The Department of Health and Human Services (HHS) and Department of Veterans Affairs (VA) signed a memorandum of understanding on Monday to jointly pursue research and development of psychedelic medicines for serious mental health conditions, building on President Donald Trump's earlier executive order directing agencies to speed up psychedelics research.
HHS Secretary Robert F. Kennedy, Jr. said in a statement, “America owes every veteran the best care our nation can provide. We’re not going to wait while promising treatments sit on the sidelines. Thanks to President Trump’s leadership, HHS and the VA are working together to develop safe, FDA-approved innovations and transition them from research into care so veterans can access the treatments they deserve.”
VA Secretary Doug Collins said the agreement would help “turn research into life-changing treatment.”
The five-year agreement commits the departments to expanding veteran participation in clinical trials of rapid-acting mental health treatments, training clinicians to administer future FDA-approved therapies, collecting real-world data on safety, cost and effectiveness, coordinating evidence-sharing to inform FDA regulatory and coverage decisions, and developing clinical guidance for providers.
A second MOU signed the same day pairs VA with the Food and Drug Administration (FDA) to share information and scientific expertise on psychedelic drug development. FDA Acting Commissioner Kyle Diamantas said the pact would help “speed the development and review of promising therapies while maintaining our rigorous standards for safety and effectiveness.”
Separately, the National Institute on Drug Abuse is awarding $2.3 million toward an investigational new drug application for ibogaine, while HHS’s Advanced Research Projects Agency for Health (ARPA-H) is funding additional ibogaine research targeting opioid use disorder. NIH Director Jay Bhattacharya and ARPA-H Director Alicia Jackson both endorsed the efforts. HHS’s Health Resources and Services Administration also opened a request for information on preparing the healthcare workforce for approved psychedelic treatments, according to Administrator Tom Engels.
FDA additionally finalized guidance Monday on the “unique challenges” of psychedelic clinical research and scheduled a public hearing on the topic for September.
The moves follow an April announcement by FDA and HHS on accelerating psychedelics access, and a May letter from 32 bipartisan members of Congress urging FDA to speed its reviews. Lawmakers this month also introduced a bill requiring the Department of Defense to report on psilocybin’s potential military benefits, a separate bipartisan bill to codify Trump’s executive order into law, and a pending National Defense Authorization Act amendment extending DOD’s psychedelics research program six more years.
