Weekly Psychedelic Policy Briefing: September 20, 2026

Weekly Psychedelic Policy Briefing - September 21st, 2026

A Split at the FDA, an Oversold VA bill, and Alabama’s rescheduling hold is lifted

By Jack Gorsline

In this week's Psychedelic Policy Briefing, Psychedelic State(s) of America founder and investigative journalist Jack Gorsline covers three institutional developments. At a rare FDA part 15 hearing on psychedelics, speakers split over how tightly to control approved products while the federal panel listened in silence. The American Legion endorsed Senate bill S.4220 in terms the bill's text does not support. And Alabama withdrew a four-month-old objection to federal medical marijuana rescheduling, a sequence that previews how state adoption of a future psilocybin or MDMA rescheduling could unfold.

FDA Hearing Exposes Differing Approaches to Regulating Psychedelics

The Food and Drug Administration convened a public hearing on Sept. 14 at its White Oak campus in Silver Spring, Maryland, titled "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs." The agency sought comment on provider training and credentialing, patient safety, access, and data collection and standardization. The four-hour hybrid session heard two-minute comments from about 80 speakers selected from more than 200 requests, and it opened a stretch of Washington meetings on psychedelics that continued the next day at the Advanced Research Projects Agency for Health (ARPA-H). A panel of federal staff from FDA, the National Institute on Drug Abuse, the Substance Abuse and Mental Health Services Administration (SAMSHA), the Veterans Health Administration and ARPA-H listened. No member of the panel asked a speaker a question, even though speakers finished ahead of schedule.

The hearing capped a run of federal activity. President Donald Trump signed Executive Order 14401, "Accelerating Medical Treatments for Serious Mental Illness," on April 18. FDA finalized its guidance "Psychedelic Drugs: Considerations for Clinical Investigations" on July 14. On Sept. 8, HHS named Michael Davis permanent director of the Center for Drug Evaluation and Research, a role he had held on an acting basis since May; Davis was chief medical officer of the Usona Institute, a nonprofit psilocybin developer, from December 2022 to June 2025. The same day, Definium Therapeutics announced that FDA had granted Breakthrough Therapy designation to DT120, its orally disintegrating lysergide (LSD) tablet, for major depressive disorder, the program's second such designation after one for generalized anxiety disorder in 2024. On Sept. 9, Davis and three other CDER officials published "FDA's New Framework for Psychedelic Drugs" in the New England Journal of Medicine, describing expedited programs and regulatory flexibility for psychedelic development.

Testimony split over Risk Evaluation and Mitigation Strategies (REMS), the restrictions FDA can attach to an approval. Laurel Kilgour of the Psychedelic Bar Association urged the agency to study state-regulated access programs before setting controls. She argued that "REMS should not limit access to patient care," noting that "the track records of regulatory frameworks that have been in place for multiple years in Oregon and Colorado are instructive about barriers to entry and how these programs are playing out in practice." Kilgour told the panel that "meaningful choice among providers is itself a kind of safeguard, a consumer protection," and asked FDA to keep credentialing requirements affordable for small, independent providers. Others argued for caution. Eddie Jacobs, a Johns Hopkins researcher, recommended "an initial safety floor anchored closely to the trial context" and acknowledged it could limit access in the short term. Lawrence Goldkind, a former FDA staffer, was one of several speakers who asked FDA to write labeling and REMS drug by drug.

Greg Hutchinson, executive chairman of Emyria Limited, which is listed on the Australian Securities Exchange, described the three years since Australia's Therapeutic Goods Administration began allowing authorized psychiatrists to prescribe MDMA for PTSD and psilocybin for treatment-resistant depression outside clinical trials, on July 1, 2023. The pathway authorizes prescribers; the TGA has not evaluated or approved any product. Hutchinson said Emyria has conducted more than 500 dosing sessions, with treatment funded by the private insurer Medibank and by Australia's Department of Veterans' Affairs. "Real-world patients are more complex than trial patients, and we accept individuals that trials would typically exclude," Hutchinson said, including patients with elevated blood pressure and personality disorders. "Trials set the starting point, but frontline providers armed with data advance the field."

Sandy Samberg, a nurse practitioner and founder of the Psychedelic Education Partnership, testified that mainstream providers are not prepared for novel psychiatric treatments. She described a relative who had failed 10 depression medications and whose internist, psychiatrist, therapist and cardiologist all expressed confusion or reluctance about esketamine nasal spray, which FDA approved in March 2019. "Four highly trained, caring healthcare professionals, and not one of them felt equipped to help him navigate a treatment that had received FDA approval six years earlier," Samberg said. She said specialized facilitator training is insufficient on its own and that "responsible integration also requires equipping a wide range of providers with the knowledge and confidence to discuss the evidence, risks, and contraindications, and make appropriate referrals."

Jean C. Velez Rodriguez, a U.S. Marine Corps veteran and executive director of the Puerto Rico Institute for Psychedelic Science, Medicine, and Awareness (PRISMA), testified that 53% of respondents to a recent survey conducted by PRISMA reported lifetime psilocybin use. The figure describes that survey's respondents, not Puerto Rico's population. The National Survey on Drug Use and Health, which covers the 50 states and the District of Columbia, offers no comparison figure, because Puerto Rico's roughly 3.2 million residents fall outside it. "Territory inclusion should be a foundational design requirement for any federally endorsed data repository or coordinated registry network," Velez Rodriguez said. Without intentional engineering of those systems at the outset, Velez Rodriguez warned, "in our hands, we have a system that wasn't built to see us."

