FDA Holds Key Hearing on Psychedelic Drug Therapeutic Use

The Food and Drug Administration (FDA) held a significant public hearing on September 14, 2026, regarding the potential future therapeutic use of psychedelic drugs. This event marks one of the most important regulatory moments for the field, as it aims to pave the way for the approval of these substances for medical use.

MAPS, the Multidisciplinary Association for Psychedelic Studies, attended the hearing and plans to submit formal, written testimony to the FDA's public docket. The organization is focusing on addressing systems readiness, therapist training, and patient access as the clinical promise of psychedelic drugs nears reality.

Following the hearing, the FDA published a final guidance for clinical investigations of psychedelic drugs, which clarified expectations for trial design, blinding, and long-term safety follow-up. However, the guidance left open several critical infrastructure questions, such as how to build a trained and supported clinical workforce, establish clear standards for informed consent, and create insurance frameworks that do not limit access to those who can pay out of pocket.

Betty Aldworth, Co-Executive Director of MAPS, emphasized the importance of therapy in these treatments. "The importance of therapy to these treatments cannot be understated. 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," she stated.

Ismail Ali, J.D., Co-Executive Director of MAPS, highlighted the need for collaboration across sectors to build the necessary infrastructure. "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," he said.

The hearing followed the FDA's recent publication of a final guidance for clinical investigations of psychedelic drugs. This guidance was a meaningful step toward regulatory coherence, but it left open deeper infrastructure questions. Speakers at the hearing touched on a number of these and other complex questions, demonstrating a notable maturation of the discourse across the field.

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 by October 5, 2026.

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. Since its inception, MAPS has given more than $150 million to advance psychedelic research, change drug policy, and shape culture.