Nearly Every Speaker at FDA’s Psychedelics Hearing Asked for Faster Access. Two Did Not.
The FDA held a public hearing on psychedelic therapy Monday. Of roughly 75 speakers, one argued the push for approval…
The FDA held a public hearing on psychedelic therapy Monday. Of roughly 75 speakers, one argued the push for approval is outrunning the science. The speaker right after him described losing her 21-year-old daughter following psychedelic use.
More than 1,800 people registered for the hearing at the agency’s White Oak campus, part of the federal effort launched by Executive Order 14401 in April, which directs agencies to accelerate approvals and expand access to psychedelics for serious mental illness. FDA officials said they were there “to listen.”
They had also said, in the notice announcing the hearing, what they would not listen to. The agency wrote that it “is not seeking comment on” the safety or effectiveness of any particular drug product, on scheduling, or on “the legalization or decriminalization of psychedelic substances.” Comments on those topics “may not be considered.”
Most of what the panel heard Monday was a call to widen the gate: more types of providers, fewer requirements, at-home dosing, insurance coverage, and room for spiritual and nonmedical use.
One participant described years of underground work, “keeping ourselves out of jail.” A clinical psychologist said trainees should get “their own supervised direct experiences with the psychedelics they’ll use for their patients.” A Students for Sensible Drug Policy ambassador asked regulators to “acknowledge that personal use or recreational use exists.”
One therapist group said it was “appalled” by “sexual misconduct by several prominent psychedelic therapists,” then urged FDA not to ban therapeutic touch outright.
Financial ties ran through the afternoon. One investor said disclosing all of his “would take me longer than my two minutes” and told the panel to “assume all of them.” The CEO of a Canadian psychedelic drug supplier was blunter: “Everything I’m about to say advantages my business. Please weigh it accordingly.”
Then Kevin Sabet, head of the Foundation for Drug Policy Solutions and Smart Approaches to Marijuana, said he was “one of the few here without a financial interest in the expanded use of psychedelics.”
“Psychedelics should earn approval the way any other class of drug does: through science and trials, not politics or podcasters,” Sabet said. “Medicine must be determined by safety, not popularity.”
He warned of “rushing headlong into massively commercializing these substances way before the science is there,” citing small samples, “suppressing negative results,” and sexual misconduct. He said psilocybin poison control cases among children under 12 have risen eightfold in five years, and pointed to more than 71,000 nonfatal EMS encounters involving suspected ketamine overdoses.
The trend he described has been documented in the peer-reviewed literature. Researchers at the University of Virginia School of Medicine found 4,055 psilocybin exposures among Americans ages 13 to 25 reported to poison centers between 2013 and 2022. Cases were flat through 2018, then climbed. By 2022 they had more than tripled among adolescents. About three in four required medical attention.
The record on approval is thinner than the hearing’s tone suggested. The last psychedelic to reach a decision point did not clear it. In 2024 an FDA advisory committee voted 10 to 1that the benefits of MDMA-assisted therapy for PTSD did not outweigh its risks, and 9 to 2 that effectiveness had not been shown. The agency asked for another Phase 3 trial. In April it 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 its own hearing notice that a voucher is not a finding of safety or effectiveness.
Sabet’s ask: “approval first, and then access.”
The next speaker was Susan Taymor Sagy, co-founder of the Coalition for Psychedelic Safety and Education.
“I came to this work through the most painful experience of my life,” she said. “My 21-year-old Shira died following psychedelic use.”
Sagy said she later joined other mothers “who lost adult children following psychedelic use,” and that they found “very little credible, accessible information” about the risks.
She said she supports rigorous research. But she warned that “FDA approval will carry enormous cultural weight,” and that a tightly regulated treatment could be read by the public as proof psychedelics are safe.
“Public health education cannot be an afterthought,” Sagy said.
Written comments are due October 5. The agency heard plenty Monday about access. Two speakers reminded it what is at stake.
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