• The FDA's Sept. 14 public hearing on the potential future therapeutic use of psychedelic drugs marks one of the most significant regulatory moments for the field.
• The FDA is accepting written testimony to its docket, which remains open through October 5.
• MAPS is coordinating with key industry stakeholders to address systems readiness, therapist training, and patient access as clinical promise nears reality of FDA approval.
  

WASHINGTON, Sept. 17, 2026 (GLOBE NEWSWIRE) -- The FDA's September 14 hearing marked one of the most consequential regulatory moments for psychedelic-assisted therapy to date. The Multidisciplinary Association for Psychedelic Studies (MAPS) attended, and plans to submit formal, written testimony to the FDA's public docket on systems readiness, therapist training, and patient access.

MAPS also shared its recently-published, open-science Ibogaine Investigator's Brochure with federal health officials — including the U.S. Department of Health and Human Services, the Food and Drug Administration, and the Department of Veterans Affairs — as part of its broader effort to ground federal psychedelic policy in current safety and sourcing data, rather than decades-old research.

The hearing followed the FDA publishing a recent final guidance for clinical investigations of psychedelic drugs, which clarified expectations for trial design, blinding, and long-term safety follow-up. The guidance was a meaningful step toward regulatory coherence, but it left open deeper infrastructure questions, like: how to build a trained and supported clinical workforce, the challenges of setting clear standards for informed consent across substances, and the establishment of insurance frameworks that don't limit access to those who can pay out of pocket. Speakers at the hearing touched on a number of these and other complex questions, demonstrating a notable maturation of the discourse across the field.

"The importance of therapy to these treatments cannot be understated — and it wasn't. Nearly every speaker mentioned it. The FDA heard loud and clear that the field supports therapy and therapist training; now it's up to them to listen. Yet an approved pathway isn't the same as an accessible one. Even with FDA approval, most of the people who need this treatment could be waiting for years due to systemic issues like lack of insurance coverage, knowledge gaps among providers, and limited availability of trained practitioners. State-regulated and community-based systems can fill part of that gap, but only with real training, clear boundaries of practice, and deep community involvement. Care doesn't end when a treatment does. Integration and post-treatment support must be built into communities because regulation isn’t what heals us or keeps us safe — we do that in community."
—Betty Aldworth; Co-Executive Director, MAPS

"Breakthrough clinical findings are promising, but mean little if the systems around them are not prepared to deliver them to patients. We continue to celebrate positive data published by academic centers, nonprofits, and industry alike, but stakeholders from each of these sectors will have to collaborate to build the licensing pathways, establish the insurance codes, and resource the community health infrastructure that determines who actually gets access (and who benefits over time) once a therapy is approved by the FDA. Our commitment to collaboration across the field is grounded in the belief that it is necessary to see the population-level benefits that we believe are possible. If that work doesn't happen now - and together - it will be the most vulnerable populations who will once again be left behind."
—Ismail Ali, J.D.; Co-Executive Director, MAPS

Mental health care is already one of the hardest treatment categories to access — a reality that holds true even for people with excellent insurance. The gap widens further for people managing socioeconomic and logistical barriers, including the ability to afford treatments, take time off work, arrange child care, or navigate a system that assumes flexibility most people don't have.

MAPS is coordinating with qualified researchers, clinicians, and advocates to prepare written testimony addressing systems readiness, therapist training capacity, and patient access. The organization encourages other stakeholders to submit written comments to the FDA's docket here before the Oct. 5 deadline.

ABOUT MAPS
Founded in 1986, MAPS is a 501(c)(3) nonprofit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful use of psychedelics and marijuana. MAPS previously sponsored the most advanced psychedelic-assisted therapy research in the world and continues to support psychedelic and marijuana research with a focus on the people and places most impacted by trauma. MAPS incubated Resilient Pharmaceuticals (formerly Lykos Therapeutics and the MAPS Public Benefit Corporation) and The Zendo Project, a leader in psychedelic harm reduction. Since MAPS was founded, philanthropic donors and grantors have given more than $150 million to advance psychedelic research, change drug policy, and shape culture.

Media Contact:
media@maps.org