FDA Holds Landmark Public Hearing On The Future Therapeutic Use Of Psychedelic Drugs

Key Takeaways:

• This hearing signals that FDA and collaborating federal partners are actively considering how to shape the regulatory environment for both drug approval and clinical delivery, including who may administer psychedelic-assisted therapies and under what conditions.
• The hearing supports implementation of Executive Order 14401, which directs federal agencies to expedite research, review, and approval of psychedelic drugs for serious mental health conditions.
• The scope of the hearing did not include FDA’s consideration of input on individual drug applications, the scheduling of controlled substances, or the legalization or decriminalization of psychedelics.
• Written public comments are due by October 5, 2026. Lifesciences companies, healthcare systems, providers, and other stakeholders should consider submitting comments to FDA. 

On September 14, 2026, the U.S. Food and Drug Administration (FDA), held in collaboration with federal partners including the Veterans Health Administration (VHA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Advanced Research Projects Agency for Health (ARPA-H), and the National Institute on Drug Abuse (NIDA) held a Part 15 public hearing entitled “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs.” The hybrid hearing ran from 12:30 p.m. to 4:30 p.m. ET and drew over 18,000 registered attendees, with approximately 80 speakers selected from more than 200 requests to present.

The hearing comes at a pivotal moment for psychedelic drug development in the United States. It represents one of the earliest implementations of Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illness,” issued by the Trump administration on April 18, 2026, which directs federal agencies to expedite the research, review, and approval of psychedelic drugs for serious mental health conditions. In April 2026, FDA issued national priority vouchers to three companies studying psilocybin for treatment-resistant depression (TRD), psilocybin for major depressive disorder (MDD), and methylone for post-traumatic stress disorder (PTSD). FDA has previously granted Breakthrough Therapy designation to specific psychedelic drug programs, including MDMA for PTSD and psilocybin for TRD and MDD. In July 2026, FDA finalized its guidance, “Psychedelic Drugs: Considerations for Clinical Investigations,” providing recommendations to sponsors on clinical trial design for this drug class.

Key Themes from Public Comments

The hearing was organized around four principal discussion topics: (1) provider training and credentialing; (2) promotion of patient safety; (3) considerations for access; and (4) best practices for data collection and standardization. Speakers presented to a federal partner listening panel which consisted of six individuals from FDA and collaborating federal partners.

Provider Training and Credentialing. A dominant theme across the hearing was the urgent need for standardized, competency-based training and credentialing frameworks for providers involved in psychedelic-assisted therapy (PAT). Speakers called for accredited training programs that cover the entire episode of care—from patient screening through drug administration and post-session integration—rather than focusing on any single phase. Commenters emphasized that training should be competency-based, not discipline-specific, and should incorporate experiential and simulation-based methodologies. Multiple speakers noted that training should extend beyond administering providers to include referring providers and the broader healthcare workforce. Speakers also highlighted the importance of training on power dynamics, physical touch protocols, and informed consent.

Patient Safety. Commenters underscored that patient safety in PAT extends well beyond the pharmacological intervention itself. Several speakers urged FDA to set a safety floor rather than mandating a single clinical standard. At least one commentor recommended FDA consider REMS (Risk Evaluation and Mitigation Strategies) requirements that are proportionate and not overly prescriptive. Moving veteran testimony was provided, including from a combat veteran with PTSD who welcomed the therapeutic model but cautioned against over-regulation.

Access and Reimbursement. Access was cited as a critical concern across multiple dimensions. On the financial side, speakers stressed that without insurance coverage and adequate reimbursement frameworks, PAT will remain inaccessible to most patients—with one commenter characterizing reimbursement as “a safety question” because clinics will shut down without it. On the workforce side, commenters pointed to provider shortages in rural and underserved areas and urged that otherwise qualified clinicians be permitted to provide services consistent with their scope of practice and experience. Multiple speakers called for regulatory structures that allow certified administration to occur safely outside of hospitals and beyond purely psychiatric settings. Telehealth was recommended as an available but non-exclusive option for screening and follow-up.

Data Collection and Standardization. Speakers broadly agreed on the need for better, more consistent data collection practices—including real-world data, not just clinical trial data—captured at every stage of the patient care process. Some commenters recommended the use of a shared and common data language across treatments and providers. A particular focus was placed on standardizing what should be tracked: what was administered, its actual potency, its chemical profile, and how those variables relate to patient outcomes. Several speakers emphasized the need for women-specific data. AI-based solutions for developing real-world standards and data collection were also discussed.

Additional Noteworthy Considerations

• Indigenous communities: Commenters urged the involvement of indigenous populations in rulemaking, acknowledging both the indigenous origins of psychedelic use and the need for culturally appropriate frameworks.
• State-federal coordination: At least one speaker emphasized that state licensing and federal regulation should work in concert rather than operate on separate tracks.

Written Public Comments

FDA encourages stakeholders to submit written comments addressing the same four topics at issue during the hearing: (1) provider training and credentialing; (2) promotion of patient safety; (3) considerations for access; and (4) best practices for data collection and standardization. The public comment period closes on October 5, 2026.

The hearing signals that FDA, in conjunction with other federal agencies, is actively considering how to shape the regulatory environment not only for drug approval but also for the clinical delivery framework, accounting for the personnel administering these therapies and treatment conditions. Lifesciences companies, healthcare systems, and providers should consider submitting a comment to FDA.