FDA holds a public hearing on how approved psychedelic drugs could be used

What happened

FDA held the hearing under 21 CFR part 15 on September 14, 2026, from 12:30 to 4:30 p.m. Eastern Time, in person at its White Oak campus and online. It was announced in the Federal Register on July 14 (91 FR 43095, Docket No. FDA-2026-N-7542).¹² The agenda and event page are on FDA's site.³

FDA asked for public input on four topics: "(1) provider training and credentialing, (2) promotion of patient safety, (3) considerations for access, and (4) best practices for data collection and standardization".² Under patient safety, it asked about screening patients before treatment for conditions linked to worse outcomes, naming "cardiovascular disease, psychosis, or suicidality".²

Under data collection, the notice asked about "common data elements across data sources for drug, dosage, indication, setting, and patient characteristics", and about how to define, identify and report adverse events. It listed state programs for psychedelic use among the data sources.²

The executive order behind it

The notice ties the hearing to Executive Order 14401 of April 18, 2026, "Accelerating Medical Treatments for Serious Mental Illness" (91 FR 21709).² The order:⁴

• directs FDA to give Commissioner's National Priority Vouchers to appropriate psychedelic drugs with Breakthrough Therapy designation;
• directs FDA and DEA to set up a pathway for eligible patients under the Right to Try Act;
• directs HHS, through ARPA-H, to allocate "at least $50 million from existing funds" to partner with states that have or are developing psychedelic programs;
• directs the Attorney General to review any product with a Schedule I substance that completes Phase 3 trials for a serious mental health disorder, so rescheduling, if appropriate, can follow approval quickly.

A companion request for information from HRSA on training and care delivery models (91 FR 43103) closed on August 13, 2026.⁵

What speakers raised

FDA's agenda listed 80 public commenters, in person and online, with two minutes each.³ Psychiatric Times reported that the widest disagreement was over who should administer treatment: calls for mandatory psychiatrist oversight against the case for nurse-led care, and whether credentialing should follow the evidence each sponsor supports in its labeling. It also reported a proposal for a standard way to classify adverse events, and a call from a speaker formerly of FDA's drug center against one template risk management program (a REMS) for the whole class, because compounds differ.¹⁰ We have not reviewed the transcript.

Why it matters if you read dose claims

The data question is the gap this site keeps returning to. Online calculators produce a number without knowing what's in the mushrooms or who's taking them. In our audit of 36 online calculators, 11 stated the potency they assume and 5 cited research. FDA is now asking how clinics, surveys and state programs should record the drug, the dosage, the setting and the person in the same format, so results can be compared.

Trials already screen for conditions like these. The protocol for Compass Pathways' COMP001 trial, for example, excluded people with a current or past psychotic disorder, suicidal behavior in the past year, blood pressure above 140/90 mmHg, or a stroke or heart attack within the past year.⁶ Our page on who should avoid psilocybin lists those conditions and the trials behind them. For FDA's rules for the trials themselves, see our report on its final guidance.