Joseph McKay spent years in pain that wouldn’t quit. The retired New York City firefighter and 9/11 first responder dealt with cluster headaches so severe they ruled his life. PTSD made everything worse. He tried the treatments his doctors recommended. Nothing worked.
Then he tried something different: carefully supervised psilocybin sessions. His symptoms went into remission.
On September 30, McKay told his story to New York state lawmakers at the Assembly’s first public hearing on medical psilocybin. His testimony was one small part of a larger shift happening right now in psychedelic policy. The field isn’t dead after last year’s high-profile MDMA rejection. It’s changing, getting more careful, and in some ways more transparent than ever.
What the FDA actually said about MDMA
Here’s what most people missed in early September. The FDA doesn’t usually explain its drug rejections in public. When the agency says no, companies know why, but patients and researchers are left guessing.
That changed on September 4 when the FDA announced it would start releasing these rejection letters publicly. The agency posted a batch of past decisions, including the one that stopped MDMA therapy for PTSD.
The letter to Lykos Therapeutics spelled out three problems. First, people in the clinical trials could usually tell whether they got MDMA or a placebo. The drug has obvious effects. When you know what you’re taking, it’s hard to separate real benefits from expectations. Second, the safety data had holes. The FDA wanted better information about addiction risk and side effects. Third, researchers didn’t follow patients long enough to know if the improvements lasted.
None of this came out of nowhere. Back in June 2024, an FDA advisory committee voted nine to two against approval. They said the evidence didn’t prove the drug worked. Ten of eleven members said the benefits didn’t clearly outweigh the risks.
When the official rejection came in August, the agency told Lykos to run another major trial. MAPS responded by saying the nonprofit would keep supporting the research. Setbacks happen in science. The work continues.
New York lawmakers heard what conventional medicine can’t always fix
While federal regulators applied stricter standards, state legislators explored a different question: what happens when standard treatments fail people?
The New York hearing in Manhattan went on for hours. Doctors, researchers, patients, and advocates all weighed in. McKay’s story stood out, but he wasn’t alone. Other patients described years of treatment-resistant depression, anxiety that wouldn’t respond to medication, conditions that left them desperate for anything that might help.
Some witnesses urged caution. Limited long-term data means real unknowns about side effects and risks. Moving too fast could hurt people.
Assembly Health Chair Amy Paulin said afterward that psilocybin shows real promise for conditions that don’t respond to conventional care. But any legislation needs strong safety measures from day one.
Two basic models are on the table. One would let patients buy limited amounts after passing a health screening. The other would license trained guides who supervise sessions in controlled settings. New York hasn’t decided which path makes sense yet.
Three states already tried three different approaches
If New York moves forward, it won’t be starting from scratch. Three states already built psilocybin programs, each with a different philosophy.
Oregon launched the first regulated program in 2023. Any adult over 21 can book a supervised session at a licensed center. No diagnosis required. No prescription needed. Oregon treats it more like a wellness service than medical treatment.
Colorado followed a similar path and started licensing facilitators this year. Both states emphasize safe settings and trained guides rather than doctor involvement.
New Mexico went a completely different direction. The state passed a Medical Psilocybin Act in April 2025 that creates a true medical program where clinicians diagnose and supervise treatment. State health officials are writing the rules now. Full implementation should happen by late 2027.
Each state is essentially running its own experiment. The results will tell us a lot about what works and what doesn’t.
What happens from here
Three things are moving forward at the same time.
Better science is coming. The FDA’s new transparency policy shows researchers exactly what went wrong with MDMA. Future trials can address those specific problems: study designs that account for people knowing what drug they took, safety monitoring that captures complete information, follow-up periods long enough to measure whether benefits last.
Other psychedelic compounds are still in clinical trials. Psilocybin therapies for depression haven’t reached FDA review yet. When they do, they’ll face the same rigorous standards MDMA couldn’t meet.
State programs are moving from theory to practice. Oregon and Colorado are building their service systems. New Mexico is drafting medical protocols. New York is deciding what makes sense for the nation’s biggest media market. Everyone is figuring out the practical stuff: costs, training requirements, who gets access, how to keep people safe.
Watch these three developments:
Clinical trial designs that directly tackle the problems FDA identified. How do you run a blind study when the drug has obvious effects? How long do you need to follow patients to prove benefits last?
New York’s legislative process. Will lawmakers go with a medical model like New Mexico or a services model like Oregon? The state’s decision could influence what other large states do next.
Real-world results from existing programs. Oregon and Colorado data on safety, outcomes, and who actually uses these services. New Mexico’s medical program once it launches.
Why this matters beyond policy debates
For people like Joseph McKay, this isn’t an abstract policy question. It’s about whether they can access treatment that might actually help when everything else has failed.
Standard psychiatric care works for many people. But not everyone. Treatment-resistant depression is real. PTSD that doesn’t respond to therapy is real. Cluster headaches that destroy quality of life are real.
The FDA’s detailed rejection letter showed how high the bar is for approval. That’s probably good. We need rigorous evidence. But New York’s hearing showed something else: lawmakers trying to figure out how to help people who are suffering right now while still being responsible about safety and evidence.
Psychedelic policy is moving forward. It’s just doing it more carefully, more transparently, and with clearer standards than before. Whether this leads to FDA-approved treatments or just better state programs, we’ll find out in the next few years.
What’s certain is that the conversation isn’t over. It’s just getting more serious.
Works Cited
- FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89. U.S. Food & Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-announces-real-time-release-complete-response-letters-posts-previously-unpublished-batch-89
- FDA Releases CRL Detailing Safety Concerns for MDMA-Assisted Therapy in PTSD. HCPLive. https://www.hcplive.com/view/fda-releases-crl-detailing-safety-concerns-mdma-assisted-therapy-ptsd
- FDA Advisors Recommend Against Using MDMA for PTSD Treatment. TIME. https://time.com/6985929/fda-advisors-reject-mdma-ptsd-treatment/
- MAPS Statement on FDA’s Public Release of Complete Response Letter for MDMA-assisted Therapy. MAPS. https://maps.org/2025/09/04/fda-public-release-of-crl/
- Medicinal value of psilocybin — Public Hearing Notice. New York State Assembly. https://nyassembly.gov/write/upload/publichearing/20250910.pdf
- New York state already legalized marijuana. Could magic mushrooms be next? Gothamist. https://gothamist.com/news/new-york-state-already-legalized-marijuana-could-magic-mushrooms-be-next
- New York lawmakers consider psychedelic psilocybin for medicinal purposes. Times Union. https://www.timesunion.com/state/article/new-york-lawmakers-considering-legalizing-21074747.php
- Oregon Psilocybin Services. Oregon Health Authority. https://www.oregon.gov/oha/ph/preventionwellness/pages/oregon-psilocybin-services.aspx
- Medical Psilocybin Program. New Mexico Department of Health. https://www.nmhealth.org/about/mcpp/mpp/
- US FDA declines to approve first MDMA-based PTSD treatment. Reuters. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-declines-approve-first-mdma-based-ptsd-treatment-2024-08-09/