Last week, the American Food and Drug Administration (FDA) held a public hearing on the potential future use of psychedelics. The hearing, which gave two minutes to randomly selected speakers from a pool of 200 submissions, is the latest step in American psychedelic policy, which is increasingly exploring the potential applications of these substances.
A listening panel consisting of FDA employees and partners from agencies like the National Institute of Health, Substance Abuse and Mental Health Services, and Veteran’s Health, listened to nearly 80 speakers for four hours.
“The first approval [of psychedelic medicine] is likely to not be far off, and the conditions set at launch are likely to stick,” Eddie Jacobs, Ethics Researcher at the Johns Hopkins Centre for Psychedelics & Consciousness Research, told TalkingDrugs.
“The agency is facing some big decisions about the rollout of psychedelics, and those decisions will shape both how much good they do and how much harm.”
The hearing
Topics for the hearing were grouped in categories covering training, credentials, patient safety, access and data standardisation. The vast majority of speakers filling the Maryland room or joining online were psychedelic business owners, advocates, therapists, and researchers.
Speakers, like Gregory Hutcherson of Australian publicly traded company Emyria Limited, spoke positively of developments there, setting an enthusiastic tone for the discussion. FDA officials unsuccessfully tried to stifle regular clapping during speeches.
“Three years ago, Australia did what the United States is now preparing to do,” said Hutcherson. “To date, we’ve conducted over 500 dosing sessions in what is a strict regulatory environment. We follow every patient for 12 months, and the results have been better than highly encouraging. They’ve also been durable. Moreover, we’ve seen no severe adverse reactions.”
The United States has been barreling towards legal psychedelics following an executive order signed by President Donald Trump in April, which directed the FDA to fast track psychedelics and allocate advanced research funding for these substances. Trump’s statements also specifically highlighted compounds like Ibogaine for treating PTSD in veterans. While the executive order threw psychedelics into the spotlight, their safety, approval and use protocols still need to go through a rigorous procedure.
Trump’s allocation of US$50 million into psychedelic research won’t accelerate FDA approval. Drug research is extremely expensive and cumbersome; and the existing stigma around psychedelics, as well as issues around its testing, means there’s much to prove on its safety and efficacy.
Large-scale data still needed
Jacobs advised caution, suggesting current data from clinical trials will not map perfectly on to large scale rollout.
“For the medical rollout of psychedelics, it should be a licensed prescriber signing off on eligibility, with a physician looped in to discuss where any flagged concern is medical in nature, During the dosing, there should be a doctor able to reach the patient quickly if something goes wrong medically,” Jacobs told TalkingDrugs.
“It’s important that there’s room for flexibility. Some safeguards might be traded against each other: how tightly patients are screened, how many experienced staff are in the room, how complex the patients being treated are. A clinic might dose a small group together rather than individually, compensating by treating less complex patients in that group. What we’d advise against is loosening several at once.”
The FDA hearing was a far cry from prohibitionist fears of psychedelic use, where only a handful of clinical studies were approved by the agency. While conversation on harms continues, it has become more nuanced. Speakers and presumably the FDA, seemed to all be operating on the assumption that psychedelics will soon become legal – the critical issue is now figuring out how.
Only Kevin Sabet, from the Foundation of Drug Policy Solutions, stood as a lone voice of critique, saying “psychedelics should earn approval the way any other class of drug does — through science and trials, not politics or podcasters,” referring to podcaster Joe Rogan’s early messages on the drugs influencing Trump’s decision making. Yet even Sabet’s messaging is not against their approval, but primarily for their cautious implementation.
Most speakers disclosed financial stakes in getting psychedelics approved and while safety was a common topic, it seemed overtaken by pharmaceutical companies sharing excitement over proprietary compounds in FDA-approval pipelines and several academic and private groups pitched their psychedelic-assisted therapy training programs.
While the FDA has no mandate over therapy, it remained a central topic for many speakers.
Therapy techniques and administration of psychedelics have been intertwined since the initial push for FDA approval of MDMA for PTSD by public benefit corporation Multidisciplinary Association of Psychedelic Studies (MAPS), which later rebranded to Lykos. Because while research suggests MDMA’s treatment benefits are influenced by the therapy it is combined with, acceptable therapeutic practice continues to be contentious.
In the September 2026 hearing, Genesee Herzberg, a psychologist and Trainer at Lykos Therapeutics, stated that “therapeutic touch must remain available to those who need it.” A loaded statement, as touching patients in altered states has been a contentious topic within psychedelic-assisted treatment.
Nese Devenot, a Psychedelic Humanities Researcher at Johns Hopkins has been a vocal critic of Lykos and Herzberg’s perspectives specifically. Devenot, along with colleagues at psychedelic watchdog group Psymposia, exposed Lykos for covering up questionable efficacy data during MDMA clinial trials and alleged sexual abuse. These findings were presented at a FDA hearing in June 2024, ultimately leading to the FDA rejecting the approval of MDMA for PTSD treatment.
“I have no optimism about the direction of psychedelic medicalisation within a system optimised for monopolisation and profit,” Devenot told TalkingDrugs. While Devenot did not secure a speaking window, they were present at the recent hearing. “There is every indication that the FDA is deferring to the lobbying interests of psychedelic pharmaceutical interests.”
“I am optimistic about the potential of decriminalisation, and of community-based, horizontal models without a power imbalance. In mutual aid models, individuals have agency to determine their own psychedelic practices along with their own interpretations of psychedelic experiences. In such models, there is less risk of cultic abuse from spiritual gurus or of being remodeled according to definitions of ‘healing’ that serve elite class interests.”
Decriminalisation was not a topic of discussion at the hearing, and the government panel asked no questions of presenters. Progress on the non-medical access – or at least the removal of criminal sanctions for possessing psychedelics – is happening, driven by localised campaigns across various American states and municipalities.
The FDA declined to comment on any future policy via email, but the topics chosen for the hearing — training, patient safety, access, and data collection standards – all point to a preference for a medical model focusing on the use of FDA-approved pharmaceuticals.
