Reps. Jack Bergman and Lou Correa, co-chairs of the Congressional Psychedelics Advancing Therapies Caucus, led a bipartisan group of 30 colleagues in sending a letter to Food and Drug Administration Commissioner Martin A. Makary on May 6 urging faster evaluation of novel rapid-acting therapeutics for serious mental health conditions.
The lawmakers say that millions of Americans face complex mental health challenges for which current treatments are often inadequate. This problem is particularly acute among veterans, who experience higher rates of post-traumatic stress disorder (PTSD), depression, and suicide compared to the general population.
The letter follows an executive order signed by President Trump on April 18 that directs federal agencies to accelerate access to psychedelic treatments for patients with serious mental illnesses who have not found relief with existing options. In their message, the members write: “We write regarding the U.S. Food and Drug Administration’s (FDA) ongoing evaluation of rapid-acting novel therapeutics, including entactogen- and psychedelic-assisted therapies, for mental health conditions affecting millions of Americans. For many individuals, current treatment options remain insufficient, deepening an already urgent public health crisis.” They add: “We are encouraged by your public statements recognizing these treatments as ‘a top priority for this FDA and this administration.'”
The lawmakers ask the FDA about its processes regarding Special Protocol Assessment communication, methodological standards in clinical trials involving psychedelics or entactogens, review integrity measures ensuring qualified experts conduct evaluations, and the timeline for finalizing guidance on clinical trials involving these therapies. They also encourage clarity around mitigating bias in studies, safety monitoring standards, provider training requirements, psychotherapy’s role alongside drug interventions, applicability across diverse populations, and consistency in regulatory expectations.
“We remain committed to ensuring that Veterans and others living with treatment-resistant mental health conditions have access to safe evidence-based care,” they write. The letter concludes: “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.” Bergman has served in Congress representing Michigan’s 1st District since 2017 according to Wikipedia.
