FDA’s public hearing on the future of psychedelic drugs was scheduled to run four topic areas across three hours and forty minutes of testimony. Its first comment block, run from the agency’s White Oak campus on September 14, was organized around a single administrative question: once a psychedelic drug reaches approval, who has to be in the room, and with what training, when a patient takes it. FDA’s published agenda lists 44 registered speakers for that block; this account covers FDA’s opening remarks and the first twenty speakers the record examined here reaches. The block’s remaining speakers, and the hearing’s second segment on access and data-collection standards, with 36 more registered speakers, are outside this account.
Across all twenty speakers Behavioral Wire’s account covers, not one drew a follow-up question from FDA’s own listening panel. That absence matters for how this piece should be read. The testimony below is strong evidence of what stakeholders want FDA to consider. It is not evidence of what FDA has decided, or is leaning toward. The hearing did not resolve the field’s central disagreement. It surfaced it, cleanly, in public, for the first time at this scale.
What FDA said
Dr. Marta Sokolowska, FDA’s Deputy Center Director for Substance Use and Behavioral Health, gave five minutes of opening remarks before turning the floor over. She placed the hearing inside a specific sequence of federal action: Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illness,” signed April 18, 2026, directed FDA to prioritize psychedelic drug review. On April 24, FDA issued National Priority Vouchers, which compress standard review timelines to roughly one to two months, to three programs: Compass Pathways’ psilocybin candidate for treatment-resistant depression, the Usona Institute’s psilocybin candidate for major depressive disorder, and Transcend Therapeutics’ methylone candidate for PTSD. In July, FDA finalized clinical-investigation guidance for psychedelic drug sponsors and signed a data-sharing memorandum of understanding with the VA covering substance use and mental health conditions. CDER leadership, including two officials who sat on the hearing’s listening panel, published a commentary on the agency’s psychedelic framework in the New England Journal of Medicine on September 10.
Sokolowska’s stated purpose for the hearing was narrow and consistent with that record: FDA wanted perspectives on “training and credentialing, promoting patient safety, considerations for appropriate access, and best practices for data collection,” to inform “continued federal coordination.” She did not indicate which model, among the ones stakeholders would go on to propose, FDA favors. Neither did anyone else on the panel, which included not just the VA and SAMHSA representatives Sokolowska thanked by name but also a National Institute on Drug Abuse research analyst and a deputy director from ARPA-H’s Proactive Health office, per FDA’s own published agenda.
Who has to be in the room
The sharpest, most direct policy ask of the day came from a Sheppard Pratt psychiatrist, Rajan Dunne, who disclosed no financial interest and described seven years and roughly 200 participants across more than ten psychedelic clinical trials. His position: “for psychedelic drugs used to treat psychiatric illness, the FDA should require clinical oversight by a psychiatrist.” His stated rationale was specific, not general credentialism: diagnostic formulation that identifies features raising psychedelic-exposure risk, the expertise to manage complications, an understanding of how the drug and any accompanying therapy interact, and clinical responsibility for the treatment as a whole. He warned explicitly against a model that “earns its legitimacy through the language of psychiatry” while, under commercial pressure, sidelining the psychiatric expertise the treatment requires.
That position sat opposite several others in the same two hours. Heidi Allen, an associate professor at Columbia University’s School of Social Work, a former emergency department social worker who serves on the Medicaid and CHIP Payment and Access Commission, argued for interdisciplinary teams: nurses handling medical monitoring, peer support specialists, and master’s-level therapists doing the core clinical work, held together by shared competency, not “a certification layered on top.” Her stated reasoning was an access argument, not a safety concession: specialty behavioral health is already, in her words, “among the hardest care to access in this country, even for those with excellent insurance,” and she warned that narrow, high-cost provider requirements push patients who cannot find an affordable in-network provider toward less regulated, less safe settings instead. Laura Barrett of the University of Maryland asked FDA specifically to expand its guidance to let experienced nurses participate more broadly, paired with what she described as an interprofessional competency framework her school is developing across nursing, pharmacy, social work, and medicine.
A third cluster of speakers argued for models built around trained non-physician facilitators instead of any specific clinical license. Angela Fisher, founder of Bionic Bloom and a related training school, disclosed a direct financial interest in psychedelic clinical services and facilitator education, and argued that controlled clinical-trial conditions do not scale affordably and that a facilitator model, assessed through simulation and supervised practice, can cover the “entire episode of care” at lower cost. Sandy Samberg, a nurse practitioner who separately disclosed investing in psychedelic companies, made a related but distinct point: that mainstream clinicians, an internist, a psychiatrist, a cardiologist, in one patient’s own care team were each unfamiliar with an already-approved option, and argued the workforce gap is broader than any single specialist pipeline can close.
Between those positions sat a narrower, state-versus-federal argument. Liz Collins, a Colorado facilitator-in-training and licensed social worker, opposed folding facilitator oversight entirely into a federal, pharma-adjacent framework, arguing state licensing boards can sanction and remove providers practicing dangerously in a way a drug company has no unbiased incentive to do itself. Her specific ask was for FDA to treat facilitator administration as a REMS component and, where it wants to shape state practice, to issue guidance to the states, not supplant them.
None of these positions describes a consensus, and none should be read as one. A psychiatrist-oversight requirement, a nurse-inclusive interprofessional model, and a state-licensed facilitator model imply materially different staffing pools, training pipelines, and costs, and the speakers arguing for each were explicit that the others carry tradeoffs of their own.
