we respectfully urge the FDA to continue its evaluation of entactogen- and psychedelic-assisted therapies with transparency, urgency, and scientific rigor
Urge the FDA to expedite and continue evaluating rapid-acting novel therapeutics, including entactogen- and psychedelic-assisted therapies, for serious mental health conditions.
Occurrences
Reps. Jack Bergman and Lou Correa, co-chairs of the Congressional Psychedelics Advancing Therapies Caucus, led 30 bipartisan colleagues in sending a letter to Food and Drug Administration (FDA) Commissioner Martin A. Makary urging the agency to advance its evaluation of rapid-acting novel therapeutics – including entactogen- and psychedelic-assisted therapies – for the
Evidence
On May 6, 2026, Bergman’s office said Bergman and Correa led 30 bipartisan colleagues in sending a letter to FDA Commissioner Martin A. Makary urging the agency to advance its evaluation of rapid-acting novel therapeutics, including entactogen- and psychedelic-assisted therapies, for serious mental health conditions. The letter asks for written responses on FDA methodology, review expertise, and the timeline for finalizing the June 2023 psychedelic-drugs guidance.
FDA announced it was accelerating research, approval, and responsible access to promising mental health treatments, prioritizing therapies with Breakthrough Therapy designation and issuing national priority vouchers for psilocybin for treatment-resistant depression, psilocybin for major depressive disorder, and methylone for PTSD. FDA also said it intended to release final guidance imminently for sponsors developing these products.
Bergman and Correa led 30 bipartisan House members in a letter to FDA Commissioner Martin A. Makary urging the agency to advance evaluation of rapid-acting novel therapeutics, including entactogen- and psychedelic-assisted therapies, and asking for the timeline to finalize the June 2023 guidance.
The FDA announced priority vouchers for psilocybin studies, allowed an early phase noribogaine study to move forward, and said it intended to release final guidance imminently for sponsors developing these products.
Rep. Jack Bergman's office announced that Bergman and Rep. Lou Correa led 30 bipartisan House colleagues in a letter to FDA Commissioner Martin A. Makary urging FDA to advance evaluation of rapid-acting novel therapeutics, including entactogen- and psychedelic-assisted therapies, for serious mental health conditions. The release reproduces the letter asking about FDA methodology, review expertise, interagency coordination, and timing for final guidance.
The signed congressional letter begins by addressing FDA's ongoing evaluation of rapid-acting novel therapeutics, including entactogen- and psychedelic-assisted therapies. It states agreement that FDA should conduct expeditious and rapid review for promising treatments addressing urgent unmet needs, asks when FDA will finalize its June 2023 guidance, and closes by urging FDA to continue evaluation with transparency, urgency, and scientific rigor. Jack Bergman is listed as a signer.
FDA announced regulatory actions supporting development of serotonin-2A agonists and related psychedelic products, including priority vouchers for psilocybin and methylone studies, an allowed early phase noribogaine clinical study, continued data review, and imminent final guidance for sponsors developing these products.
Executive Order 14401 states a policy to accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs for serious mental illness. It directs FDA review prioritization for appropriate psychedelic drugs with Breakthrough Therapy designation and calls for HHS, FDA, and VA collaboration to facilitate timely evaluation and approval where statutory standards are met.
Assessments
The promise was specifically to urge the FDA, not to guarantee final FDA approval or guidance. During Bergman’s current House term, he led a bipartisan May 2026 congressional letter to FDA Commissioner Martin Makary urging expedited and continued evaluation of rapid-acting novel therapeutics, including entactogen- and psychedelic-assisted therapies, for serious mental health conditions. That directly satisfies the promised oversight action in the federal office context.
Bergman did the promised oversight action in May 2026 by leading a bipartisan letter urging the FDA to expedite and continue evaluating these therapies and to finalize guidance. That satisfies the promise as an advocacy/pressure action in office; the FDA's separate acceleration later supports the policy direction but is not needed for credit.
Bergman clearly acted on the promise by co-leading a bipartisan May 2026 letter urging the FDA to expedite review and continue evaluating rapid-acting novel therapeutics, including psychedelic-assisted therapies. That satisfies meaningful oversight effort. There is also evidence the FDA, in April 2026, accelerated action on such treatments and planned final guidance, which aligns with the promised objective. However, the available evidence does not show Bergman personally caused or secured the FDA action, and much of the outcome appears to have been agency-driven following an executive order rather than directly attributable to him. Because there was real advocacy and some aligned agency movement, but not enough proof of full candidate-delivered fulfillment, the best judgment is partial.