The Departments of Health and Human Services (HHS) and Veterans Affairs (VA) have entered a five‑year Memorandum of Understanding (MOU) to coordinate on rapid‑acting treatments for substance use disorders and mental health conditions in veterans, including psychedelic drug products.
In parallel, the HHS/FDA and VA have signed MOU 225‑26‑007, which lays out how the agencies will collaborate and share information to accelerate action on treatments aligned with two recent executive orders on serious mental illness and addiction. The document calls out psychedelic drugs as one example of potential treatments that may be informed by shared clinical trial data, safety information, and real‑world evidence.
Together, these steps are about creating a durable structure for how high‑risk, high‑impact psychiatric therapies are evaluated, regulated, and potentially delivered to veterans at scale.
What the HHS-VA and FDA-VA MOU Actually Does
Public statements from HHS and VA describe a partnership to prepare the VA health system for rapid‑acting mental health treatments, with a special focus on veterans living with PTSD, depression, suicidality, and substance use disorders. Key elements include:
- Increasing veteran participation in clinical trials for promising rapid‑acting treatments, including psychedelic‑assisted therapies
- Training clinicians across the VA system to administer new therapies safely if approved by FDA
- Developing educational materials so veterans understand potential benefits, risks, and care pathways
- Collecting and sharing data on safety, effectiveness, and costs to inform care, policy, and future coverage decisions
MOU 225‑26‑007 provides the specific framework for how FDA and VA will share information to support those goals. The agencies commit to:
- Coordinate on information needs related to substance use disorder and mental health conditions
- Share clinical trial data, safety reports, and real‑world data where permitted by law
- Use that information for operational decision support, surveillance of emerging public health concerns, and review of treatments, including potential psychedelic therapies
The MOU is careful on privacy and confidentiality. It emphasizes that each disclosure must be independently authorized under existing statutes and regulations, and that sensitive data – including trade secrets, confidential commercial information, and protected patient information – remains subject to strict safeguards. The sharing of identifiable patient information and national security information is explicitly not contemplated here.
ARPA-H’s Involvement
The Advanced Research Projects Agency for Health (ARPA‑H) is also being drawn into this policy effort through Executive Order 14401: Accelerating Medical Treatments for Serious Mental Illness, including psychoplastogen therapeutics such as ibogaine.
Under a recent Special Notice (SN-26-156) tied to its Proactive Health Office (PHO) Innovative Solutions Opening (ISO) (PHO-SOL-24-106), ARPA‑H is soliciting solution summaries for early clinical development of ibogaine for opioid use disorder (OUD). The notice focuses on plans to develop and submit an Investigational New Drug (IND) application, design safe Phase 1 protocols with cardiotoxicity risk‑mitigation, and secure GMP‑grade ibogaine with the necessary Chemistry, Manufacturing, and Control (CMC) work for a Schedule I substance.
For more context on the funding opportunity, what ARPA-H is looking for, and how to apply to SN-26-156, see our related piece here.
How the Pieces Fit Together
Viewed together, the HHS–VA partnership, the FDA–VA MOU, and the ARPA‑H Special Notice outline a division of labor across the federal system:
- ARPA‑H focuses on high‑risk development for psychoplastogens like ibogaine, including early clinical work and regulatory strategy for serious mental illness and OUD.
- FDA and HHS focus on regulatory standards, safety and efficacy review, and the broader framework for rapid‑acting psychiatric treatments, including psychedelic drug products
- VA prepares its care delivery and data infrastructure – clinician training, patient education, trial participation, and real‑world evidence generation – for potential future deployment of approved therapies to veterans.
Multiscale coordination like this is rare in mental health. If carried through, it could reduce the long gap between scientific promises and practical care for veterans by aligning R&D, regulation, and health system implementation from the outset.
Where This Leaves Developers
For developers in mental health, neuropsychiatry, and addiction treatment, the message is that the federal government is building a more structured path for bringing high‑risk interventions into large health systems. That path will expect:
- Serious plans for evidence generation, including both controlled trials and real‑world follow‑up in defined populations such as veterans
- Integration of pharmacologic innovation with care models, training, and safety monitoring that fit within systems like VA
- Willingness to operate inside formal data‑sharing and governance frameworks that connect to both regulators and payers
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