Trump signs executive order to speed psychedelic treatments for serious mental illness

President Donald Trump on Friday signed an executive order directing federal agencies to speed the development, regulatory review and potential patient access pathways for psychedelic treatments for serious mental illness.

The order, titled “Accelerating Medical Treatments for Serious Mental Illness,” was posted by the White House on April 18, 2026, and signed “DONALD J. TRUMP.” It states: “It is the policy of my Administration to accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness in America.” The text explicitly refers to “psychedelic drugs, including ibogaine compounds.”

The order lays out a series of concrete steps across the Food and Drug Administration, the Drug Enforcement Administration, the Department of Health and Human Services, the Department of Veterans Affairs and the Justice Department. It directs the FDA commissioner to provide Commissioner’s National Priority Vouchers to appropriate psychedelic drugs that already have Breakthrough Therapy designation, an FDA program designed to speed development and review for treatments for serious conditions when early evidence suggests they may substantially improve on existing options.

It also tells the FDA and DEA to “facilitate and establish a pathway” for eligible patients to access psychedelic drugs under the federal Right to Try Act, including any necessary Schedule I handling authorizations for doctors and researchers, consistent with federal law. HHS is directed to allocate at least $50 million from existing funds through the Advanced Research Projects Agency for Health, or ARPA-H, to support and partner with state governments developing psychedelic programs, including through funding, technical assistance and data sharing as permitted by law.

In addition, HHS and the FDA are told to work with the VA and, where appropriate, the private sector to increase clinical trial participation, data sharing and real-world evidence generation on psychedelic drugs, including data-sharing memoranda where appropriate. The attorney general, in consultation with HHS, is directed to begin and complete a review of any product containing a Schedule I substance that has successfully completed Phase 3 clinical trials for a serious mental health disorder so that rescheduling, if appropriate, can proceed “as quickly as practicable” once the FDA approves that product.

The administration frames the order as a response to mental illness, suicide and veteran suicide. The order says “over 14 million American adults have a serious mental illness,” and adds that “about 8 million are on prescription medication for these conditions.” It says suicide rates rose 37% from 2000 to 2018, fell 5% from 2018 to 2020, and then returned to a peak rate in 2022. On veterans, the order says there have been more than 6,000 veteran suicides per year for more than 20 years and that the veteran suicide rate is more than twice that of the non-veteran adult population.

Breakthrough Therapy designation, one of the tools cited in the order, is an existing FDA program intended to speed review of drugs for serious conditions. Psychedelic treatment programs have previously received that designation, including MDMA-assisted therapy for post-traumatic stress disorder and COMPASS Pathways’ psilocybin program for treatment-resistant depression.

Even so, the order relies on legal and regulatory mechanisms that have limits. The Right to Try Act applies to eligible patients with a life-threatening disease or condition, which could raise implementation questions for serious mental illnesses that do not clearly fit that definition. And while the order pushes agencies to move faster on products involving Schedule I substances, rescheduling under the Controlled Substances Act still requires the usual scientific evaluation by HHS and the formal DEA and Justice Department process.

The order also includes standard limitations on what it can do. It says the directives must be carried out consistent with applicable law and subject to the availability of appropriations. It further states that it does not create any enforceable legal right or benefit for any party against the United States, its agencies, officers or employees.