Executive Order

Executive Order 14401 of April 18, 2026 Accelerating Medical Treatments for Serious Mental Illness

ActiveExecutive Orders

Published

April 18, 2026

Lineage

—

Ingested

June 29, 2026

Summary

Executive Order 14401, issued by the President on April 18, 2026, aims to accelerate the development and patient access to innovative medical treatments, particularly psychedelic drugs, for serious mental illnesses. It directs the FDA to prioritize review and facilitate patient access to breakthrough psychedelic therapies under the Right to Try Act, while allocating $50 million in HHS funding for state programs advancing these treatments. The order also mandates inter-agency collaboration for clinical research and data sharing, and requires the Attorney General to expedite rescheduling reviews for relevant Schedule I substances.

Key provisions

Executive Order 14401 of April 18, 2026: Accelerating Medical Treatments for Serious Mental Illness

This Executive Order, signed on April 18, 2026, addresses the national crisis of serious mental illness (SMI) and suicide, particularly among veterans, and outlines the Administration's policy to accelerate the development and approval of innovative medical treatments, specifically focusing on psychedelic drugs.

Section 1. Purpose and Policy

The Executive Order acknowledges the significant burden of suicide and serious mental illness in the United States, noting that over 14 million American adults have SMI and 8 million are on prescription medication. Suicide rates tragically increased by 37% from 2000-2018, rebounded to peak in 2022 after a brief decrease, and disproportionately affect veterans, with over 6,000 veteran suicides annually for over 20 years.
It highlights that existing standard medical and psychiatric therapies are often insufficient for patients with major depressive disorder and substance abuse disorder, who may relapse or not fully respond.
The Administration's policy is to accelerate innovative research models and appropriate drug approvals for psychedelic drugs, such as ibogaine compounds, which show potential in clinical studies for patients whose conditions persist after standard therapy, especially those granted Breakthrough Therapy designation by the FDA.

Section 2. FDA Review Prioritization and Right to Try

Directive: The Commissioner of Food and Drugs shall provide Commissioner’s National Priority Vouchers to appropriate psychedelic drugs that have received a Breakthrough Therapy designation and meet the criteria of the National Priority Voucher Program.
Compliance Requirement: The FDA and Drug Enforcement Administration (DEA) shall facilitate and establish a pathway for eligible patients to access psychedelic drugs, including ibogaine compounds, under the Right to Try Act (21 U.S.C. 360bbb–0a).
Compliance Requirement: This pathway must include any necessary Schedule I handling authorizations for treating physicians and researchers, consistent with 21 U.S.C. 823, and any applicable waiver authority under the Controlled Substances Act.

Section 3. Department of Health and Human Services Funding for Federal-State Collaboration

Directive: The Secretary of Health and Human Services (HHS), through the Advanced Research Projects Agency for Health (ARPA-H), shall allocate at least $50 million from existing funds.
Purpose: These funds are to support and partner with State governments that have enacted or are developing programs to advance psychedelic drugs for serious mental illnesses.
Support may include Federal funding, technical assistance, and data sharing, consistent with applicable law.

Section 4. Department of Health and Human Services and FDA Collaboration with the Department of Veterans Affairs and the Private Sector

Directive: HHS and FDA shall collaborate with the Department of Veterans Affairs (VA) and, as appropriate and consistent with applicable law (including privacy restrictions from the Privacy Act of 1974 and HIPAA), with the private sector.
Purpose: The collaboration aims to increase clinical trial participation, data sharing, and real-world evidence generation regarding psychedelic drugs, prioritizing those with Breakthrough Therapy designation.
Compliance Requirement: HHS, FDA, and VA are directed to sign data-sharing memoranda as appropriate to ensure data from relevant clinical studies conducted by other executive departments and agencies is made available to FDA to facilitate timely evaluation and approval of drugs.

Section 5. Timely Rescheduling

Compliance Requirement: The Attorney General shall, in consultation with HHS, initiate and complete review of any product containing a Schedule I substance that has successfully completed Phase 3 clinical trials for a serious mental health disorder.
Purpose: This review is to ensure that rescheduling, if appropriate under 21 U.S.C. 811, may proceed as quickly as practicable for such specific products that are ultimately approved under section 505 of the Federal Food, Drug, and Cosmetic Act.

