Something unusual happened at the FDA's White Oak campus recently. Roughly three hundred people showed up in person — with another thousand watching online — for a rare public hearing on whether, and how, psychedelics might one day be approved as therapeutic drugs. If you've been following the slow, sometimes maddening march of psychedelics toward mainstream medicine, this was a moment worth paying attention to.

These aren't your standard regulatory meetings. The FDA has only convened two of these so-called Part 15 hearings since 2020. They're informal, discretionary, and usually reserved for topics the agency considers to be in the public interest. Getting one for psychedelics is, in itself, a signal.

Around eighty people delivered two-minute comments across the afternoon. Half in person. Half beamed in by video. The audience? Overwhelmingly people from inside the psychedelics field — researchers, clinicians, drug developers, veterans' advocates, and a fair number of true believers. If you were expecting a balanced roomful of skeptics and supporters, this wasn't it.

What Actually Came Up

The comments ranged widely, but a few themes kept surfacing. Provider training. Patient safety. Access. Data collection. None of it was groundbreaking for anyone who's been tracking this space — but the accumulation of voices, all pointing in similar directions, is telling in itself.

One repeated plea: don't treat psychedelics as drugs that work in isolation. Speakers like Lawrence Leeman from the University of New Mexico pushed for the framing of psychedelic-assisted therapy, with real weight given to preparation and integration. Psychologist Geoff Bathje said he'd been disappointed to watch the agency downplay the therapeutic relationship in clinical trials, treating the drug effect as if it could be cleanly isolated from context.

Here's the wrinkle, though. The FDA doesn't regulate psychotherapy. It regulates drugs. So even sympathetic staffers are working within a legal frame that wasn't built for what psychedelic treatment actually looks like in practice.

Should Therapy Be Required? The Field Can't Agree

Not everyone wanted mandatory psychotherapy baked into approvals. Peter Hendricks, a professor at the University of Alabama at Birmingham, argued that a blanket therapy requirement would hit hardest on people who already can't afford quality mental health care. Many patients in his trials, he pointed out, are low-income and uninsured. Requiring them to also access a licensed psychotherapist — often out of pocket — could effectively lock them out.

His suggestion was cleaner: let the label specify which of three models the evidence actually supports. Safety monitoring. Psychological support. Or full-blown psychotherapy. Different molecules, different indications, different frameworks.

Labels aren't just paperwork, by the way. Amna Aslam from Radial made the point that insurers build their coverage rules directly from what's on the label. Write it too narrowly, and reimbursement becomes a nightmare. Write it thoughtfully, and coverage might actually reach the people who need it.

The REMS Question — How Tight Should the Guardrails Be?

Another recurring theme was how restrictive the safety scaffolding around any approval should be. In FDA-speak, that's REMS — Risk Evaluation and Mitigation Strategies. Multiple speakers asked the agency to design REMS on a drug-by-drug basis, rather than slapping a single template across the whole psychedelic class. Lawrence Goldkind, a former FDA staffer himself, pushed for exactly this kind of tailoring.

Advocates on this front will likely be pleased. From what we understand, a shared class-wide REMS is very unlikely, at least in the near term.

The concern underneath all of this is access. Laurel Kilgour, speaking for the Psychedelic Bar Association, put it bluntly: an overly aggressive risk mitigation framework can actually undermine safety, because it pushes people toward underground alternatives with zero oversight. If the clinic route is impossibly gated, patients will find another route. They always do.

Christian Reed, a retired Green Beret speaking on behalf of at-home ketamine company Mindbloom, took this argument even further. Don't lock this inside clinics in a handful of major cities, he told the panel. Don't weigh it down with so much overhead that insurers walk away.

The Cautious Voices in the Room

Not everyone was in a hurry. Eddie Jacobs, a researcher at Johns Hopkins, argued for a conservative initial rollout — what he called a safety floor anchored close to the trial context. Yes, he admitted, this will limit access at first. Yes, it puts extra weight on providers. But starting stronger and loosening as evidence accumulates, he said, is better than the reverse.

