Advancing psychedelic therapies for mental health

    Several Department of Health and Human Services (HHS) agencies and the Department of Veterans Affairs (VA) are taking steps to advance the development of psychedelic therapies for mental illness.

    • Reminder: President Trump previously issued an executive order that called on agencies to do this.

    The details:

    • HHS and the VA entered into a Memorandum of Understanding (MOU) to coordinate workforce training, develop clinical protocols, support research, and prepare the VA health care system to implement future products approved by the Food and Drug Administration (FDA).
    • FDA and the VA are entering into an MOU to expand information-sharing and scientific collaboration to advance the development and evaluation of innovative therapies for serious mental illness. FDA issued industry guidance for sponsors developing psychedelic drugs and announced a public hearing on the potential future therapeutic use of psychedelics.
    • The National Institute on Drug Abuse (NIDA) has awarded funding for a research project to support an Investigational New Drug application to FDA for ibogaine.
    • The Advanced Research Projects Agency for Health (ARPA-H) is offering funding to advance research on ibogaine as a potential treatment for opioid use disorder. Funding will support clinical development and preparation for FDA review and explore ways to keep future treatments affordable and accessible.
    • The Health Resources and Services Administration (HRSA) issued a Request for Information on how the health care system should prepare for future FDA-approved psychedelic drugs (e.g., clinician education/training, care delivery models).

    Read more: HHS & VA Announce Bold, Comprehensive Partnership to Advance Rapid-Acting Mental Health Treatments for Veterans