FDA's Sept. 14 hearing: how approved psychedelics might reach patients

What was the hearing about?

The FDA used a formal public hearing, in person at its White Oak campus in Maryland and online, to gather views on the "potential future therapeutic use" of psychedelic drugs "in supervised and supportive settings." It ran from 12:30 to 4:30 p.m. Eastern on Sept. 14, and the docket, FDA-2026-N-7542, accepted written comments until Oct. 5, 2026.¹

The notice listed four topics:¹

• Provider training and credentialing, including minimum staffing while a patient is under the drug's effects and the role of non-prescribers such as licensed counselors and peer support specialists.
• Patient safety, including screening for conditions linked to worse outcomes (the notice names cardiovascular disease, psychosis and suicidality), informed consent, preventing diversion, and follow-up that connects to emergency and crisis services.
• Access, including insurance coverage, payment, clinic space and staffing, and telehealth for screening and follow-up.
• Data collection, including registries and common data standards for tracking safety in real-world use.

What did the FDA say it wasn't asking about?

The notice says the FDA was not seeking comment on the safety or effectiveness of any particular drug or pending application, on scheduling under the Controlled Substances Act, on "the legalization or decriminalization of psychedelic substances, or the merits of state or local programs," or on religious, ceremonial or personal use. It did welcome input on collecting data from state programs.¹ In other words, the hearing was about how a future prescription medicine might be given, not about changing the law on mushrooms.

Why is the FDA doing this now?

The notice says the FDA issued national priority vouchers in April 2026 to companies studying psilocybin for treatment-resistant depression, psilocybin for major depressive disorder and methylone for PTSD. The vouchers are meant to shorten review times, and the FDA notes that neither a voucher nor a Breakthrough Therapy designation is a finding that a drug is safe or effective.¹

The notice says the hearing also supports implementation of Executive Order 14401, signed April 18, 2026.¹ The order tells the FDA to give priority vouchers to qualifying psychedelic drugs with Breakthrough designation; tells the FDA and DEA to set up a Right to Try pathway for eligible patients, including any needed Schedule I handling authorizations; directs HHS, through ARPA-H, to put at least $50 million from existing funds toward partnering with states that "have enacted or are developing programs" for psychedelic drugs; and directs the Attorney General, consulting HHS, to review any Schedule I product that completes Phase 3 trials for a serious mental health disorder, so that rescheduling, if appropriate, can proceed quickly for products that are approved.²

What does it mean for Nevada?

Nothing in the hearing changes Nevada law. Psilocybin is on Nevada's Schedule I list, NAC 453.510,³ and the state has no psilocybin program. That matters for the $50 million: the order aims it at states with programs enacted or in development.² We haven't found any public record of Nevada seeking a share.

Some of the federal steps now under way echo requests Nevada's Legislature made in 2025. SJR 10 urged Congress and federal agencies to allow compassionate use of psychedelic investigational drugs under the Right to Try Act and to reschedule psilocybin and other compounds, starting with those that have Breakthrough designation.⁴ The resolution expressed the Legislature's view; it didn't change state law.

For now, the only way to receive psilocybin under medical supervision in Nevada is a clinical trial; our therapy and trials guide lists them. The guide to when psilocybin could be legal in Nevada sets out the federal and state steps in order. If someone is struggling right now, call or text 988, or see our help page.