In brief
- On September 14, the FDA held a public hearing regarding the future therapeutic use of psychedelics.
- Discussions centered on professional accreditation, patient safety, data standards, and equitable access.
- Several speakers urged that community governance and indigenous knowledge keepers be involved in shaping regulations.
- Written comments are being accepted until October 5, 2026.
On September 14, the U.S. FDA convened a public hearing at its White Oak campus in Maryland, titled “Considerations for the Potential Future Therapeutic Use of Psychedelic Drugs.” The event featured participation from federal partners, including ARPA-H and the HHS.
Four Key Themes
According to reporting by Lucid News, the interventions focused on the accreditation of professionals, patient safety, data standardization, and equitable access to these therapies.
Specific Voices
Laurel Kilgour, of the Psychedelic Bar Association, warned that Risk Evaluation and Mitigation Strategies (REMS) should not unnecessarily limit access to patient care. Greg Hutchinson, from the Australian firm Emyria, noted that his organization has conducted over 500 dosing sessions under strict clinical governance.
Jean C. Velez Rodriguez, of the PRISMA Institute in Puerto Rico, explained that 53% of participants in a local study reported having used psilocybin at some point, and that 3.2 million U.S. citizens in Puerto Rico are currently excluded from federal datasets. Lakesha Jenkins-Samuels, of the Kiona Foundation, argued that “community governance is safety infrastructure” and called for traditional custodians of these medicines to be present in the room where regulations are drafted.
From the government side, Matt Zorn, deputy chief counsel at the HHS, encouraged the formation of consortia that combine academics with traditional knowledge holders, while clarifying the expected pace: “We are not going to fund someone who isn’t going to move fast.”
Implications
The hearing does not approve anything or set regulations; it is a listening phase. Lucid frames the event within a tension between regulators building safety mechanisms and federal officials pushing for shorter timelines; the H.R. 10150 bill would grant 12 years of market exclusivity to approved botanical drugs. On September 9, an article in the New England Journal of Medicine, signed by four senior FDA officials, outlined the agency’s new framework for psychedelic drugs.
It is important to read these reports for what they are: summaries of stakeholder interventions, many from organizations with interests in the sector. How much weight each carries in the final decision will become clear once the comment period closes and the FDA publishes its next steps. Those seeking more context on the clinical approach can consult our guide on the science of psychedelic therapy and our guide on psilocybin. We previously reported on the announcement of the hearing, and this is the first summary of what was said in the room.
Source
- Jack Gorsline / Lucid News. FDA Holds Historic Public Hearing on Psychedelic Therapies. Lucid News, September 22, 2026.
Educational content written from a harm reduction perspective and with respect for individual freedom. It is not a substitute for advice from a healthcare professional and is not intended to encourage or condemn any drug use.
