WASHINGTON, D.C. — President Donald J. Trump has signed an executive order directing federal agencies to accelerate research, regulatory review, and potential patient access for experimental psychedelic drugs aimed at treating serious mental illnesses, with a particular focus on veterans and patients who do not respond to standard therapies.
What This Means for You
- Federal agencies are being directed to speed research and review of certain psychedelic therapies
- Veterans and other patients with treatment-resistant mental illness are a primary focus
- The order does not approve any new drug, but it expands pathways for trials, data sharing, and potential access
The order, signed April 18, calls on the U.S. Department of Health and Human Services, the Food and Drug Administration, the Department of Veterans Affairs, the Drug Enforcement Administration, and the Justice Department to take a series of steps intended to move experimental psychedelic treatments more quickly through research and regulatory channels.
The White House said the action is aimed at addressing high suicide rates, serious mental illness, and limited treatment options for patients with complex conditions such as post-traumatic stress disorder, major depressive disorder, anxiety, addiction, and substance use disorders.
What the Order Requires
Under the executive order, the FDA is directed to provide Commissioner’s National Priority Vouchers to qualifying psychedelic drugs that have already received Breakthrough Therapy designation and meet the standards of the voucher program.
The order also directs the FDA and DEA to establish a pathway under the federal Right to Try Act for eligible patients to access investigational psychedelic drugs, including ibogaine compounds, while those products remain under review. That process would also include any necessary handling authorizations for physicians and researchers working with Schedule I substances.
In addition, HHS is directed to allocate at least $50 million in existing funds through the Advanced Research Projects Agency for Health to support and partner with states that are advancing psychedelic drug programs for serious mental illnesses.
The order further instructs HHS and the FDA to collaborate with the VA and, where permitted by law, the private sector to expand clinical trial participation, data sharing, and real-world evidence generation. The agencies are also directed to sign data-sharing agreements, as appropriate, so information from relevant federal studies can be made available to the FDA.
If a product containing a Schedule I substance successfully completes Phase 3 clinical trials for a serious mental health disorder, the attorney general is directed to begin and complete a review so rescheduling can move forward as quickly as possible if the product is ultimately approved by the FDA.
Why Veterans Are a Focus
The order places particular attention on veterans, citing longstanding concerns about suicide and treatment-resistant mental illness among former service members.
According to the order, more than 14 million American adults have a serious mental illness, about 8 million are taking prescription medication for such conditions, and veteran suicide has exceeded 6,000 deaths per year for more than two decades. The order also states that the current veteran suicide rate is more than twice that of the non-veteran adult population.
Sen. Dave McCormick, R-PA, praised the action, saying, “The Trump EO clears federal roadblocks by directing HHS and the FDA to work with [the Department of Veterans Affairs] and the private sector on clinical trials for experimental psychedelic therapies… Veterans deserve safe, legitimate access to promising treatments for PTSD, depression, anxiety, and addiction.”
What Psychedelic Therapies Mean Here
Psychedelic drugs are a class of substances that can alter perception, mood, and cognition. In this context, federal officials are referring to experimental therapeutic uses of compounds such as ibogaine and other drugs now being studied in controlled clinical settings.
The White House said some psychedelic products have already received Breakthrough Therapy designation from the FDA, a status meant to speed development and review when preliminary evidence suggests a substantial improvement over existing therapies.
The administration also pointed to ongoing research at institutions including Stanford University, Harvard University, and Johns Hopkins University, as well as a 2025 Texas research consortium focused on ibogaine clinical trials and drug development.
What the Order Does Not Do
The executive order does not itself approve psychedelic drugs for medical use. Any therapy would still need to meet federal standards for safety and effectiveness through the FDA approval process.
The order also states that it must be implemented consistent with existing law and available appropriations, and that it does not create any enforceable legal right or benefit for private parties.
Next Steps
Federal agencies are now expected to begin implementing the order’s directives, including expanded coordination on trials, possible Right to Try access pathways, new research funding partnerships with states, and regulatory review of qualifying products.
Any broader availability of psychedelic therapies will depend on future clinical trial results, FDA approval decisions, and, where necessary, rescheduling actions by federal authorities.
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