FDA Hearing Puts Psychedelic Drug Access and Reimbursement in Focus

The US Food and Drug Administration (FDA) held a landmark public hearing on September 14, 2026 on how psychedelic drug products might one day be used therapeutically, drawing more than 1,800 registered attendees and nearly 80 scheduled speakers to its White Oak campus in Silver Spring, Maryland. Run under 21 CFR Part 15, the session signals the agency is moving past the question of whether psychedelics work and into the harder questions of psychedelic drug access, delivery and reimbursement.

The hearing sits inside a broader federal effort that began in April, when President Trump signed Executive Order 14401, Accelerating Medical Treatments for Serious Mental Illness. Since then the FDA has issued priority review vouchers to three companies studying psilocybin for treatment-resistant depression and major depressive disorder and methylone for post-traumatic stress disorder, published a finalized guidance on psychedelic clinical investigations, and signed a memorandum of understanding with the National Institute on Drug Abuse. The agency’s framework was also set out in a New England Journal of Medicine commentary in early September.

Provider training and credentialing

Speaker after speaker argued that a license alone is not enough. Heidi Allen, a Columbia University professor and a commissioner on the Medicaid and CHIP Payment and Access Commission, said the agency should build on a care team holding the right interdisciplinary competencies rather than adding a new credential on top. She pointed to the psychedelic therapy training program she launched at Columbia, which is embedded in the master of social work curriculum so students pay no extra tuition.

“We don’t need a one-size-fits-all training model. We should apply psychedelic exceptionalism only when truly necessary.”

Aaron Atkinson, a licensed clinical social worker who founded Prism Wellness, described preparation and integration as distinct clinical competencies that must be taught and assessed, not picked up on the job. A recurring fault line was whether care should be psychiatrist-led, as Rajan Dune, a psychiatrist at Sheppard Pratt, urged, or opened to a broader interprofessional workforce.

“Access to psychedelics is not the same thing as access to good care.”

Nurses, pharmacists and peer support specialists all made the case for a wider tent. Lynn Marie Morski of the Psychedelic Medicine Association and Lisa Ginsburg, who runs a psilocybin facilitator training program across Oregon, Colorado and New Mexico, pressed for independent accreditation standards for training programs. Jeremy Rudy of Saba Collective argued credentialing should rest on demonstrated competence rather than training hours, and that provider readiness records should be portable across sites and sponsors.

Psychedelic drug access and reimbursement

The sharpest signal on market access came from speakers who argued that approval alone will not deliver care. Amna Aslam, from a brain medicine network delivering TMS, ketamine and esketamine across 27 clinics in seven states, pointed out that esketamine was approved in 2019 with monitored administration and a risk evaluation strategy, yet took five years to reach scale. She urged the FDA to write labels with payers in mind, standardize data before launch, and work with CMS on a permanent CPT code.

“Approval alone is not access. A breakthrough therapy nobody can reach is not a breakthrough. It is a press release.”

Tiffany Callas, a nurse who founded the Spirit Nurse Psychedelic Community, said Medicaid does not cover ketamine injections or lozenges in her area, a region with a large military population. John Dalton of the Nevada Coalition for Psychedelic Medicines noted that nearly 87% of Nevadans live in a federally designated mental health professional shortage area, with roughly nine psychiatrists per 100,000 residents against more than 120 licensed clinical social workers, marriage and family therapists and counselors. He urged the agency to preserve a non-physician lead monitor model rather than a blanket 15-minute physician arrival standard.

Lawrence Goldkind, a former acting division director in the FDA’s Center for Drug Evaluation and Research, cautioned against templated class labeling and a single risk evaluation strategy for all psychedelics, warning that onerous requirements would limit care from solo practitioners, small facilities and rural caregivers. Heather Cooper, director of the Center for Psychedelic Public Health, framed the access question around prevention: if the US Preventive Services Task Force grades an intervention A or B, insurers must cover it without cost sharing, but psychedelic research would need to be designed with primary care delivery in mind.

Melissa Lavasani, founder and CEO of the Psychedelic Medicine Coalition, flagged the women’s health data gap, noting that just 8.8% of NIH research grant funding went to women’s health research from 2013 to 2023 and that women experience adverse drug reactions nearly twice as often as men. Greg Hutcherson, chairman of Australia-listed Amir Limited, described Australia’s experience since the Therapeutic Goods Administration authorized psychiatrist prescribing of MDMA and psilocybin in October 2023: more than 500 dosing sessions, 12-month follow-up and funding now flowing from Medibank Private and the Department of Veterans’ Affairs. Nick Kadysh of PharmAla Biotech warned that Australia’s original requirement for a psychiatrist to remain on-site with a psychologist priced patients out until the regulator relaxed it, and urged the FDA to hold the line on good manufacturing practice as the precondition for access.

Cautions and next steps

Not every voice was bullish. Kevin Sabet, head of the Foundation for Drug Policy Solutions and a former White House drug policy adviser, argued that psychedelics should earn approval through science and trials rather than politics or podcasters, citing small sample sizes and safety signals including rising hallucinogen emergency visits and suspected ketamine overdoses. A co-founder of the Coalition for Psychedelic Safety and Education, whose 21-year-old daughter Shira died following psychedelic use, urged a coordinated national public education effort so that FDA approval does not normalize unsupervised use.

For market access, the hearing’s clearest takeaway is that reimbursement is the binding constraint, not efficacy. Speakers repeatedly tied coverage to label precision, CPT coding and the design of risk evaluation and mitigation strategies. The written docket, FDA-2026-N-7542, stays open until 11:59 pm Eastern time on October 5, 2026, and the agency is expected to read those comments as closely as the oral ones.

Source: FDA public hearing “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs,” September 14, 2026, White Oak Campus, Silver Spring, Maryland (FDA event page; Federal Register docket FDA-2026-N-7542).