WASHINGTON\u2014JULY 13, 2026\u2014The 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.<\/p>\n
\u201cAmerica owes every veteran the best care our nation can provide,\u201d said HHS Secretary Robert F. Kennedy, Jr. \u201cWe\u2019re not going to wait while promising treatments sit on the sidelines. Thanks to President Trump\u2019s 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.\u201d<\/p>\n
The agreement advances President Trump\u2019s Executive Order 14401, Accelerating Medical Treatments for Serious Mental Illness<\/a>, 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.<\/p>\n \u201cPresident 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,\u201d said VA Secretary Doug Collins. \u201cToday\u2019s MOU ensures effective cooperation with HHS as we try to turn research into life-changing treatment.\u201d<\/p>\n 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.<\/p>\n Together, the Departments will prepare for the deployment of future FDA-approved rapid-acting psychiatric drug products for serious behavioral health conditions by:<\/p>\n Increasing participation in clinical research on promising rapid-acting mental health treatments for veteransTraining therapists, nurses, physicians, and other clinicians to safely administer future FDA-approved rapid-acting psychiatric drug productsCollecting and sharing real-world data on the safety, effectiveness, and costs of these treatments to improve patient care and inform future policyCoordinating research and sharing evidence as appropriate and consistent with legal authority that may help inform future FDA regulatory decisions and coverage policiesDeveloping clinical guidance and educational resources to help providers \u2014 and ultimately patients \u2014 understand how approved treatments should be delivered safely and effectively<\/p>\n The agreement remains in force for five years, with the option to renew.<\/p>\n FDA and the VA are also entering into a separate, complementary MOU<\/a> 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<\/a> 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<\/a>, and announcing a public hearing<\/a> on the potential future therapeutic use of psychedelic drugs.<\/p>\n \u201cToo 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,\u201d said FDA Acting Commissioner Kyle Diamantas, J.D. \u201cThis 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.\u201d<\/p>\n The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), has studied ibogaine \u2014 a naturally occurring psychedelic being investigated as a potential treatment for opioid use disorder \u2014 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\u2019s ongoing scientific and regulatory evaluation.<\/p>\n