Washington DC — Reps. Jack Bergman (R-MI) and Lou Correa (D-CA), co-chairs of the Congressional Psychedelics Advancing Therapies Caucus, led a bipartisan group of 30 members of Congress in a letter to Food and Drug Administration (FDA) Commissioner Martin A. Makary, urging the agency to advance evaluation of psychedelic-assisted therapies. The letter asks FDA to respond to a series of questions at the center of the evaluation of MDMA-assisted therapy for PTSD that MAPS originated and advanced for more than two decades.
MAPS Founder and President Rick Doblin, Ph.D., issued the following statement:
The congressional letter to FDA Commissioner Marty Makary is a tremendous sign of support from over 30 members of Congress to expedite psychedelic drug development through the FDA. The letter asks FDA to respond to a series of questions, starting with explaining how the Special Protocol Assessment (SPA) process can be made more predictable. MAPS extensively discussed functional unblinding with the FDA during the 2017 SPA process and adopted in the Phase 3 studies the methodological approach required by the FDA, only in 2024 to have the FDA Advisory Committee and the FDA question that approach and base much of their rejections on concerns about functional unblinding.
The Congressional letter also asks FDA to explain how it intends to obtain qualified experts on its Advisory Committees. Numerous people on the FDA advisory committee reviewing and rejecting the Lykos NDA said they were not subject matter experts.
I was especially encouraged by the section asking the FDA to respond to “The evolving role of psychotherapy in conjunction with pharmacological intervention.” That question gets to the heart of a major divide emerging in the field. Sadly, many psychedelic pharmaceutical companies appear to be engaged in a race to the bottom, seeking a Minimal Viable Product (MVP) designed to minimize or eliminate therapy and therapists as much as possible, rather than striving to maximize therapeutic outcomes. In part this is because the FDA doesn’t understand or regulate therapy so companies think that eliminating or minimizing therapy is the easiest path to approval.
MAPS has consistently taken the opposite approach, emphasizing the importance of therapy as an integral component of treatment, including the training of therapists through legal, optional, and strongly encouraged self-experiences. This Congressional letter is most welcome, wisely written, and likely to be very helpful.
ABOUT MAPS
Founded in 1986, MAPS is a 501(c)(3) nonprofit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful use of psychedelics and marijuana. MAPS previously sponsored the most advanced psychedelic-assisted therapy research in the world and continues to support psychedelic and marijuana research with a focus on the people and places most impacted by trauma. MAPS incubated Lykos Therapeutics, a drug-development public benefit company, and The Zendo Project, a leader in psychedelic harm reduction. Since MAPS was founded, philanthropic donors and grantors have given more than $150 million to advance psychedelic research, change drug policy, and shape culture.