The testimony came six weeks after Gov. Jenniffer González-Colón signed Executive Order 2026-037, which directs Puerto Rico's Department of Health to assess whether to create a pilot research program for ibogaine, MDMA and psilocybin but does not authorize clinical use of any of them.

Lakisha Jenkins-Samuels of the Kiona Foundation pointed to the medical cannabis rollout as a cautionary example. She asked for transparent botanical drug characterization, independent channels for reporting harms and a place for Indigenous lineage keepers in drafting the rules. "Keep space for the people who traditionally hold this medicine. They belong in the room where the rules are written," Jenkins-Samuels said. "Community governance is safety infrastructure. Those are the simple facts."

Her request lands alongside the Advancing Botanical Drug Development Act of 2026 (H.R. 10150), a House bill introduced Aug. 27 by Rep. Lauren Boebert, R-Colo., that would bar FDA for 12 years from approving generic or hybrid versions of a newly approved botanical drug product, a protection that would attach to the product rather than to the plant or its traditional use.

The next day, on Sept. 15, ARPA-H held a Proposers' Day in Washington for ASCENT-IBO, a funding opportunity for accelerated Phase I and Phase II trials of ibogaine in opioid use disorder. Matt Zorn, HHS deputy general counsel, addressed the session remotely and urged attendees to build teams pairing cardiologists and clinical trial operators with traditional knowledge holders. "A lot of you here today are worth more on a team than you are individually," Zorn told the Proposers' Day audience. "It's our responsibility to move fast, it's our responsibility to fail quickly," he added, before warning, "We're not going to fund someone who's not going to move quickly."

Zorn's remarks come from a transcript of the session, which was not open to the press.

American Legion Endorses S.4220 but Describes a Stronger Bill Than Congress Wrote

At its 107th national convention in Louisville, Kentucky, held Aug. 28 to Sept. 3, the American Legion adopted a resolution titled "Novel Therapeutics for Mental Health Conditions and Traumatic Brain Injury" endorsing the Veterans Health Administration Novel Therapeutics Preparedness Act, S.4220. The resolution says the bill would establish "a dedicated VA Office of Novel Therapeutics and Centers of Excellence in each VA regional district."

However, the text of the bill does not say that. S.4220, introduced March 26 by Sen. Tim Sheehy, R-Mont., with Sens. Ruben Gallego, D-Ariz., Tammy Duckworth, D-Ill., and John Boozman, R-Ark., provides in section 7394 that the VA secretary "may designate one or more medical centers" as centers of excellence. That is discretionary and sets no number. The per-district language tracks section 7392(d)(11), which directs a new Office of Novel Therapeutics to identify at least one medical center in each Veterans Integrated Service Network for infrastructure and workforce readiness work. Identifying a site is not designating a center, and neither provision carries funding.

The bill would create the office, a Clinical Implementation Program for Emerging Therapeutics to test care delivery models, and a Veteran Advisory Committee, and it would direct VA to coordinate with DEA and other agencies on scheduling and reimbursement. It does not fund clinical trials or create patient access to any psychedelic. Its duties apply to approvals that have not yet occurred.

S.4220 was referred to the Senate Veterans' Affairs Committee on March 26, and the committee held a hearing on April 29. As of Sept. 19, Congress.gov records no further action and no House companion bill has been filed.

Alabama Withdraws Its Objection to Federal Medical Marijuana Rescheduling After Four Months

As reported by Marijuana Moment, on Sept. 17, the Alabama State Committee of Public Health, the governing body of the Alabama Department of Public Health, voted unanimously to withdraw its objection to the federal rescheduling of medical marijuana, letting the Schedule III classification take effect in state law.

The federal action was an order issued April 23 and published April 28 in the Federal Register that moved two categories from Schedule I to Schedule III: marijuana in an FDA-approved drug product and marijuana subject to a state medical marijuana license. Adult-use cannabis remains in Schedule I pending a separate DEA proceeding.

Under Alabama Code section 20-2-20(c), a federal rescheduling takes effect in the state 30 days after Federal Register publication unless the state health board objects; an objection requires published reasons, a hearing and a published decision. The committee objected May 21. "We certainly are going to do this," State Health Officer Dr. Scott Harris told members at the time, asking for the objection to buy time for implementation. After a July 22 public hearing, Harris said in September that he saw no issues with the change and that the department's legal team had resolved the agency's concerns. The objection itself cited Alabama's separate medical cannabis framework, which sits outside the health department's jurisdiction.

Most states use a similar automatic adoption model, but the mechanics differ. In North Carolina, the state commission that controls scheduling decides at its next regular meeting held 30 days after Federal Register publication, and if it objects it has 180 days to begin rulemaking. In Wisconsin, any interested party can object, which stays the change until the Controlled Substances Board rules. If DEA reschedules psilocybin or MDMA after an FDA approval, state adoption will depend on each state's version of that window, and Alabama shows a single state body can hold it open for months.

Disclosure: Psychedelic State(s) of America, which the author founded, collaborates with the Psychedelic Bar Association on events and joint video content. PBA's Laurel Kilgour is quoted in the first item.