Thirty-two bipartisan House members have written to FDA Commissioner Marty Makary—who called psychedelic treatments "a top priority for this FDA and this administration"—urging faster review. Led by Reps. Jack Bergman (R-MI) and Lou Correa (D-CA), co-chairs of the Congressional Psychedelics Advancing Therapies Caucus, the effort follows FDA and HHS actions last month to accelerate psychedelic access and an executive order signed by President Donald Trump.
"For many individuals, current treatment options remain insufficient, deepening an already urgent public health crisis," the lawmakers wrote. "As Members of the House of Representatives, we have heard from countless Veterans, clinicians, and families seeking evidence-based alternatives."
The letter requests "an expeditious and rapid review" for treatments targeting PTSD, traumatic brain injury, and neuropsychiatric conditions, while acknowledging FDA's safety and efficacy role. It references Biden-era documents on the rejection of MDMA-assisted therapy as evidence of regulatory complexity in the field.
The lawmakers ask Makary four questions: how FDA communicates data concerns beyond primary endpoints in a Special Protocol Assessment; steps to clarify methodological standards and coordinate with VA on veteran populations; how reviewer expertise and consistency are ensured; and when the June 2023 guidance on rapid-acting novel therapeutics will be finalized.
They also seek FDA guidance on functional unblinding and expectancy bias, adverse event monitoring, provider training and participant safeguards, psychotherapy's role alongside drug treatment, population generalizability, and cross-program regulatory consistency.
Other signatories include Reps. Dan Crenshaw (R-TX), Morgan Luttrell (R-TX), Pete Sessions (R-TX), Alexandria Ocasio-Cortez (D-NY), Nancy Mace (R-SC), Mark Pocan (D-WI), Mariannette Miller-Meeks (R-IA), and Derrick Van Orden (R-WI).
HHS Secretary Robert F. Kennedy Jr. said on the Joe Rogan Experience in February that the administration is eager to establish a psychedelic therapy access framework. Last June, he said his agency is "absolutely committed" to expanding psychedelic research and aims to provide veterans legal access within 12 months.
VA Secretary Doug Collins said in April that an "eye-opening" talk with Kennedy made him open to government vouchers for veterans seeking psychedelic therapy outside VA. Bipartisan legislation this session would allocate $30 million annually for psychedelic-focused "centers for excellence" at VA facilities offering psilocybin, MDMA, and ibogaine. A Senate committee held a hearing last month on a separate bipartisan bill to create a new VA office advancing these treatments and reviewing the scheduling of psilocybin, ibogaine, and MDMA. Former House Speaker Newt Gingrich (R-GA) has called ibogaine an "astonishing breakthrough."