Therapy, psychological support, or safety monitoring
A distinction ran under most of the testimony without always being named, and two speakers named it directly. Geoff Bathje, speaking from the Sana Healing Collective, noted plainly that “FDA doesn’t regulate psychotherapy,” but that FDA can regulate whether a patient remains in a supervised setting for the duration of a drug’s acute effects, a narrower, administrative safety requirement distinct from the therapy question entirely. Mark Rasenick, representing the American Brain Coalition as a neuroscientist, not a clinician, made a version of the same point from the opposite direction, that the specific value and design of monitoring and therapist involvement is “difficult to assess and not in the province of the FDA,” while separately flagging that psychedelic trials cannot be truly placebo-controlled and that expectation bias is hard to rule out, a methodological caution offered by someone still urging broader access.
Erin Atkinson, founder of Prism Wellness, drew a related distinction from a treatment-design angle: that psychedelic treatment “does not always unfold in a straight line,” that the dosing session is an event but the treatment is a process, and that preparation and integration support, helping a patient prepare for, process, and incorporate the experience, are separate clinical competencies from administering the drug itself. Her point connects to informed consent specifically: because the subjective experience is itself clinically relevant and can “profoundly and unpredictably alter perception, emotion, memory, and identity,” she argued consent for a psychedelic is a materially different task than consent for an ordinary medication, one that ongoing, psychedelic-specific clinical consultation is needed to support.
Read together, the testimony maps onto at least three distinct categories that a single word, therapy, tends to collapse: the supervised setting FDA’s own labeling and REMS authority can reach; the preparation, integration, and informed-consent work several speakers treat as a necessary clinical competency regardless of who holds it; and psychotherapy itself, which remains a state-regulated scope-of-practice matter no federal drug approval directly controls.
How much safety infrastructure the system can carry
The clearest real-world evidence cited in the segment came from Lisa Ginzburg, founder of the Changa Institute, who referenced the first multisite assessment of safety and outcomes of Oregon’s state-regulated psilocybin program, a JAMA Network Open cohort study led at Oregon Health and Science University. That study followed 346 participants across 24 licensed service centers and found four serious behavioral adverse reactions, 1.2 percent of the sample, with three of the four followed by a psychedelic-associated emergency department visit at a later point. The detection gap Ginzburg cited checks out against the paper directly: among those four cases, facilitators flagged only one as a serious reaction in real time, a violent behavioral reaction that led to hospital transport during the session itself; a second was reported during the session only as mild stomach contractions, and the remaining two showed no facilitator-reported reaction during the session at all. Her conclusion, that unsupervised or under-licensed settings would likely miss these events entirely and that longitudinal follow-up is what catches them, is a defensible read of what her cited study shows. Her specific ask was for FDA to create a recognized accreditation standard for the facilitator workforce.
That same tension, between how much oversight a safe program requires and how much the delivery system can absorb, ran through testimony that never mentioned Oregon at all. Nikita Tsimmer, cofounder of Fountain Health, argued screening should be medical as well as psychiatric and pushed for a single coordinated system spanning screening through monitoring, plus a shared data language covering what happens between treatments, not only during them. Derek Kozlowski, an Iraq War veteran describing years of underground psychedelic work with fellow veterans, warned from the opposite direction that his own typical sessions run roughly eight hours, a duration he said “doesn’t fit many clinical models,” and urged FDA not to design a framework so restrictive that people already doing the work are pushed back underground.
What FDA did not reveal
The hearing’s format itself limits how much can be inferred about the agency’s own preferences. FDA’s published agenda explicitly reserved space for panel members to ask clarifying questions after each speaker. Across the twenty speakers this account covers, none did. That silence is not evidence FDA agrees with any particular model, disagrees with one, or has already decided. It is evidence that, on this record, the public comment period functioned as exactly what a Part 15 hearing is designed to be: a channel for the agency to receive positions, not a forum in which it stated any. What is verifiable is narrower: FDA structured the hearing’s very first comment block, ahead of access and data-collection questions, around exactly the provider-qualification fight described above, which means the agency itself treats the question as open and consequential enough to hear first, independent of which answer it eventually gives.
Why this matters commercially
The stakes are not abstract. Compass Pathways, Usona, and Transcend Therapeutics, the last now a wholly owned subsidiary of Otsuka America after an acquisition that closed June 12, 2026, are operating under National Priority Vouchers that compress FDA’s review timeline to roughly one to two months, meaning a delivery-model decision, whenever FDA makes one, could arrive on a compressed clock relative to a normal drug approval. What each proposed model would mean commercially differs by design, not by degree. A psychiatrist-oversight requirement, on the rationale its proponent gave, concentrates delivery in the smallest, most credentialed, and most expensive provider pool, in direct tension with a separate, unrelated speaker’s own point that specialty behavioral health access is already strained under existing reimbursement and staffing constraints. An interdisciplinary or nursing-inclusive model is argued by its proponents to expand supply and lower cost, though no speaker addressed how FDA would draw the scope-of-practice lines such a model requires. A facilitator-centered model, argued for in part by speakers with a direct financial stake in that market’s growth, a fact each disclosed, not concealed, would depend on an accreditation infrastructure that, per Ginzburg’s own testimony, does not yet exist in a form FDA has recognized. Whether state licensing regimes in Oregon and Colorado get preserved, preempted, or coordinated into whatever national framework eventually emerges remains, on this record, genuinely unresolved.
What to watch
The hearing’s second segment, on access and data-collection standardization, ran the same afternoon and is not part of this account; whether its testimony reinforces or complicates the provider-qualification fault line described here is a distinct question worth checking directly. Beyond that, the concrete markers are the ones FDA itself has already set in motion: the National Priority Voucher timelines now running for Compass, Usona, and Otsuka-owned Transcend, any follow-up guidance FDA issues specifically addressing delivery-site or provider-credentialing standards, and whether the docket’s written comment record, still open to the same stakeholders who spoke, converges toward one model or preserves the same split this hearing put on the public record.