VA, HHS sign MOU to improve cooperation on psychedelic drug trials

WASHINGTON - The Department of Veterans Affairs and Department of Health and Human Services signed a memorandum of understanding today to ensure the effective implementation of President Trump's Executive Order on Accelerating Medical Treatments for Serious Mental Illness.

Through that order, President Trump instructed his administration to explore whether psychedelic drugs might play a role in saving the lives of Veterans and others with serious mental illness. It specifically called on VA to work with HHS to increase clinical trial participation and share data with the Food & Drug Administration to ensure that successful trials lead to the timely evaluation and approval of these drugs.

The MOU signed today lays the groundwork for VA-HHS cooperation on psychedelic trials, which includes efforts to:

• Increase clinical trial participation
• Provide training for therapists, nurses and doctors involved in these trials
• Collect and share data on the effectiveness, safety and costs of these potential therapies
• Share data with the FDA so it can quickly approve tested treatments
• Develop educational materials so patients know what to expect when a successful trial leads to a new, approved treatment

A suite of accompanying actions being taken today by HHS in conjunction with the MOU to advance the partnership.

"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."

"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."

VA is involved in 20 active clinical trials focused on psychedelic therapies for mental health conditions that are supported by the VA Office of Research and Development and more than $23 million in external funding. All VA research, including research into psychedelics, is conducted under strict safety protocols and in full compliance with federal guidelines.

Psychedelic drugs are a class of substances that alter consciousness or awareness and can be organically or synthetically produced. VA trials are and will be conducted in accordance with FDA research guidelines, and clinical use of these therapies outside of research will only be considered by VA once FDA approval is granted.

VA strongly discourages self-medicating or attempting to replace other mental health treatment options with psychedelics or any other unprescribed substances. Proven, evidence-based treatments, are currently available at VA facilities to treat Veterans with mental health conditions. Veterans should always consult their health care providers before making any treatment decisions.