Norshroom

What Executive Order 14401 does, and doesn't do, for psilocybin

The April 2026 order put the White House behind faster review of psychedelic drugs. Six months on, here's what it has changed and what it leaves alone.

By Norshroom EditorsPublished

On April 18, 2026, President Trump signed Executive Order 14401, "Accelerating Medical Treatments for Serious Mental Illness." It directs federal agencies to move promising psychedelic drugs through review faster and to help states that run their own programs.1 It doesn't legalize psilocybin or any other psychedelic.

What the order directs

  • Priority review. The FDA is to award Commissioner's National Priority Vouchers to suitable psychedelic drugs that already have Breakthrough Therapy designation.1 Six days later, it gave vouchers to Compass Pathways' COMP360, Usona Institute's psilocybin and a methylone drug for PTSD.4
  • Right to Try. The FDA and DEA are to create a path for seriously ill patients to try investigational psychedelics, including ibogaine compounds, before approval.1
  • Money for states. HHS is to direct at least $50 million from existing funds, through ARPA-H, to support state psychedelic programs.1
  • Data sharing. HHS, FDA and the Department of Veterans Affairs are to share research data more widely.1 HHS and the VA signed a five-year agreement in July 2026 covering veteran trial enrollment and clinician training.5
  • Rescheduling. The Attorney General is to review rescheduling for drugs that finish Phase 3 trials and win FDA approval.1

The order sets no specific deadlines.1 Coverage of the signing noted safety concerns about ibogaine, which has been linked to more than 30 deaths in the medical literature and can cause dangerous heart rhythms.2

What it doesn't do

The order doesn't change the Controlled Substances Act. Psilocybin and psilocybin mushrooms stay in Schedule I, and possessing, growing or selling them remains a federal crime. In a Q&A from Harvard Law School's Petrie-Flom Center, law professor Mason Marks pointed to scholarship arguing that a president can't compel the rescheduling of a controlled substance.3 State laws are unaffected; see our legal status map for those.

What's happened since

The FDA held a public hearing on September 14, 2026 on how approved psychedelic treatments might be delivered. More than 18,000 people registered, and testimony covered provider training, patient safety, insurance coverage and data standards. Legalization and individual drug applications were outside its scope.6,7 The first application to benefit from the faster review, COMP360, is expected to be complete by the end of 2026. Where COMP360 stands.

Sources

  1. The White House, "Accelerating Medical Treatments for Serious Mental Illness," Executive Order 14401, April 18, 2026. whitehouse.gov
  2. Associated Press via ABC7, "Trump signs executive order to speed review of psychedelics, including controversial drug ibogaine," April 2026. abc7news.com
  3. Petrie-Flom Center, Harvard Law School, "A New Executive Order on Psychedelics: Q&A with I. Glenn Cohen and Mason Marks," April 18, 2026. petrieflom.law.harvard.edu
  4. Managed Healthcare Executive, "FDA grants priority vouchers to 3 psychedelic medications," April 2026. managedhealthcareexecutive.com
  5. U.S. Department of Health and Human Services, HHS and VA partnership on psychedelic therapies for veterans, July 2026. hhs.gov
  6. U.S. Food and Drug Administration, public hearing on potential future therapeutic use of psychedelic drugs, September 14, 2026. fda.gov
  7. Foley Hoag, "FDA Holds Landmark Public Hearing on the Future Therapeutic Use of Psychedelic Drugs," September 2026. foleyhoag.com