The Trump administration’s 2026 executive order aims to fast-track psychedelic therapies by prioritizing breakthrough drugs, expanding patient access, and accelerating FDA reviews, drawing strong support from companies like Compass Pathways.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
In April 2026, President Donald Trump signed the executive order “Accelerating Medical Treatments for Serious Mental Illness,” directing federal agencies to remove barriers to psychedelic‑assisted treatments for serious mental illness.
The order explicitly recognizes that the FDA has granted Breakthrough Therapy designation to certain psychedelic drugs and instructs the FDA Commissioner to prioritize reviews of those candidates, including via National Priority (Commissioner’s) Vouchers, to accelerate approvals.
The policy directs the FDA and the Drug Enforcement Administration to establish a pathway allowing eligible patients with serious or treatment‑resistant conditions to access investigational psychedelic drugs such as ibogaine and related compounds under expanded “Right to Try”–type mechanisms, once basic safety criteria are met.
It also requires the Secretary of Health and Human Services to allocate at least $50 million through ARPA‑H to support and match state‑level psychedelic research programs for serious mental illnesses, and to coordinate with the Department of Veterans Affairs and the private sector to expand clinical trials and generate real‑world evidence.
The Attorney General is instructed to initiate rescheduling reviews for psychedelics upon successful completion of Phase 3 trials, so that rescheduling can proceed promptly after FDA approval where appropriate. This creates a more cohesive pathway from clinical development to patient access, especially for veterans with PTSD, depression, and high suicide risk, while stopping short of nationwide legalization.
Compass Pathways has publicly welcomed the order, highlighting its lead candidate, COMP360 (a synthetic psilocybin formulation), which already holds Breakthrough Therapy designation and is in Phase 3 development. The company emphasizes that the directive aligns with its ongoing regulatory discussions and positions it to benefit from faster FDA review timelines and potential early‑access routes, while underscoring clinical data suggesting rapid onset and sustained benefit after limited dosing.
“Corey Keller, an associate professor of psychiatry and neurotech leader at Stanford, called the executive order ‘a meaningful moment for our field, and for the patients who need better options,’ while also underscoring the importance of rigorous clinical frameworks as the pipeline grows.”
Kabir Nath, CEO at Compass Pathways welcomed the move but explicitly stressed that accelerated timelines should not come at the expense of robust evidence, noting that their work with the FDA continues to prioritize “rigorous science” alongside faster access.
At the same time, legal and policy analysts have highlighted that the order’s reliance on accelerated‑review tools and expanded Right‑to‑Try–style pathways will require careful post‑approval monitoring to ensure that safety and long‑term efficacy data keep pace with policy‑driven speed.
Reference
Accelerating Medical Treatments for Serious Mental Illness – The White House
About the Writer
Nikita Jha, BPharm a pharmacy graduate specializing in medical writing, with a strong ability to interpret complex medical and regulatory information and translate it into clear, accurate, and evidence-based healthcare content. Known for her attention to detail and precision, she focuses on delivering high-quality scientific communication that supports drug safety and informed decision-making.
