REMOVING BARRIERS TO PSYCHEDELIC DRUGS AS POTENTIAL TREATMENT FOR SERIOUS MENTAL ILLNESS: Today, President Donald J. Trump signed an Executive Order that will accelerate access to treatments for patients with serious mental illness, reaffirming his commitment to advancing solutions that provide hope to Americans with devastating, complex, and treatment-resistant conditions.
- The Order directs the Food and Drug Administration (FDA) Commissioner to provide Commissioner’s National Priority Vouchers to appropriate psychedelic drugs that have received Breakthrough Therapy designations for treating serious mental illnesses, and that meet the criteria of the National Priority Voucher Program. This will ensure that red tape does not delay the FDA’s gold standard review of any potential therapy.
- The Order further directs the FDA and the Drug Enforcement Agency to establish a pathway for eligible patients to access investigational psychedelic drugs, including ibogaine compounds, that are under FDA review and that have met basic safety requirements under President Trump’s landmark Right to Try Act.
- The Order requires the Secretary of Health and Human Services (HHS) to allocate $50 million through the Advanced Research Projects for Health (ARPA-H) program to match investments made by state governments to advance research into psychedelic programs for populations with serious mental illness.
- The Order requires HHS and the FDA to collaborate with the Department of Veterans Affairs and the private sector to increase clinical trial participation and evidence generation surrounding experimental psychedelic therapies.
- The Order directs the Attorney General to initiate reviews of relevant products upon successful completion of their Phase 3 clinical trials so that they can be rescheduled as soon as possible upon FDA approval, where appropriate.
ACCELERATING TREATMENTS TO BENEFIT ALL AMERICANS, ESPECIALLY OUR BRAVE MILITARY VETERANS: America has long struggled to address the burden of suicide and serious mental illness rates in America, with our veterans often suffering in greater measure. President Trump is working to bring about new options for patients whose conditions have not responded to existing treatments.
- Today, over 14 million American adults have a serious mental illness— a diagnosable mental, behavioral, or emotional disorder that substantially interferes with a person’s life and ability to function.
- 8 million of these are on prescription medication for their conditions.
- Suicide rates during the first Trump Administration decreased for the first time since 2000. The COVID-19 pandemic and the Biden Administration’s prolonged shutdown stunted this progress, and suicide rates rebounded upwards again to their peak rate in 2022.
- America’s brave veterans often suffer in greater measure from the tragedy of suicide.
- For over 20 years, there have been more than 6,000 veteran suicides per year.
- The suicide rate among veterans is more than twice as high as that of the non-veteran adult population.
- World-leading medical research institutions, including Stanford University, Harvard University, and Johns Hopkins University, are studying therapies involving psychedelics, and experts believe the results could be promising.
- The FDA has granted Breakthrough Therapy designation to some psychedelic drugs that have shown preliminary clinical evidence of substantial improvement over other current therapies.
- In 2025, the state of Texas recognized this potential and launched a research consortium to accelerate ibogaine clinical trials and drug development.
DELIVERING RESULTS FOR PATIENTS: President Trump has long been committed to accelerating medical treatment development and to ensure Americans and our veterans struggling with complex, hard to treat, and even incurable diseases and mental illnesses are able to access the care they need.
- In President Trump’s first term, he worked to pass and sign into law the landmark Right to Try Act, giving terminally ill patients a pathway to access potentially lifesaving treatments under FDA review.
- Also during his first term, President Trump signed an Executive Order to ensure all veterans have seamless access to high-quality mental healthcare and suicide prevention resources as they transition from uniformed service to civilian life, especially during the critical first year in which the suicide rates are known to be higher.
- In 2025, President Trump signed into law the HALT Fentanyl Act, which significantly reformed research activities on controlled substances, including the process for conducting medical research on Schedule I substances, which will accelerate the important research on psychedelic drugs.