Accelerating Medical Treatments for Serious Mental Illness

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. 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.

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.

    (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,

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.

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.

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.

    (d) The costs for publication of this order shall
be borne by the Department of Health and Human
Services.

    (Presidential Sig.)

THE WHITE HOUSE,

    April 18, 2026.