a risk management and patient safety professional with over 16 years of experience in risk management, Risk Evaluation and Mitigation Strategies (REMS), and postmarketing safety across multiple therapeutic areas. She currently serves as Executive Director of Risk Management & Scientific Consulting at UBC, where she oversees risk management and REMS strategy. In this role she is responsible for translating complex safety requirements into effective, patient‑centered programs ensuring product benefits outweigh risks. Her work has included the design, implementation, and/or evaluation of more than 50 REMS.
