Yesterday, a letter from the U.S. Department of Health and Human Services was made public describing the Food and Drug Administration’s “anticipated approval…within approximately 24 months” of psychedelic-assisted therapies. The letter indicated that the Substance Abuse and Mental Health Services Administration is exploring establishment of a Federal Task Force to address the complex issues associated with the commercialization of psychedelic medicines, including clinical, regulatory, and public policy matters.
We applaud the Biden Administration for taking psychedelic-assisted therapies, and their potential to treat life-threatening mental health conditions, seriously. A Federal Task Force on psychedelic-assisted therapies should take a multidisciplinary approach to ensuring that red tape, administrative delays, or insurance coverage questions don’t leave Americans suffering as they seek to access approved treatments.
Rick Doblin, Ph.D., Founder and Executive Director, MAPS
For the first time, research that has been driven by philanthropists could additionally be supported by the same types of Federal grants that have funded other health care revolutions and develop patient access strategies that prioritize public benefit over profit. For decades, we have been making the case for what the Administration is now acknowledging: psychedelic-assisted therapies may become a key in addressing the most urgent mental health challenges of our time and reducing needless suffering.
The safety and efficacy of MDMA-assisted therapy is currently under investigation. It has not yet been approved by the FDA or other regulatory authorities, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future regulatory approval or availability of MDMA-assisted therapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from our projections.
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS is sponsoring the most advanced psychedelic therapy research in the world: Phase 3 clinical trials of MDMA-assisted therapy for PTSD. Since MAPS was founded, philanthropic donors and grantors have given more than $130 million for psychedelic and marijuana research and education. MAPS has earned both the Guidestar Platinum Seal of Transparency and a 4-Star Rating from Charity Navigator.