Two Trump administration cabinet members have announced that their departments are launching a new partnership to collaborate on research and development of psychedelic medicines to treat people struggling with serious mental health conditions.
The Department of Health and Human Services (HHS) and Department of Veterans Affairs (VA) signed a memorandum of understanding, unveiled on Monday, that comes months after President Donald Trump issued an executive order aimed at expanding and expediting research on the potential therapeutic benefits of psychedelics.
“America owes every veteran the best care our nation can provide,” HHS Secretary Robert F. Kennedy, Jr. said in a press release. “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.”
VA Secretary Doug Collins said that “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.”
“Today’s MOU ensures effective cooperation with HHS as we try to turn research into life-changing treatment,” he said.
Under the MOU, the two departments will coordinate workforce training, develop clinical protocols and support research and real-world evidence generation. The goal is to prepare VA’s healthcare system to be able to implement any psychedelic medicines that receive Food and Drug Administration (FDA) approval.
The press release says HHS and VA will specifically collaborate under the five-year agreement 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
A second MOU announced on Monday between VA and FDA is aimed at bolstering information-sharing and scientific collaboration to advance psychedelic medicine development.
“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,” FDA Acting Commissioner Kyle Diamantas said. “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.”
Meanwhile, the National Institute on Drug Abuse (NIDA) also announced that it is awarding $2.3 million to support an investigational new drug application for ibogaine.
“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,” National Institutes of Health Director Jay Bhattacharya said. “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.”
Additionally, the HHS Advanced Research Projects Agency for Health (ARPA-H) is making available separate funds to support research on ibogaine’s role in treating opioid use disorder.
“Treatment for opioid use disorder has been stuck in an innovation rut for decades, and Americans are paying a heartbreaking price,” ARPA-H Director Alicia Jackson said. “ARPA-H is poised to take bold action and knock down barriers to exploring the therapeutic potential of ibogaine for this devastating condition.”
Finally, the HHS Health Resources and Services Administration (HRSA) issued a request for information on how the healthcare system should prepare to implement psychedelic medicines.
“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,” HRSA Administrator Tom Engels said. “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.”
Separately on Monday, FDA issued finalized guidance to help researchers studying the therapeutic benefits of psychedelics navigate the “unique challenges” of such investigations. The agency also announced it will be holding a public hearing on psychedelic therapy issues in September.
Previously, FDA and HHS in April announced steps that they say will help with “accelerating” therapeutic access to psychedelics for patients dealing with serious mental health conditions.
In May, a bipartisan coalition of 32 members of Congress sent a letter urging FDA to expedite ongoing reviews of psychedelic therapies.
This month, lawmakers filed a new bill that would require the Department of Defense (DOD) to evaluate how ongoing research on the therapeutic benefits of psilocybin could help members of the military.
A separate recently introduced bipartisan measure is intended to codify Trump’s psychedelics executive order into law.
A pending proposed amendment to the National Defense Authorization Act would extend a psychedelics research effort at DOD for an additional six years.
Image courtesy of CostaPPR.
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