Executive Order 14401: Accelerating Medical Treatments for Serious Mental Illness
President: Donald J. Trump
Directed agencies to accelerate lawful research, review and future deployment of rapid-acting and psychedelic-derived treatments for serious mental illness.
Status: In effect. Is Executive Order 14401 still in effect? Yes. Executive Order 14401 remains in effect. See Federal Register record.
What does Executive Order 14401 do?
The text directs HHS and VA to coordinate research, trials, data and training, and FDA to issue scientific guidance and evaluate applications.
Reading the operative provisions of Executive Order 14401
EO 14401 directs HHS, the Department of Veterans Affairs and FDA to accelerate lawful research and review of treatments for serious mental illness, including rapid-acting and psychedelic-derived therapies. It calls for coordination on clinical trials, data and scientific guidance. The Federal Register text sets agency assignments; it does not approve a drug or make an investigational treatment available for general use.
Potential treatments must pass through clinical research and FDA review. Trials require informed consent, safety monitoring and ethical review, and an application must provide evidence of safety and effectiveness for the proposed use. Some compounds also remain controlled under federal drug law, so DEA registration and scheduling rules can affect research and distribution.
The order encourages agencies to support research, but it does not guarantee a positive FDA decision or replace a clinician’s judgment. VA research and care involve additional responsibilities to veterans and must follow privacy and safety rules. Patients should not stop an established treatment based on an executive order or preliminary study. Progress should be measured through registered trials, published evidence, agency decisions and access to approved care.
Rapid-acting therapies can have substantial psychological or physiological effects, making careful screening, monitoring and follow-up essential. Research protocols should define adverse-event reporting and protect participants who may be especially vulnerable. FDA can use existing expedited pathways when their criteria are met, but expedited review is not automatic approval. The order’s research agenda must preserve those safeguards while helping agencies coordinate trials and evidence.
Before and after
Before the order
Investigational psychiatric treatments required clinical evidence, FDA authorization and controlled-substance compliance before routine use or coverage.
After the order
HHS and VA signed a five-year MOU in July 2026 covering trials, data, workforce training and readiness for future FDA-approved products; no unapproved therapy became generally authorized.
Who had to do what
| Agency / office | Action | Timing / position |
|---|---|---|
| HHS and VA | Coordinate research, trials, data and training | Implemented in stages |
| FDA | Issue scientific guidance and evaluate applications | Ongoing |
| NIH and ARPA-H | Support evidence development | Ongoing |
What happened next
EO 14401 signed.
HHS and VA signed a five-year implementation MOU.
Legal and source detail
How it works legally
The FDCA, Controlled Substances Act, informed-consent and research rules, veterans law and coverage statutes remain. FDA safety and effectiveness standards are not waived.
Sources by type
If a source is unavailable, first check the cited publisher or another official repository. The cited publisher remains the authority.
Primary and official sources
Orders, laws, court records and official implementation material.
- HHS–VA partnership announcement (opens in a new tab) Official record
How we checked this
Last checked against the sources above on September 9, 2026. How we research →