Matt Metzger, a Marine combat veteran in Olympia, Washington, grows his own psilocybin mushrooms at home. He microdoses them to manage what his years overseas left behind. He is not enrolled in a clinical trial, not working with a VA-approved provider, not part of any program anyone is tracking. He is just one of the roughly 4.8 million American veterans who RAND researchers found have already used psilocybin, LSD, or MDMA in their lifetime — and, per Stars and Stripes’ reporting on that survey, one of the roughly half who have no idea whether mentioning any of it to his VA doctor could put his disability benefits at risk.
That uncertainty is still sitting there, unresolved, while the federal government just held the biggest public conversation about psychedelic medicine in more than fifty years.
The government is now moving faster to approve psychedelics than it is to protect the people already using them.
On September 14, the Food and Drug Administration convened a public hearing on the therapeutic use of psychedelic drugs at its White Oak campus outside Washington. More than 1,800 people registered. Roughly 80 speakers, chosen at random from over 200 who applied, got four minutes each across four hours, according to Behavioral Healthcare Network’s report from the room. It was, by any measure, a lot of federal attention for a class of drugs that spent the last five decades classified as having no accepted medical use at all. If you’ve used psychedelics on your own, in someone’s living room, at a retreat you paid for out of pocket because there was no legal alternative — you already know something the room spent four hours rediscovering: the drug was never really the hard part. What happens around it is.
Eighty Speakers, Four Hours, and No Agreement on Who’s Allowed to Run the Session
The hearing wasn’t about whether to approve any specific drug. It was about the plumbing — who gets credentialed to sit in the room while someone is on psilocybin, how patients get screened beforehand and monitored after, who pays, and how anyone collects data on what happens once these drugs leave the tight confines of a clinical trial. Marta Sokolowska, the FDA’s deputy center director, opened by saying the agency was “here today to listen,” per BioSpace’s coverage of the hearing. What the agency heard back was a field that agrees psychedelics can work and disagrees sharply on almost everything else.
Dr. Lida Fatemi, a hospice physician from New Mexico, told the FDA, “These are not medications you simply prescribe and dispense as doctors. The psychedelic care touches perception, memory, identity, profound and vulnerable territory,” according to NPR affiliate WFAE. Edward Jacobs, a researcher affiliated with Johns Hopkins, argued for caution over speed: “It’s better to start with stronger protections and adjust them as the evidence accumulates than to start with weaker protections and tighten them after harm,” he said. Psychiatrist Rajan Dunne pushed for physician-led treatment, telling the FDA that “access to psychedelics is not the same thing as access to good care.” Attorney Laurel Kilgour argued the opposite risk was just as real — that rules built too tight would just push people to do this without any oversight at all, Behavioral Healthcare Network reported.
Nobody at that hearing was arguing psychedelics don’t work. Two companies are already close: Compass Pathways’ synthetic psilocybin drug, COMP360, could reach patients with treatment-resistant depression as early as 2027 pending approval, WFAE reported, after Phase 3 results in more than 1,000 participants that the company calls the first statistically significant, clinically meaningful late-stage results for a classic psychedelic. That’s real. It’s also exactly why the plumbing fight matters: a drug that works in a 12-week trial with two therapists in the room, a screened participant pool, and a controlled setting is not automatically a drug that works the same way at your neighborhood clinic six months after approval, run by whoever got credentialed fastest.
An Executive Order Built the Fast Lane Before Anyone Built the Guardrails
None of this hearing happens on this timeline without Executive Order 14401. President Trump signed it on April 18, directing federal agencies to “accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs that could save lives,” in the order’s own language. Translated out of executive-order speak: the FDA now hands out “Commissioner’s National Priority Vouchers” — a designation that compresses the agency’s review of a new drug application down to one to two months, instead of the standard ten to twelve — to any psychedelic that’s already earned “Breakthrough Therapy” status, a separate designation meaning early trial data looked unusually promising. Since April, the FDA has issued three of those vouchers: to Compass Pathways’ psilocybin for treatment-resistant depression, a second psilocybin candidate for major depressive disorder, and methylone, an MDMA-family compound, for PTSD.
None of this hearing happens on this timeline without Executive Order 14401.
The order goes further than speeding up paperwork. It directs the FDA and DEA to build a “Right to Try” pathway specifically for ibogaine and other psychedelic compounds — a route that lets eligible patients access an investigational drug outside a clinical trial entirely. And in Section 5, it orders the Attorney General to review rescheduling any Schedule I compound the moment it clears Phase 3 trials for a serious mental illness, “so that rescheduling, if appropriate, may proceed as quickly as practicable.” That’s the federal government instructing itself to move a drug off the same legal shelf as heroin within roughly the same window it takes to renew a passport.
Here’s the history that should make you nervous about moving fast, even if you want this to work. In 1960, psychiatrist Sidney Cohen surveyed 62 researchers covering nearly 5,000 patients across 25,000 supervised LSD sessions and found strikingly low complication rates — no toxicity, no addiction, suicide attempts under two-tenths of one percent. His conclusion: LSD was safe, supervised. Within two years, watching it spread outside supervision — black-market pills, nobody screening anyone — Cohen reversed himself and started warning the country it was dangerous. That reversal helped feed the panic that produced the Controlled Substances Act of 1970, which shut down psychedelic medical research for nearly four decades. The drug didn’t change between 1960 and 1970. The infrastructure around it disappeared. That’s the exact gap this week’s hearing spent four hours trying to name before it happens again.
