HHS, VA sign agreement to advance psychedelic therapy

HHS and the Department of Veterans Affairs entered into a memorandum of understanding July 13 to bolster collaboration on the research, clinical development and deployment of potential future psychedelic drug products for veterans with serious mental health conditions if approved by the Food and Drug Administration, according to a July 13 news release from HHS.

Here are three things to know:

1. The agreement calls for the agencies to coordinate workforce training, develop evidence-based clinical protocols, support research and real-world evidence generation, and prepare the VA healthcare system to implement future FDA-approved rapid-acting psychiatric drug products.

2. Under the agreement, HHS and the VA will work to increase veteran participation in clinical research, train therapists, nurses, physicians and other clinicians, collect and share real-world data on safety, effectiveness and costs, coordinate research and evidence-sharing as appropriate and consistent with legal authority, and develop clinical guidance and educational resources for providers. The agreement remains in force for five years, with the option to renew.

3. The FDA and VA entered into a separate memorandum of understanding to expand information-sharing and scientific collaboration, while other HHS agencies announced related initiatives, according to the release. Those include Advanced Research Projects Agency for Health inviting applications to support ibogaine research for opioid use disorder and the Health Resources and Services Administration issuing a Request for Information on July 14 to gather input on preparing the healthcare workforce for potential future FDA-approved psychedelic drug products.

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