Under the authority granted to me as President by the Constitution and the laws of the United States, the following order is issued:
Section 1. Purpose and Policy. Policymakers and medical professionals have long faced challenges in addressing the high rates of suicide and serious mental illness in America. Currently, over 14 million American adults are affected by serious mental illness, characterized by diagnosable mental, behavioral, or emotional disorders that significantly disrupt daily life and functionality. Approximately 8 million of these individuals are on prescription medication for these issues. Suicide rates increased by 37 percent from 2000 to 2018. During my first term, significant progress was made, leading to a 5 percent decrease in suicide rates from 2018 to 2020. However, the COVID-19 pandemic and the extended shutdown under the Biden Administration hindered this progress, causing suicide rates to rise again to their peak in 2022. Veterans are particularly affected, with over 6,000 veteran suicides each year for the past two decades, and the current veteran suicide rate is more than double that of the non-veteran adult population.
People suffering from major depressive disorder and substance abuse disorder, among other serious mental illnesses, may relapse or not fully benefit from standard medical and psychiatric treatments. Despite significant federal investment in mental health care and treatment research, the medical research system has not yet produced approved therapies that offer lasting improvements for these complex patients. Innovative approaches are necessary to find long-term solutions beyond current prescription medications.
Psychedelic drugs, such as ibogaine compounds, have shown promise in clinical studies for treating serious mental illnesses in patients who do not respond to standard therapy. The Food and Drug Administration (FDA) has recognized certain psychedelic drugs with Breakthrough Therapy designation, and many products are in the clinical trial pipeline for safety and efficacy review. My Administration’s policy is to accelerate innovative research models and facilitate drug approvals to expand access to potentially life-saving psychedelic drugs and address the mental health crisis in America.
Sec. 2. FDA Review Prioritization and Right to Try. (a) The Commissioner of Food and Drugs is directed to issue Commissioner’s National Priority Vouchers for psychedelic drugs that have received a Breakthrough Therapy designation, in line with the National Priority Voucher Program criteria.
(b) The FDA and Drug Enforcement Administration shall create a pathway for eligible patients to access psychedelic drugs, including ibogaine compounds, under the Right to Try Act (21 U.S.C. 360bbb-0a). This includes necessary Schedule I handling authorizations for physicians and researchers, consistent with 21 U.S.C. 823, and applicable waiver authority under the Controlled Substances Act.
Sec. 3. Department of Health and Human Services Funding for Federal-State Collaboration. The Secretary of Health and Human Services shall allocate at least $50 million from existing funds through the Advanced Research Projects Agency for Health to support state government programs advancing psychedelic drugs for serious mental illnesses. This includes federal funding, technical assistance, and data sharing, as appropriate and lawful.
Sec. 4. Department of Health and Human Services and FDA Collaboration with the Department of Veterans Affairs and the Private Sector. The Department of Health and Human Services (HHS) and FDA will collaborate with the Department of Veterans Affairs (VA) and, as appropriate and consistent with applicable laws, with the private sector. The goal is to increase clinical trial participation, data sharing, and real-world evidence generation regarding psychedelic drugs, prioritizing those with Breakthrough Therapy designation. The HHS, FDA, and VA are instructed to sign data-sharing agreements to ensure relevant clinical study data from other government departments and agencies is available to the FDA for timely drug evaluation and approval under section 505 of the Federal Food, Drug, and Cosmetic Act.
Sec. 5. Timely Rescheduling. The Attorney General, in consultation with HHS, shall promptly review any product containing a Schedule I substance that has completed Phase 3 clinical trials for a serious mental health disorder. If appropriate under 21 U.S.C. 811, rescheduling should proceed swiftly for products approved under section 505 of the Federal Food, Drug, and Cosmetic Act.
Sec. 6. General Provisions. (a) This order shall not be interpreted to affect:
(i) the legal authority of an executive department or agency, or its head; or
(ii) the functions of the Director of the Office of Management and Budget related to budgetary, administrative, or legislative proposals.
(b) This order will be implemented in accordance with applicable law and subject to available funding.
(c) This order does not create any enforceable right or benefit for any party against the United States, its departments, agencies, or individuals.
(d) The Department of Health and Human Services will bear the costs for publishing this order.
DONALD J. TRUMP
THE WHITE HOUSE,
April 18, 2026.
