Lawmakers Push FDA to Speed Up Psychedelic Therapy Reviews
A bipartisan coalition of lawmakers is urging the U.S. Food and Drug Administration to accelerate its review of psychedelic therapies. On May 1, 32 House Republicans and Democrats sent a letter to FDA Commissioner Martin Makary. They asked the agency to advance evaluations of rapid acting therapeutics for PTSD, traumatic brain injury and related conditions. Reps. Jack Bergman and Lou Correa, who lead the Congressional Psychedelics Advancing Therapies Caucus, initiated the effort.
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| Key Takeaway | Details |
|---|---|
| Who signed | 32 House Republicans and Democrats |
| Recipient | FDA Commissioner Martin Makary |
| Date sent | May 1, 2026 |
| Conditions named | PTSD, TBI, neuropsychiatric disorders |
| Treatments referenced | Ibogaine, psilocybin, ketamine, LSD, MDMA |
| Executive order | Signed by President Trump in April 2026 |
| Companion bills | Innovative Therapies Centers of Excellence Act; Senate Bill 4220 |
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Inside the Letter
The letter poses four central questions to Makary. Lawmakers want clarity on how the FDA handles Special Protocol Assessments when pivotal trials move forward. They also seek answers on methodological standards for entactogen and psychedelic clinical research.
The signers asked how the agency coordinates with the Department of Veterans Affairs. They want streamlined research pathways for populations facing urgent unmet needs. They also requested a timeline for finalizing the FDA’s June 2023 guidance on rapid acting novel therapeutics. A fourth question addresses whether qualified experts can review these therapies with consistency and independence.
A Broader Legislative Push
This letter sits inside a wider campaign on Capitol Hill. Sen. Ruben Gallego, a Marine Corps veteran, has proposed the Innovative Therapies Centers of Excellence Act of 2025. The bill would designate at least five VA medical facilities to offer psychedelic therapies.
Sen. Tim Sheehy, a Navy SEAL veteran, introduced Senate Bill 4220 in March. That measure prepares the Veterans Health Administration for FDA approved psychedelic treatments. President Trump’s April executive order amplified the moment. It directed the FDA to facilitate access to ibogaine, psilocybin, ketamine, LSD and MDMA. Eligible patients with major depressive disorder or substance use disorders could benefit.
What This Means for Patients
Juliana Mercer, executive director of Healing Breakthrough and a Marine Corps veteran, called the bipartisan letter significant. She also stressed that speed cannot mean recklessness. No one is asking the FDA to lower the bar, she said.
The stakes feel urgent for veterans, who face elevated rates of suicide, depression and PTSD. For patients exploring ketamine clinics today or future MDMA programs, the regulatory landscape matters. The signals from Washington suggest the door may open wider in the months ahead.