Section 6. General Provisions

The order clarifies that it does not impair the statutory authority of any executive department or agency, or the functions of the Office of Management and Budget related to budgetary, administrative, or legislative proposals.
Implementation is subject to applicable law and the availability of appropriations.
The order does not create any enforceable rights or benefits against the United States.
Directive: The Department of Health and Human Services shall bear the costs for the publication of this order.

Ask this document

Enter

Knowledge graph

This document

Executive Orders

Belongs to

Executive Orders

View original PDF →

Full document

Executive Order 14401 of April 18, 2026: Accelerating Medical Treatments for Serious Mental Illness

Section 1. Purpose and Policy

The Executive Order acknowledges the significant burden of suicide and serious mental illness in the United States, noting that over 14 million American adults have SMI and 8 million are on prescription medication. Suicide rates tragically increased by 37% from 2000-2018, rebounded to peak in 2022 after a brief decrease, and disproportionately affect veterans, with over 6,000 veteran suicides annually for over 20 years.

It highlights that existing standard medical and psychiatric therapies are often insufficient for patients with major depressive disorder and substance abuse disorder, who may relapse or not fully respond.

The Administration's policy is to accelerate innovative research models and appropriate drug approvals for psychedelic drugs, such as ibogaine compounds, which show potential in clinical studies for patients whose conditions persist after standard therapy, especially those granted Breakthrough Therapy designation by the FDA.

Section 2. FDA Review Prioritization and Right to Try

Directive: The Commissioner of Food and Drugs shall provide Commissioner’s National Priority Vouchers to appropriate psychedelic drugs that have received a Breakthrough Therapy designation and meet the criteria of the National Priority Voucher Program.

Compliance Requirement: The FDA and Drug Enforcement Administration (DEA) shall facilitate and establish a pathway for eligible patients to access psychedelic drugs, including ibogaine compounds, under the Right to Try Act (21 U.S.C. 360bbb–0a).

Compliance Requirement: This pathway must include any necessary Schedule I handling authorizations for treating physicians and researchers, consistent with 21 U.S.C. 823, and any applicable waiver authority under the Controlled Substances Act.

Section 3. Department of Health and Human Services Funding for Federal-State Collaboration

Directive: The Secretary of Health and Human Services (HHS), through the Advanced Research Projects Agency for Health (ARPA-H), shall allocate at least $50 million from existing funds.

Purpose: These funds are to support and partner with State governments that have enacted or are developing programs to advance psychedelic drugs for serious mental illnesses.

Support may include Federal funding, technical assistance, and data sharing, consistent with applicable law.

Section 4. Department of Health and Human Services and FDA Collaboration with the Department of Veterans Affairs and the Private Sector

Directive: HHS and FDA shall collaborate with the Department of Veterans Affairs (VA) and, as appropriate and consistent with applicable law (including privacy restrictions from the Privacy Act of 1974 and HIPAA), with the private sector.

Purpose: The collaboration aims to increase clinical trial participation, data sharing, and real-world evidence generation regarding psychedelic drugs, prioritizing those with Breakthrough Therapy designation.

Compliance Requirement: HHS, FDA, and VA are directed to sign data-sharing memoranda as appropriate to ensure data from relevant clinical studies conducted by other executive departments and agencies is made available to FDA to facilitate timely evaluation and approval of drugs.

Section 5. Timely Rescheduling

Compliance Requirement: The Attorney General shall, in consultation with HHS, initiate and complete review of any product containing a Schedule I substance that has successfully completed Phase 3 clinical trials for a serious mental health disorder.

Purpose: This review is to ensure that rescheduling, if appropriate under 21 U.S.C. 811, may proceed as quickly as practicable for such specific products that are ultimately approved under section 505 of the Federal Food, Drug, and Cosmetic Act.

Section 6. General Provisions

The order clarifies that it does not impair the statutory authority of any executive department or agency, or the functions of the Office of Management and Budget related to budgetary, administrative, or legislative proposals.

Implementation is subject to applicable law and the availability of appropriations.

The order does not create any enforceable rights or benefits against the United States.

Directive: The Department of Health and Human Services shall bear the costs for the publication of this order.