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

WASHINGTON—JULY 13, 2026—The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Veterans Affairs (VA) today entered into a Memorandum of Understanding (MOU) to strengthen collaboration on the research, clinical development, and responsible deployment to veterans suffering from serious mental health conditions of potential future rapid-acting psychedelic drug products if approved by the Food & Drug Administration.

“America owes every veteran the best care our nation can provide,” said HHS Secretary Robert F. Kennedy, Jr. “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.”

The agreement advances President Trump’s Executive Order 14401, Accelerating Medical Treatments for Serious Mental Illness, which specifically called on the VA to work with HHS to increase clinical trial participation and share data as appropriate and consistent with legal authority with the FDA to ensure that successful trials lead to the timely evaluation and approval of these drugs.

“President Trump opened up a world of possibility for treating Veterans and others with mental health conditions, and VA is proud to be part of this important work,” said VA Secretary Doug Collins. “Today’s MOU ensures effective cooperation with HHS as we try to turn research into life-changing treatment.”

Under the agreement, HHS and VA will coordinate workforce training, develop evidence-based clinical protocols, support research and real-world evidence generation, and prepare the VA healthcare system to responsibly implement future FDA-approved rapid-acting psychiatric drug products as they become available.

Together, the Departments will prepare for the deployment of future FDA-approved rapid-acting psychiatric drug products for serious behavioral health conditions by:

• Increasing participation in clinical research on promising rapid-acting mental health treatments for veterans
• Training therapists, nurses, physicians, and other clinicians to safely administer future FDA-approved rapid-acting psychiatric drug products
• Collecting and sharing real-world data on the safety, effectiveness, and costs of these treatments to improve patient care and inform future policy
• Coordinating research and sharing evidence as appropriate and consistent with legal authority that may help inform future FDA regulatory decisions and coverage policies
• Developing clinical guidance and educational resources to help providers — and ultimately patients — understand how approved treatments should be delivered safely and effectively

The agreement remains in force for five years, with the option to renew.

FDA and the VA are also entering into a separate, complementary MOU in which the agencies will expand information-sharing and scientific collaboration as appropriate and consistent with applicable law to help advance the development and evaluation of innovative therapies for serious mental illnesses. FDA is also announcing a series of actions to advance the development of psychedelic drug therapies for serious mental illnesses, including issuing a final guidance for industry, Psychedelic Drugs: Considerations for Clinical Investigations, and announcing a public hearing on the potential future therapeutic use of psychedelic drugs.

“Too many Americans and their families continue to be affected by substance use disorder and serious mental illness, and we have a responsibility to pursue every appropriate opportunity to advance new treatment options,” said FDA Acting Commissioner Kyle Diamantas, J.D. “This agreement strengthens collaboration between the FDA and the Department of Veterans Affairs, allowing us to better leverage clinical trial data, real-world evidence, and scientific expertise to help speed the development and review of promising therapies while maintaining our rigorous standards for safety and effectiveness. By working together, we can help deliver new hope to patients who urgently need better treatment options.”

The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), has studied ibogaine — a naturally occurring psychedelic being investigated as a potential treatment for opioid use disorder — for decades. As part of that work, NIDA recently revived and validated data from earlier ibogaine studies and shared those data with the FDA and researchers to help inform the drug’s ongoing scientific and regulatory evaluation.

In a complementary effort, NIDA has awarded funding for a multi-phase research project to support an Investigational New Drug (IND) application to the FDA, a required step before clinical trials can begin. Earlier studies suggest ibogaine may help treat opioid use disorder but have also identified an increased risk of serious heart rhythm problems. Contingent on the IND, the new research will include clinical trials to evaluate whether updated dosing and administration approaches can reduce those risks while preserving the drug’s potential benefits.

“There is preliminary evidence that psychedelic therapies can rewire the brain and produce rapid improvements for people with serious mental illness or substance use disorders,” said NIH Director Jay Bhattacharya, M.D., Ph.D. “However, we still have much to learn about long-term benefits and risks, including the potential for misuse. This collaboration helps strengthen the scientific foundation and clinical readiness needed to support safe, effective, real-world implementation.”

The HHS Advanced Research Projects Agency for Health (ARPA-H) is inviting researchers and companies to compete for funding to help advance research on ibogaine as a potential treatment for opioid use disorder. Funding will support early clinical development and preparation for FDA review, while also exploring ways to keep future treatments affordable and accessible.

“Treatment for opioid use disorder has been stuck in an innovation rut for decades, and Americans are paying a heartbreaking price,” said ARPA-H Director Dr. Alicia Jackson. “ARPA-H is poised to take bold action and knock down barriers to exploring the therapeutic potential of ibogaine for this devastating condition.”

Additionally, the HHS Health Resources and Services Administration (HRSA) is issuing a Request for Information (RFI) on July 14 to gather stakeholder input on how the healthcare workforce and care-delivery system should prepare for potential future FDA-approved psychedelic drug products. The RFI seeks recommendations on clinician education and training, evidence-based care delivery models, and approaches for safely delivering these therapies in community-based settings (including Federally Qualified Health Centers, Rural Health Clinics, and Certified Community Behavioral Health Clinics) to help inform future HRSA guidance and technical assistance.

“HRSA is committed to ensuring that health professionals and community-based healthcare providers are prepared to safely and effectively deliver innovative therapies as new options become available for people living with serious mental illness,” said HRSA Administrator Tom Engels. “By seeking input from clinicians, health centers, behavioral health providers, rural health experts, researchers, and other stakeholders, HRSA will be better positioned to understand the workforce training, care delivery models, and operational considerations needed to support the safe implementation of potential FDA-approved psychedelic drug products in the future.”

These coordinated actions reflect the Trump administration’s commitment to accelerate research, strengthen clinical readiness, and expand access to innovative treatments for veterans and other Americans living with serious mental illness.