Nearly Five Million Veterans Already Answered the Question the FDA Is Still Asking
While Washington debates who should be allowed to guide a session, veterans are already having them — alone, unregulated, and without a straight answer from the one federal agency that’s supposed to have their back. The RAND Corporation’s 2025 Psychedelics Survey, drawing on more than 10,000 U.S. adults including 1,339 veterans, found LSD and psilocybin lifetime use among veterans running close to 19% and 18.6% respectively — figures the researchers extrapolate to roughly 4.8 million veterans nationally. Nearly a quarter support legalizing psilocybin outright. And 48% — essentially a coin flip — told researchers they weren’t sure whether bringing any of this up with a VA physician could jeopardize their benefits.
That’s not a hypothetical fear. It’s a policy vacuum. The RAND report notes the VA has neither published guidance telling veterans it’s safe to disclose psychedelic use to their care team, nor clarified that doing so outside a clinical trial won’t cost them their disability rating. The VA’s own public position, per Stars and Stripes, is that it “strongly discourages self-medicating or attempting to replace other mental health treatment options with psychedelics,” pointing instead to “proven, evidence-based treatments” already available at VA facilities — treatments that, for a meaningful share of veterans with treatment-resistant PTSD, have already failed. That’s the guy in Olympia growing his own mushrooms. He didn’t arrive there because he skipped the VA. Plenty of veterans arrive there because the VA is where the approved options ran out.
You know this dynamic even if you’ve never worn a uniform: the system tells you not to do the thing that’s helping you, offers no alternative that’s actually working, and then leaves the disclosure question — will this cost me — entirely on you to guess at. That’s not caution. That’s an agency outsourcing its own indecision onto the person with the least power in the relationship.
Approval Won’t Be the Hard Part. Paying For It Will.
Say the FDA does everything right from here — clean approval, solid training standards, real safety monitoring. The next fight is who can actually walk through the door. Full psilocybin-assisted therapy courses, combining the drug itself with the required hours of preparation and integration therapy around it, currently run somewhere between roughly $4,000 and $12,000 depending on the clinic and protocol, and Health Affairs Forefront has flagged that nobody — not insurers, not the companies developing these drugs — actually knows what the final price will settle at once a real market exists. If the FDA approves a psychedelic, federal law requires state Medicaid programs to cover it. Commercial insurers face no such requirement, and they’re waiting for real-world cost data before they commit to anything.
Say the FDA does everything right from here — clean approval, solid training standards, real safety monitoring.
Speakers at Monday’s hearing weren’t shy about naming what happens in that gap. Amna Aslam of Radial Health drew the sharpest distinction: “Efficacy is what a drug does in a trial. Effectiveness is what it does in the real world. The gap between them: infrastructure,” she told the FDA. Eric Jansen of the Balanced Veterans Network put it in blunter terms on behalf of the population this story keeps circling back to: “Veterans should not have to be forced to choose between suffering, going underground or leaving the country.” John Eaton of the Wounded Warrior Project added the line that should be stapled to every press release about this executive order: “Approval alone will not create access.”
That’s the honest read of where this stands. A White House with genuine enthusiasm for psychedelic medicine built the fastest regulatory on-ramp this drug class has ever had. It did not build the off-ramp — the guidance, the disclosure protections, the price controls — that determines whether the people who need this most, veterans especially, can actually reach it once it exists. Enthusiasm without infrastructure isn’t reform. It’s a press release with a start date.
There is a real, right-now thing you can hold onto here if you’re one of the millions already using these substances without a clinical trial or an insurance card behind you: nothing in this hearing, this executive order, or the FDA’s current posture threatens to criminalize you further, and the public comment period on exactly these access and equity questions stays open through October 5 — a door regular people, not just industry lobbyists, can still walk through.
The FDA hearing room had 1,800 names on a registration list and roughly 80 people who got four minutes to speak. The veteran in Olympia growing his own mushrooms wasn’t one of them, and neither were the millions like him. They don’t need the federal government to discover that psychedelics can help people who’ve run out of other options — they’ve already run that experiment, on themselves, without a research grant or a safety monitor, because the approved system left them nothing else to try. What they need now is for the same government that just built a fast lane for the drug companies to build one for the disclosure protections, the benefit guarantees, and the coverage rules that decide whether “approved” ever actually means “available.”
Sources Cited
- 01.AU.S. Veterans and PsychedelicsRAND Corporation
- 02.A
- 03.B
- 04.AExecutive Order 14401—Accelerating Medical Treatments for Serious Mental IllnessThe American Presidency Project (official text)
- 05.AConsiderations for Potential Future Therapeutic Use of Psychedelic Drugs Public HearingU.S. Food and Drug Administration
- 06.BReport from the FDA's hearing on psychedelic drugsBehavioral Healthcare Network
- 07.B
- 08.BPsychedelics get a hearing at FDAWFAE (NPR)
- 09.B
- 10.AThe Twelve-Thousand-Dollar Question: Who Picks Up The Tab For Psychedelics?Health Affairs Forefront
- 11.BLSD before Leary: Sidney Cohen's Critique of 1950s Psychedelic Drug ResearchIsis (University of Chicago Press) via PubMed
- 12.BFDA Awards Priority Voucher to Compass for Psychedelic Therapy in Treatment-Resistant DepressionPharmaceutical Executive
Filed Under
policytreatmentharm-reductionPsychedelics (general)FDAPsilocybin
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