- MAPS calls on HHS and FDA to prioritize science, compassion, and urgent regulatory reform to address PTSD affecting millions worldwide
- Despite successful Phase 3 trials, MDMA-assisted therapy remains out of reach — MAPS urges decisive federal leadership to save lives and help those suffering
WASHINGTON, DC (August 14, 2025) — One year after the FDA’s denial of the New Drug Application for MDMA-assisted therapy for PTSD, the Multidisciplinary Association for Psychedelic Studies (MAPS) has issued an open letter to the U.S. Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr., and Dr. Martin A. Makary, the Commissioner of the Food and Drug Administration (FDA), calling for urgent federal action. Despite successful Phase 3 clinical trials and broad bipartisan support, MDMA-assisted therapy for PTSD remains inaccessible to those who need it most. Millions are living with treatment-resistant trauma, and MAPS urges Secretary Kennedy and Commissioner Makary to take action to help make this modality legal and accessible.
Robert F. Kennedy Jr.
U.S. Secretary of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dr. Martin A. Makary
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
Dear Secretary Kennedy and Commissioner Makary,
One year ago, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter rejecting the New Drug Application for MDMA-assisted therapy for PTSD — a treatment born of decades of methodical research and relentless advocacy. The Multidisciplinary Association for Psychedelic Studies (MAPS) built the foundation for the research that Lykos Therapeutics brought into the final stages of FDA review, and it remains committed to this life-saving advocacy.
We remain hopeful that this promising modality will receive FDA approval in the near future, and we are encouraged by last month’s statements indicating that your offices understand the importance of making this a priority. Nonetheless, last year’s decision cost lives by delaying access to a treatment that may be a lifeline for the millions of Americans suffering from trauma disorders that conventional treatments often fail to treat — despite statistical significance and demonstrated efficacy found in clinical trials designed in collaboration with world-class experts from the Veterans Administration (VA) and renowned academic institutions including NYU, Harvard, and UCSF.
We understand the urgent need to mitigate and alleviate the substance misuse, mental health, and homelessness increasingly visible on American streets, but we cannot arrest our way out of this crisis. These symptoms — merely the most visible ones — often cascade from unresolved psychological distress. Psychedelics are not a panacea, but MDMA’s potential to treat the root causes of PTSD is exceptionally promising in the context of the social and fiscal burden of the compounded downstream effects of trauma.
To make matters worse, President Trump’s recent executive order (“Ending Crime and Disorder on America’s Streets“) further criminalizes vulnerable people suffering from substance use disorders — people with some of the highest rates of trauma. It draws arbitrary lines between people deserving and undeserving of compassionate care and keeps people in a cycle that your agencies claim to want to interrupt.
We recognize the complexity of assessing a modality that combines therapy with a drug, especially one that is currently listed in Schedule I, but PTSD is a public health emergency that will require innovation to interrupt. This illness impacts Veterans, survivors of sexual violence, first responders, and countless families and communities plagued by intergenerational trauma. Millions suffer in silence in prisons, reservations, and underresourced clinics, and every day of inaction represents dozens of lives lost to suicide.
This is not a partisan issue, and you will not stand alone. The VA, bipartisan members of Congress, MAPS, and dozens of nonprofit and professional organizations are ready to contribute to ensuring psychedelic medicine is implemented responsibly. Oregon and Colorado are pursuing regulatory access, sparking novel research, and collecting essential data at the state level, soon to be joined by New Mexico and Texas. Their bold leadership should not only benefit the people inside those state borders — the federal government can and should encourage and incorporate these innovations.
Advancing responsible access to psychedelic substances goes beyond political partisanship. Indigenous and faith-based communities are reasserting and weaving together healing traditions with scientific research. Veterans, first responders, physicians, and parents are speaking up for accurate education, a resourced safety net, and public health. Despite last year’s decision, the movement has not paused — it has diversified and deepened. We are not asking for special treatment. We are asking for science to be honored and lives to be saved.
MAPS and our colleagues across the movement are ready to work with you to create legal access to these promising modalities. Let this anniversary mark a turning point: we cannot undo the past year of delay, but together, we can ensure that the next one makes up for it.
With respect and resolve,
Betty Aldworth
Interim Co-Executive Director
Ismail L. Ali, J.D.
Interim Co-Executive Director
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 uses of psychedelics and marijuana. MAPS’ conference flagship, Psychedelic Science, has been the leading convening of the psychedelic community since 2010. 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 research, change drug policy, and evolve education in the field of psychedelics.