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Trump Signs Executive Order to Expedite Psychedelic Drug Review and Reclassification
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Trump Signs Executive Order to Expedite Psychedelic Drug Review and Reclassification

Apr 18, 2026

President Trump signed an executive order Saturday directing the FDA to expedite reviews of psychedelic drugs including psilocybin for PTSD, depression, and trauma, with the DEA and Justice Department beginning rescheduling reviews after successful phase-three trials. The order provides $50 million in state funding for psychedelic treatment programs and allows terminally ill patients to access these drugs through right-to-try legislation. FDA chief Marty Makary announced three priority review vouchers for serotonin 2a agonist psychedelics, with decisions expected by summer 2025. The order, written in less than a week according to Mehmet Oz, followed a text from Joe Rogan about ibogaine research and aims to create pathways for substances previously deemed unlikely for approval due to safety concerns.

Executive Order Provisions and Regulatory Changes

  • ▪Nora Volkow said in 2024 that ibogaine was unlikely to receive approval because of concerns about cardiac side effects
  • ▪Administration officials vetoed a fast-track approval process for a psilocybin treatment from Compass Pathways earlier in 2025
  • ▪Marty Makary announced three priority review vouchers would be given to three serotonin 2a agonist psychedelics next week
  • ▪The executive order provides $50 million in funding for states developing programs to further psychedelic treatments for mental illness

Rapid Policy Development Process and Presidential Influence

  • ▪President Trump was flanked by Morgan Luttrell, Marcus Luttrell, other veterans, and top health officials at the executive order signing ceremony
  • ▪Mehmet Oz said President Trump would not take no for an answer regarding the psychedelic executive order
  • ▪Jay Bhattacharya leads the National Institutes of Health and is currently the top official at the Centers for Disease Control and Prevention
  • ▪President Trump responded to Joe Rogan's text about ibogaine by saying "Sounds great. Do you want FDA approval? Let's do it."
  • ▪Joe Rogan texted President Trump about research around ibogaine

Industry and Advocacy Response to Psychedelic Access Expansion

  • ▪Mehmet Oz said the Center for Medicare and Medicaid Innovation was considering new models to cut down prices for psychedelic treatments
  • ▪Rob Barrow said nothing about the executive order should lower the bar or requirements for getting drugs approved and reviewed
  • ▪Kabir Nath is CEO of Compass Pathways, which develops psychedelic therapies
  • ▪Jon Kostas is executive director of the Association for Prescription Psychedelics
  • ▪Mehmet Oz said a pricing model for psychedelic treatments could be announced by the end of 2025
  • ▪Rob Barrow is CEO of Definium Therapeutics, a company developing psychedelic therapies

Perspective of Trump administration health officials

  • ▪Mehmet Oz said the Center for Medicare and Medicaid Innovation was considering new models to cut down prices for psychedelic treatments
  • ▪Mehmet Oz said President Trump would not take no for an answer regarding the psychedelic executive order

3 sources

Statnews
How Trump is pushing psychedelics reform through the health agencies
View source article
Artthreat
Executive order directs FDA to expedite psychedelic drug review - Art Threat
View source article
Washingtontimes
Trump signs order to expedite medical psychedelic drug treatment, research
View source article

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United States

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Donald Trump

Topics

PsilocybinPsychedelics for PTSDPsychedelic clinical research & trialsPsychedelics for depressionPsychedelic policy & regulationMental health

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