Accelerating Medical Treatments for Serious Mental Illness

[Federal Register Volume 91, Number 77 (Wednesday, April 22, 2026)]

[Presidential Documents]

[Pages 21709-21711]

From the Federal Register Online via the Government Publishing Office [www.gpo.gov]

[FR Doc No: 2026-07907]

[[Page 21707]]

Vol. 91

Wednesday,

No. 77

April 22, 2026

Part IV

The President

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Executive Order 14401--Accelerating Medical Treatments for Serious

Mental Illness

Presidential Documents

Federal Register / Vol. 91 , No. 77 / Wednesday, April 22, 2026 /

Presidential Documents

___________________________________________________________________

Title 3--

The President

[[Page 21709]]

Executive Order 14401 of April 18, 2026

Accelerating Medical Treatments for Serious

Mental Illness

By the authority vested in me as President by the

Constitution and the laws of the United States of

America, it is hereby ordered:

Section 1. Purpose and Policy. Policymakers and the

medical field have long struggled to address the burden

of suicide and serious mental illness rates in America.

Today, over 14 million American adults have a serious

mental illness, defined as having a diagnosable mental,

behavioral, or emotional disorder that substantially

interferes with a person's life and ability to

function, and about 8 million are on prescription

medication for these conditions. Suicide rates

tragically increased by 37 percent from 2000 to 2018.

During my first term, we made historic progress in

helping those struggling with some of the most

insidious mental illnesses, and suicide rates decreased

by 5 percent from 2018 to 2020

mental illness, defined as having a diagnosable mental,

behavioral, or emotional disorder that substantially

interferes with a person's life and ability to

function, and about 8 million are on prescription

medication for these conditions. Suicide rates

tragically increased by 37 percent from 2000 to 2018.

During my first term, we made historic progress in

helping those struggling with some of the most

insidious mental illnesses, and suicide rates decreased

by 5 percent from 2018 to 2020. 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. Critically,

veterans often suffer in greater measure from this

tragedy. For over 20 years, there have been more than

6,000 veteran suicides per year, and the current

veteran suicide rate is more than twice as much as the

non-veteran adult population.

Individuals suffering from major depressive disorder

and substance abuse disorder, among other serious

mental illnesses, can relapse or not fully respond to

standard medical and psychiatric therapies. Despite

massive Federal investment into researching potential

advancements in mental health care and treatment, our

medical research system has yet to produce approved

therapies that promote enduring improvements in the

mental health condition of these most complex patients.

Innovative methods are needed to find long-term

solutions for these Americans beyond existing

prescription medications.

and treatment, our

medical research system has yet to produce approved

therapies that promote enduring improvements in the

mental health condition of these most complex patients.

Innovative methods are needed to find long-term

solutions for these Americans beyond existing

prescription medications.

Psychedelic drugs, including ibogaine compounds, show

potential in clinical studies to address serious mental

illnesses for patients whose conditions persist after

completing standard therapy. Indeed, the Food and Drug

Administration (FDA) has granted Breakthrough Therapy

designation to specific psychedelic drugs, and there

are numerous products currently in the clinical trial

pipeline for review of safety and efficacy. 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.

Sec. 2. FDA Review Prioritization and Right to Try. (a)

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 are in accordance

with the criteria of the National Priority Voucher

Program.

w Prioritization and Right to Try. (a)

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 are in accordance

with the criteria of the National Priority Voucher

Program.

(b) The FDA and Drug Enforcement Administration

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), including 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.

Sec. 3. Department of Health and Human Services Funding

for Federal-State Collaboration. The Secretary of

Health and Human Services shall,

[[Page 21710]]

through the Advanced Research Projects Agency for

Health, allocate at least $50 million from existing

funds to support and partner with State governments

that have enacted or are developing programs to advance

psychedelic drugs for serious mental illnesses,

including through Federal funding, technical

assistance, and data sharing as appropriate and

consistent with applicable law.

ion from existing

funds to support and partner with State governments

that have enacted or are developing programs to advance

psychedelic drugs for serious mental illnesses,

including through Federal funding, technical

assistance, and data sharing as appropriate and

consistent with applicable law.

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 shall collaborate with the

Department of Veterans Affairs (VA) and, as appropriate

and consistent with applicable law, including any

privacy restrictions from the Privacy Act of 1974 and

the Health Insurance Portability and Accountability Act

of 1996, with the private sector, to increase clinical

trial participation, data sharing, and real-world

evidence generation regarding psychedelic drugs, and

shall prioritize drugs that have received a

Breakthrough Therapy designation. The HHS, FDA, and VA

are directed to sign data-sharing memoranda as

appropriate to ensure that data from relevant clinical

studies conducted by other executive departments and

agencies is made available to FDA to facilitate the

timely evaluation and approval of drugs that meet

standards for approval under section 505 of the Federal

Food, Drug, and Cosmetic Act.

as

appropriate to ensure that data from relevant clinical

studies conducted by other executive departments and

agencies is made available to FDA to facilitate the

timely evaluation and approval of drugs that meet

standards for approval under section 505 of the Federal

Food, Drug, and Cosmetic Act.

Sec. 5. Timely Rescheduling. 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, so 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.

Sec. 6. General Provisions. (a) Nothing in this order

shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or

the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget

relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with

applicable law and subject to the availability of

appropriations.

(c) This order is not intended to, and does not,

create any right or benefit, substantive or procedural,

enforceable at law or in equity by any party against

the United States, its departments, agencies, or

entities, its officers, employees, or agents, or any

other person.

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ions.

(c) This order is not intended to, and does not,

create any right or benefit, substantive or procedural,

enforceable at law or in equity by any party against

the United States, its departments, agencies, or

entities, its officers, employees, or agents, or any

other person.

[[Page 21711]]

(d) The costs for publication of this order shall

be borne by the Department of Health and Human

Services.

<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>

(Presidential Sig.)

THE WHITE HOUSE,

April 18, 2026.

[FR Doc. 2026-07907

Filed 4-21-26; 11:15 am]

Billing code 4150-28-P

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