The Food and Drug Administration will open a public hearing Monday afternoon on how psychedelic drugs should be delivered to patients. It has not approved a single one.

The hearing runs from 12:30 to 4:30 p.m. Eastern at the agency’s White Oak campus in Silver Spring, with a virtual option. Four topics are on the agenda: provider training and credentialing, patient safety, access, and data collection. Those are the questions a regulator works through after a drug clears approval, not before.

The notice announcing the hearing is explicit about what it will not discuss. FDA said it “is not seeking comment on” the safety or effectiveness of any particular drug product, the scheduling status of any substance, or “the legalization or decriminalization of psychedelic substances.” Comments on those subjects, the agency wrote, “may not be considered.”

The hearing implements Executive Order 14401, signed April 18, which establishes a federal policy of “accelerating innovative research models and appropriate drug approvals” to expand access to psychedelics for serious mental illness. In April the agency issued national priority vouchers, which compress review timelines, to companies studying psilocybin for treatment-resistant depression, psilocybin for major depression, and methylone for PTSD.

FDA notes in the same document that a voucher is not a finding of safety or effectiveness, and neither is breakthrough therapy designation—neither substitutes for approval.

The last psychedelic to reach that stage did not clear it. In 2024 the agency’s Psychopharmacologic Drugs Advisory Committee voted 10 to 1 that the benefits of Lykos Therapeutics’ MDMA-assisted therapy for PTSD did not outweigh its risks, and 9 to 2 that the company had not shown effectiveness. Members raised selection bias and functional unblinding, the problem that patients can tell whether they received the drug. FDA followed with a complete response letter saying the application “could not be approved based on data submitted to date” and asked for another Phase 3 trial.

Meanwhile, the drugs are already circulating. Researchers at the University of Virginia School of Medicine found 4,055 psilocybin exposures among Americans ages 13 to 25 reported to U.S. poison centers between 2013 and 2022. Cases were flat through 2018, then began climbing in 2019. By 202,2 they had more than tripled among adolescents and more than doubled among young adults. About three in four cases required medical attention.

A transcript will be posted to the docket after the hearing. Written comments are open until October 5.

The agency is about to spend four hours on how it would build the delivery system. It has not said what, if anything, it will be delivering.

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