Eighteen Thousand People Registered to Watch the FDA Plan Psychedelic Medicine. Almost No University Teaches How to Give It.

Tina Braddock is a nurse practitioner, and when she got her turn at the FDA’s psychedelics hearing on September 14, she made an argument about headcount. The nursing workforce, she told the panel, is “already here, trained, deployable now.” Another speaker, Rajan Dunne, a psychiatrist at Sheppard Pratt, said the opposite in so many words: “good psychedelic care requires the full scope of psychiatric expertise.” Both were speaking into the same four-hour afternoon on the agency’s White Oak campus in Silver Spring, Maryland, and both were describing a job that does not exist yet.

The FDA is deciding how to approve psychedelic medicine before anyone has decided who gets to sit in the room with you while it works.

More than 18,000 people registered for the hearing, and about 80 speakers were drawn from more than 200 requests, according to Foley Hoag’s account. It grew out of Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illness,” signed April 18. Notice what it did not do. It took up no individual drug application, said nothing about the DEA’s legal classification of these drugs, and did not touch legalization or decriminalization. It was a hearing about delivery: who gives the medicine, where, with what training, and who pays. Written comments close at 11:59 p.m. Eastern on October 5, per the FDA’s hearing page, which is tomorrow.

The drug is the easy part. The room is the hard part.

Psychedelic-assisted therapy means a person takes a psychedelic drug in a supervised session, with trained people present, usually for hours, and then does follow-up work afterward to make sense of what came up. Everyone at the hearing agreed on that outline. What they could not agree on was where the benefit comes from. Geoff Bathje, a clinical psychologist, told the panel that comparisons “have confirmed that these substances are more effective with therapy.” Others pushed to isolate the pharmacology, to find out how much is the molecule and how much is the relationship.

That second question is a psychology question, and it is not academic if you are the one lying there. Psychologists call the trust between a person and the one helping them the therapeutic alliance. In a session where your sense of self can loosen for hours, the person beside you is not a detail. If the alliance is the active ingredient, then the training of the person beside you is part of the medicine, and a drug label that ignores it is half a label.

Which brings the fight over staffing into focus. The hearing heard three models: a psychiatrist required at every session, nurse-led teams like the one Braddock described, and what Psychiatric Times called sponsor-specific credentialing, meaning the company that makes the drug certifies the people who give it. One speaker urged that any safety program the FDA attaches to approval be “proportionate and not overly prescriptive”. Those programs, called REMS, are controlled-distribution rules the FDA can require for drugs with serious risks.

Name the gate before anyone claims this is real. No psychedelic is approved for psychiatric use today. Whoever may supervise a session will end up determined by an approved label, by whatever REMS the FDA imposes, and by each state’s licensing law for nurses, psychologists, and counselors. A federal framework is not the same as a nurse in your state being allowed to run a session next spring.

Nobody is teaching the people the plan depends on

Sarah Norman, executive director of BrainFutures, spent her time on the unglamorous part. Citing a survey of 418 academic leaders, she reported that 79% agree psychedelics show promise for psychiatric disorders, yet 92% of their programs lack the faculty to teach it. Three percent have built a therapy-specific track. None offer a certificate. “Workforce development isn’t an overnight thing,” Norman said. “If we wait a year until approval, we’re really not going to be able to provide this service until years later.”

“If we wait a year until approval, we’re really not going to be able to provide this service until years later.”

Set that against the clock. HCPLive reported that rescheduling by the DEA is expected to follow FDA approval by roughly 90 days. Law can move in a quarter. Training moves in years. And the pipeline is not hypothetical: the FDA gave a second Breakthrough Therapy designation, its fast-lane label for promising drugs, to DT120, a lysergide tablet, for major depression. Reported Phase 3 data show an 8.1-point improvement over placebo on a standard clinician-scored depression questionnaire at week 6, held through week 12. That is one trial, in depression rather than addiction, and I have not seen it in a peer-reviewed journal. It is still the kind of result that makes the staffing question urgent rather than theoretical.

Money is the other gate. One commenter called reimbursement “a safety question,” because a clinic that cannot be paid will not stay open to do the follow-up. Speakers also raised rural sites and the thin share of research funding aimed at women. If the model that wins costs a private-pay fortune, it will reach the people who already have everything else.

We have watched belief outrun the room before

On August 9, 2024, the FDA turned down MDMA-assisted therapy for PTSD, saying the application had “significant limitations” that kept it from concluding the drug was safe and effective. An advisory panel had already voted overwhelmingly against it. Lykos Therapeutics’ CEO, Amy Emerson, called the decision “deeply disappointing” and said her heart broke for veterans and first responders. More than 80 members of Congress had signed letters urging approval, and veterans had rallied on Capitol Hill. None of it stood in for trial data the agency could trust. Two years later the same field is back at the same agency, with a nurse, a psychiatrist, and a drug company each saying they are the missing piece. The pattern is old: belief shows up first, infrastructure gets built last, and the people left holding the patients are the ones who believed.

What is still yours, and what to do this week

If you are in recovery and someone has told you a mushroom is about to cure addiction, hold that loosely. Nothing the FDA took up on September 14 is an approved treatment for addiction, the executive order is about serious mental illness, and the hearing reviewed no individual drug. Anyone selling you a supervised session today outside a registered clinical trial is selling something no regulator has reviewed. What is still yours, tonight: buprenorphine, methadone, and naltrexone for opioid use disorder, and the free, 24-hour SAMHSA National Helpline at 1-800-662-4357.

If you run a program, there are two concrete moves before Monday night. Submit a comment through the FDA docket before 11:59 p.m. Eastern October 5 and tell the agency what training your nurses, counselors, and peers would need, in your words, with your numbers. Then put one item on this week’s team agenda: who on staff would handle preparation and the integration sessions after a dosing day, and what would they need to learn first? Add one intake question while you are at it. Ask whether the person has used psilocybin, MDMA, or ketamine outside care, where, and with whom. People are already doing this. Your chart should say so. For context on how a different drug in this family is already reshaping the clinic, see our ketamine case-report spotlight and the rest of our psychedelics coverage and policy desk.

Braddock may well be right that the nurses are already here. What the FDA cannot settle in one afternoon is whether anyone will license them, pay them, and let them stay in the room. Until it does, some person will lie down somewhere with someone sitting beside them, and everything will ride on whether that someone was ready. Before you say yes to anyone’s session, ask the one question the hearing could not answer: who, exactly, is sitting with me, and who trained them?

Until it does, some person will lie down somewhere with someone sitting beside them, and everything will ride on whether that someone was ready.