FDA就致幻剂药物获批后的给药、监测与安全举办公共听证会，未形成审批决定

FDA holds psychedelic hearing as historic approval looms
Biotech
As ‘cultural weight’ of a psychedelic approval looms, FDA hearing focuses on access and safety
By
Darren Incorvaia
Sep 14, 2026 6:00pm
psychedelic drug
Food and Drug Administration (FDA)
mental health
FDA approval
As the FDA marches toward the likely first approval of a psychedelic medicine, the agency today convened a hearing seeking public input on how these drugs should be used, monitored and continuously studied in the real world.
The biggest question swirling around the hearing was one of access. Should a psychedelic medicine be approved, who would the FDA allow to administer it? And how would that decision impact patients' ability to actually receive the treatment?
The current wave of biotechs pursuing psychedelic drugs has consciously moved away from the model popularized by states like Oregon and Colorado, where psychoactive substances like psilocybin are used to assist psychotherapy. Instead, companies like Compass Pathways and Definium Therapeutics administer their drugs during supervised treatment sessions, where a healthcare provider serves as a dosing session monitor (DSM).
This distinction is meant to isolate the ability of Compass’ synthetic psilocybin compound and Definium’s LSD formula to treat mental health conditions like depression and anxiety. But many who spoke at the hearing urged the FDA to recognize the important role psychotherapy plays in treatment.
“I've been disappointed to see the FDA minimize the importance of the therapeutic relationship in psychedelic research for the sake of isolating drug effects in clinical trials,” Geoff Bathje, Ph.D., a clinical psychologist and co-founder of ketamine-assisted therapy practice Sana Healing Collective, said during the hearing.
“We do now have a few trials that have studied ketamine and other psychedelics with and without therapy, and so far they've confirmed that these substances are more effective with therapy,” Bathje said. “The industry will seek to minimize costs of this new area of treatment, but to do so at the expense of the therapeutic relationship would be a mistake.”
The DSM approach has thus far led to clinical trial success for psychedelic biotechs. Definium today
announced
its third phase 3 trial success in just 12 weeks, and Compass Pathways is now in the process of a rolling new drug application submission to the FDA following two
pivotal wins
in depression.
Even if the FDA ultimately allows DSMs to be present during psychedelic experiences rather than a therapist, it is still an open question how such individuals should be trained and credentialed.
“For psychedelic drugs used to treat psychiatric illness, the FDA should require clinical oversight by a psychiatrist,” Rajan Dunne, a psychiatrist at Sheppard Pratt, said during the hearing. “Good psychedelic care requires the full scope of psychiatric expertise. It requires thorough diagnostic formulation, including identifying features that increase the risks of psychedelic exposure, and the expertise to identify and manage complications.”
Many speakers were those who operate education and credentialing services for would-be psychedelic care providers, and they largely urged the FDA to take steps to bolster the psychedelic workforce and ensure those administering the therapies are properly trained.
“My request is simple: make workforce readiness central to the future of psychedelic therapy, support rigorous, transparent training standards, and recognize that safe delivery requires prepared human beings and communities, not just prescribing authority,” Lida Fatemi, a palliative care physician and co-founder and CEO of Conscious Physicians Psychedelics Academy, told the FDA today.
Still others disputed whether a specialized workforce is needed at all—nurse practitioner Tina Braddock said during the hearing that her profession has got things covered.
“We do not need to build a new workforce,” Braddock said. “Nurses are already here, licensed, trained, deployable now. Nurses make this safe. Nurses make this accessible. Nurses can bring it to the people who need it.”
Accessibility came up again and again during the hearing, largely because the FDA listed a requirement in a
July guidance
that if the lead monitor of a psychedelic dosing session is not a physician, an on-call physician must be able to reach the patient within 15 minutes.
“In frontier Nevada and other western states, that requirement could exclude otherwise qualified clinics from providing care,” Jon Dalton, president of the Nevada Coalition for Psychedelic Medicines, said in his remarks. “As you shape post-approval requirements, we urge you to preserve the non-physician lead monitor model and avoid automatically carrying over a blanket 15-minute physician arrival standard.”
Reality check
Though speakers shared different opinions on how FDA-approved psychedelic therapies should operate in the real world, they were all largely gung-ho about the field as a whole. That changed late in the hearing, when Kevin Sabet, Ph.D., head of the Foundation for Drug Policy Solutions and a former White House advisor on drug control policy, reminded the crowd of how psychedelics got to this moment.
“Psychedelics should earn approval the way any other class of drug does—through science and trials, not politics or podcasters,” Sabet said, referring to podcaster Joe Rogan’s
Oval Office visit
that sparked President Donald Trump’s current enthusiasm for the drug class.
Trump signed an
executive order
with Rogan beaming behind him on April 18, and not long after the FDA
issued
three Commissioner’s National Priority Review vouchers to three psychedelic drug developers: Compass Pathways, Transcend Therapeutics and the Usona Institute.
“I'm concerned we are rushing headlong into massively commercializing these substances way before the science is there, and not learning the lessons from the past,” Sabet cautioned. He said many of the phase 3 trials so far have had relatively small sample sizes despite targeting massive patient populations. Anxiety disorders, for example, are
estimated
to affect roughly one in six adults in the U.S.
Sabet also called psychedelic studies “rife with methodological issues,” including “researchers who use the drugs being studied for recreational purposes, poor sampling, suppressing negative results, as well as sexual misconduct.”
Sexual misconduct by providers came up several times during the hearing as a key safety concern, as it is a
known issue
in the field.
Sabet and others also highlighted the adverse events that can arise from taking psychedelics, most notably the known cardiac risks. These risks came into sharper view when the speaker after Sabet, Susan Taymor Sagy, began her remarks.
“I came to this work through the most painful experience of my life,” Sagy, co-founder of the nonprofit Coalition for Psychedelic Safety and Education, said. “My 21-year-old Shira died following psychedelic use.”
For Sagy and others who spoke of safety concerns, pre-screening patients' health before treatment is critical, alongside effective supervision of the treatment itself.
“I strongly support rigorous research into therapeutic potential for psychedelics, but as we move toward possible FDA-approved psychedelic therapies, we need to think beyond the clinic,” Sagy said. “FDA approval will carry enormous cultural weight.”
Related
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psychedelic drug
Food and Drug Administration (FDA)
mental health
FDA approval
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Biotech