Amber Barnato from Dartmouth — a certified psychedelic-assisted therapy facilitator herself — called FDA approval of psychedelics “ethically defensible” but flagged that the underlying evidence is of low certainty. Small trials. Functionally unblinded designs. Her fix was to build ongoing comparative effectiveness studies via registries that actually track things consistently: patients' intentions, expectations, the quality of preparation and integration. Right now, she said, those are captured haphazardly across trials, when they're captured at all.

Then there was Susan Taymor Sagy, whose 21-year-old daughter died following psychedelic use. Her comment cut through the room. Public education, she told the panel, cannot be an afterthought. An FDA approval carries enormous cultural weight, and the messaging around it needs to reflect that.

The Lone Skeptic

Only one speaker showed up as an outright critic: Kevin Sabet, a familiar figure in drug policy debates. He joined virtually, despite being listed to attend in person. He opened by pointing out he had no financial disclosures to make — a barbed reference, presumably, to the many speakers who did.

Psychedelics, Sabet argued, should earn approval through science and trials, not through politics or podcasters. He hit the studies for small sample sizes and methodological weaknesses. He also seemed to gesture at Americans for Ibogaine co-founder Bryan Hubbard, who had recently invoked JFK's line about how those who make peaceful revolution impossible make violent revolution inevitable — while advocating for ibogaine access at a veterans' convention.

Whatever you think of Sabet's politics, his was one of very few voices at the hearing not cheering the process forward. The rest of the room, as one attendee described it, felt at times a bit self-congratulatory. The moderator asked people twice not to applaud. A few clapped anyway.

Beyond Mental Health

Most comments focused on mental health indications — depression, PTSD, addiction, the usual suspects. But a small chorus tried to widen the frame. Speakers from Clusterbusters, the Psychedelics and Pain Association, and Cy Biopharma discussed psychedelics for pain, particularly for something like cluster headache, where the standard trial design might not even fit. Cluster headache patients often benefit from sub-perceptual or low doses rather than the full ceremonial experience.

One cochlear implant recipient even suggested psychedelics might help patients accelerate the neural learning curve required to make sense of the device. Whether that gets any regulatory traction is another question — but it's a good reminder that the therapeutic possibilities here don't stop at psychiatry.

The Silence That Said Everything

The most striking part of the whole afternoon may have been what didn't happen. In previous Part 15 hearings, back-and-forth between the federal panel and commenters is a normal feature of proceedings. Microphones had been placed in front of each of the nine panellists. The agenda allowed for it. Speakers even rattled through their two-minute slots ahead of schedule, leaving time to spare.

And yet, aside from opening remarks, not a single panellist asked a question. Not one word.

That silence is what leaves people in the field guessing. What does the FDA actually want to know? What are its private concerns? Which comments landed and which slid past unnoticed? The format didn't reveal any of it — a conveyor belt of two-minute pitches, absorbed in stone-faced quiet by the people who'll eventually write the rules.

What This Means If You're Considering a Retreat

If you're reading this because you're weighing whether plant medicine or a psychedelic retreat might help with something you're carrying — depression, addiction, trauma, a life pattern you can't seem to break — the takeaway is a mixed one. The regulatory path in the U.S. is inching forward. Slowly. With real disagreement inside the field about what safe access should look like.

What it isn't yet is a system you can walk into and get reimbursed for. And even after approvals arrive, the clinical model — dosing in a sterile room, minimal preparation, limited integration — may look very different from what people describe finding in a well-run ceremonial retreat. The debate at White Oak was, in a way, an argument about how much of the ceremonial and relational context to preserve when the medicine gets professionalised.

If you want to explore what's already available in the current landscape — legitimate, well-facilitated ayahuasca ceremonies, psilocybin retreats, ibogaine programs for addiction, and other plant-medicine offerings — a curated selection of retreats can be browsed on our marketplace here. Whatever the FDA eventually decides, the older traditions aren't waiting on Washington, and for many people that's exactly the point.