A veteran’s recovery from 10-out-of-10 pain shows what the agency’s psychiatric model misses, and why your experience belongs in the record.
In 2003, a belt strapped wrong across Lynn Watkins’s hips during shoulder surgery cut a nerve in her right leg. The injury spread into full-body complex regional pain syndrome (CRPS, a disorder that keeps pain signals firing long after an injury). For years she lived at pain level 10, “each day, every day.”
Watkins served 25 years in the Air Force, including as a JAG officer and military trial judge. On September 14 she told an FDA hearing that in 2023, after standard care failed, she took psilocybin with physical therapy and neuromodulation during the session. Her pain fell to nearly zero and stayed there. “Within 90 minutes of dosing,” she said, “I stretched out my right foot, and all five toes moved for the first time in nine years.”
One recovery is not a trial, and hers is a single published case report. But note what she credited: the physical therapy in the room. Without it, she said, her healing “would’ve been significantly limited.” That is not psychiatric care, and the federal plan makes little room for it.
The FDA is now deciding how psychedelic care will work once these drugs are approved. It takes public comments until 11:59 p.m. Eastern on Monday, October 5. Only a few hundred people have commented so far. I want thousands, from people who know what the agency doesn’t. This is a really big deal. Rules like these are hard to change once set.
Short on time? Pick a topic below, write a few paragraphs on what you’ve seen, and file it here. Ten minutes is enough.
What the FDA is asking
The notice covers psychedelic drugs “in supervised and supportive settings,” under four topics:
- Training and credentialing: who belongs in the session room, with what training.
- Patient safety: screening, consent, monitoring and misconduct, including touch and the power gap between patient and provider.
- Access: insurance, staffing, clinic capacity, telehealth.
- Data: what to track, how to define an adverse event (a harmful or unwanted effect), and how to follow patients.
FDA says comments on scheduling, legalization, religious use or specific practitioners “may not be considered.” I care about those issues, but this isn’t the venue. Written comments count the same as testimony at the hearing.
Pain is missing from the frame
FDA’s process grows out of Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illness.” It names depression, addiction and suicide. It never mentions pain.
The hearing notice follows suit. It asks about counselors and peer support specialists, and about screening for psychosis and suicidality. FDA’s July trial guidance wants a lead monitor trained in psychotherapy. That fits depression. It fits a cut nerve less well.
Pain is no niche. In 2023, 24.3% of U.S. adults had chronic pain, the CDC found, and 8.5%, about one in 12, had pain that often limited their life or work. Musculoskeletal disorders (the back, spine and joints) are the largest diagnosis group among workers on Social Security disability, at 34.1%. Migraine is the leading cause of years lived with disability for people 15 to 49 worldwide.
Every person pain keeps from work is a lost paycheck and often a disability check. A treatment that returns some of them to work saves public money.
Only a handful of the roughly 80 speakers at the hearing put pain first. Richard Langford, chief medical officer of PsyBio Pharma, noted that pain clinics already give ketamine infusions and employ psychologists. He asked FDA to look “beyond the psychiatric setting.”
A handful of voices in four hours. The written record has to do better.
How a narrow model locks people out
FDA’s caution has good reasons. Ibogaine can disrupt the heart’s rhythm, and a speaker told the panel no one yet knows how to predict that risk in a given patient. Psilocybin and MDMA raise heart rate and blood pressure modestly for a few hours, which screening can manage. Their bigger risks are psychological, including suggestibility and the misconduct several speakers raised. For the first approvals, in depression and PTSD, supervised settings are a sound start. I’d start there too.
The question is not whether supervision belongs in psychedelic care. The question is whether one model should fit every patient. Three details worry me.
The label. FDA’s guidance says the treatment model a sponsor tests “may be described in product labeling.” If every trial pairs the drug with psychotherapy, the label may require it. A phantom limb patient may need a physical therapist far more than psychotherapy.
The 15-minute rule. The guidance wants an on-call physician within 15 minutes when the lead monitor isn’t one. John Dalton, a retired Navy SEAL who leads the Nevada Coalition for Psychedelic Medicines, told the panel that nearly 87% of Nevadans live in a mental health shortage area. The rule, he said, “could exclude otherwise qualified clinics.”
The template. Compass Pathways, furthest along with psilocybin, plans to launch through some 8,500 clinics delivering Spravato (esketamine). Its product “slots directly into the way these centers operate today,” chief patient officer Steve Levine told BioPharma Dive. Spravato’s REMS (the restrictions FDA can attach to a drug) requires a certified clinic, at least two hours of observation and no home use. It was built for depression, not migraine.
So here is my line. For some patients and conditions, at-home dosing should be on the table, settled between physician and patient. That cuts against FDA’s framing, and I say so openly. An every few days regimen doesn’t fit an allday clinic visit. Neither does a rural veteran three hours from a certified site. Christian Reed, a retired Green Beret speaking for the at-home ketamine company Mindbloom, told the panel that “the ability to do this at home was one of the only reasons we would consider it at all.”
Research on neurodegenerative disease, stroke and spinal cord injury is early. But doctors can usually prescribe approved drugs off-label unless a REMS forbids it. Rules written for depression shouldn’t block that research and its use in a clinic before it starts.
Find your comment
You don’t need a thesis. You need one thing you know from experience. Some prompts:
- Training: What did your training miss? Who on your team does work no credential captures?
- Safety: What warning sign do you catch that a checklist would miss? What should every patient hear before consenting?
- Access: Who near you can’t reach a clinic? Have you seen care stall over billing?
- Data: What harm, or benefit, would current reporting miss? How long do effects last, and who tracks it?
If you live with or treat chronic pain, say so, and describe the care you’d need. Almost nobody has.
One real experience beats a page of opinion. Leave out anything that could identify a patient.
How to file
- Where: regulations.gov, docket FDA-2026-N-7542
- Deadline: 11:59 p.m. Eastern, Monday, October 5, 2026
- Length: 5,000 characters, or attach a file
- Public: Your name is posted. Keep private details out.
- Scope: Training, safety, access, data. Not scheduling or legalization.
Disclosure: I’m a founding board member of the Psychedelics and Pain Association, which Watkins credits in her testimony. Psychedelics Today runs Vital, a training program for clinicians. I wrote about her testimony in September, after a wire story pinned another speaker’s quote on her.
These rules are being written before the first approval. The people who know and care about psychedelic work belong in them. I’m filing mine, mostly about pain. Write yours about what you know best, by Monday night. Let’s get to work.
