A bipartisan coalition of 32 members of Congress is urging federal health officials to expedite ongoing reviews of psychedelic therapies.
“For many individuals, current treatment options remain insufficient, deepening an already urgent public health crisis,” the lawmakers, led by Reps. Jack Bergman (R-MI) and Lou Correa (D-CA), co-chairs of the Congressional Psychedelics Advancing Therapies Caucus, wrote in a letter to the head of the Food and Drug Administration (FDA). “As Members of the House of Representatives, we have heard from countless Veterans, clinicians, and families seeking evidence-based alternatives.”
The letter to FDA Commissioner Marty Makary says lawmakers are “encouraged” by his recent statement that psychedelic treatments are “a top priority for this FDA and this administration.”
FDA and the Department of Health and Human Services (HHS) last month announced steps that they say will help with “accelerating” therapeutic access to psychedelics for patients dealing with serious mental health conditions.
That move followed a psychedelics executive order that President Donald Trump signed.
The lawmakers’ new letter said they want FDA to pursue “‘an expeditious and rapid review’ of promising treatments, especially those that address urgent unmet needs in PTSD, traumatic brain injury, and other neuropsychiatric conditions”—but they also “understand and respect the agency’s role in ensuring that any new treatment meets rigorous standards of safety and efficacy.”
They said that recent developments, including the public release of documents related to the rejection of approval for MDMA-assisted therapy during the Biden administration “highlight the complexity of evaluating innovative treatment modalities and underscore the need for clear, consistent expectations for this emerging field.”
The lawmakers have a number of questions they want Makary to answer:
- Special Protocol Assessment (SPA): How does the FDA communicate and apply any remaining data concerns beyond clearly defined primary endpoints and control conditions when pivotal trials are conducted under an SPA? Are improvements underway to make regulatory expectations more predictable for therapies in emerging fields?
- Methodological Standards and Interagency Coordination: What steps is the FDA taking to clarify methodological expectations for entactogen- and psychedelic-assisted clinical trials—including strategies to mitigate functional unblinding and expectancy effects—and how is the agency coordinating with federal partners such as the U.S. Department of Veterans Affairs to streamline research pathways for populations with urgent unmet needs, including Veterans with PTSD.
- Review Integrity and Subject-Matter Expertise: How does the FDA ensure that qualified experts with relevant experience conduct reviews of entactogen- and psychedelic-assisted therapies? What steps are in place to ensure consistency, objectivity, and independence in the evaluation process?
- Final Guidance Timeline: What is the expected timeline for finalizing the FDA’s June 2023 guidance on clinical trials involving rapid-acting novel therapeutics, including entactogen- and psychedelic-assisted therapies?
They are also encouraging FDA to provide clarity in any new guidance concerning:
- Strategies to mitigate functional unblinding and expectancy bias;
- Standards for adverse event monitoring and safety reporting;
- Provider training, licensing, and participant safeguards;
- The evolving role of psychotherapy in conjunction with pharmacological intervention;
- Generalizability of findings across diverse patient populations; and
- Consistency in regulatory expectations across entactogen and psychedelic drug development programs.
“We remain committed to ensuring that Veterans and others living with treatment-resistant mental health conditions have access to safe, evidence-based care,” the lawmakers wrote. “We respectfully urge the FDA to continue its evaluation of entactogen- and psychedelic-assisted therapies with transparency, urgency, and scientific rigor as the agency carries out its statutory responsibilities.”
In addition to Bergman and Correa, other lawmakers who signed the letter 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 recently that the Trump administration is “very anxious” to create a pathway for access to psychedelics therapy and that top officials across federal agencies want to “get it out to the public as quickly as possible.”
In an interview on the Joe Rogan Experience in February, Kennedy said he’s confident “we’re going to get it done,” with plans to develop and finalize rules that would enable patients with conditions such as post-traumatic stress disorder (PTSD) and depression to access psychedelic substances like psilocybin and MDMA in a “very controlled setting.”
“Everybody in my agency…is very anxious to get a rule out there that will allow these kind of studies and will allow access under therapeutic settings, particularly [for] the military soldiers who have suffered these injuries to get access to these products,” the HHS secretary said. “We’re working through that process now. We’re all working on it and trying to make it happen.”
“I think that we’re going to get it done,” he said.
Last June, Kennedy said his agency is “absolutely committed” to expanding research on the benefits of psychedelic therapy and, alongside of the head of FDA, is aiming to provide legal access to such substances for military veterans “within 12 months.”
Veterans Affairs Secretary Doug Collins also disclosed in April that he had an “eye-opening” talk with Kennedy about the therapeutic potential of psychedelic medicine. And he said he’s open to the idea of having the government provide vouchers to cover the costs of psychedelic therapy for veterans who receive services outside of VA as Congress considers pathways for access.
Bipartisan congressional lawmakers introduced legislation this session to provide $30 million in funding annually to establish psychedelic-focused “centers for excellence” at U.S. Department of Veterans Affairs (VA) facilities, where veterans could receive novel treatment involving substances like psilocybin, MDMA and ibogaine.
A U.S. Senate committee held a hearing last month on a bipartisan bill to promote research into the therapeutic potential psychedelics by creating a new office at VA that would advance the development innovative treatments for serious mental health conditions and assist in reviewing the scheduling status of drugs like psilocybin, ibogaine and MDMA.
Former U.S. House Speaker Newt Gingrich (R-GA) has said ibogaine represents an “astonishing breakthrough” in the nation’s current “sick care system” that’s left people with serious mental health conditions without access to promising alternative treatment options.
