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Executive Order on Accelerating Psychedelic Drug Access for Serious Mental Illness

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Summary

President Trump signed an Executive Order on April 18, 2026, directing FDA and DEA to accelerate psychedelic drug research and patient access for serious mental illness. The Order directs FDA to provide Commissioner National Priority Vouchers to qualifying psychedelic drugs with Breakthrough Therapy designation, requires HHS to allocate $50 million through ARPA-H to match state investments in psychedelic research, and directs the Attorney General to initiate rescheduling reviews upon successful Phase 3 clinical trials.

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What changed

The Executive Order establishes a multi-agency framework to accelerate psychedelic drug development and access for patients with serious mental illness. Key directives include: FDA providing priority review vouchers to psychedelic drugs meeting Breakthrough Therapy criteria; FDA and DEA creating patient access pathways under the Right to Try Act; HHS allocating $50 million in ARPA-H funding for state-matching research grants; and HHS/FDA collaborating with VA and private sector to increase clinical trial participation. The Order also directs the Attorney General to initiate rescheduling reviews upon Phase 3 completion.

For pharmaceutical companies developing psychedelic-based therapies, the Order creates a faster regulatory pathway through priority review vouchers and explicit coordination between FDA and DEA on access programs. Healthcare providers treating serious mental illness patients may see new treatment options emerge more quickly. Mental health advocates and veterans' organizations may benefit from increased research funding and expanded access programs. Federal agencies must coordinate implementation across FDA, DEA, HHS, VA, and DOJ.

What to do next

  1. FDA Commissioner must provide National Priority Vouchers to qualifying psychedelic drugs with Breakthrough Therapy designation
  2. FDA and DEA must establish pathway for eligible patients to access investigational psychedelic drugs under Right to Try Act
  3. HHS Secretary must allocate $50 million through ARPA-H to match state investments in psychedelic research
  4. Attorney General must initiate reviews for rescheduling upon successful Phase 3 trial completion

Archived snapshot

Apr 18, 2026

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Fact Sheets

Fact Sheet: President Donald J. Trump is Accelerating Medical Treatments for Serious Mental Illness

The White House

April 18, 2026

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.

Named provisions

National Priority Voucher Program Right to Try Act Pathway ARPA-H Funding Allocation Clinical Trial Collaboration Rescheduling Reviews

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Last updated

Classification

Agency
WH
Published
April 18th, 2026
Instrument
Rule
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Executive Order (April 18, 2026)

Who this affects

Applies to
Government agencies Healthcare providers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug development incentives Clinical trial expansion Controlled substance scheduling
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Healthcare
Compliance frameworks
Right to Try Act
Topics
Pharmaceuticals Public Health

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