Trump signs executive order fast-tracking psychedelic therapies

President Trump signed an executive orderExecutive OrderA written directive from the President directing federal agencies to implement or change policy without requiring congressional approval.Key ConceptExecutive OrderA written directive from the President directing federal agencies to implement or change policy without requiring congressional approval.Open conceptBookmark at the Resolute Desk on April 18, 2026 directing the FDA to accelerate approval of psychedelic therapies for veterans and patients with treatment-resistant mental health conditions. The order specifically targets psilocybin, MDMA, and ibogaine. FDA Commissioner Marty Makary is instructed to issue three priority review vouchers next week for drugs targeting serotonin 2a receptors, which would cut the standard FDA review timeline from 10 months to six months.

Priority review vouchers don't guarantee approval. They only speed up the timeline for FDA to make a decision. The vouchers are also transferable and can be sold to other pharmaceutical companies, creating a secondary market worth hundreds of millions of dollars per voucher. The order allocates $50 million in matching funds for psychedelic research programs at universities and VA hospitals.

The executive order opens the Right to Try pathway for ibogaine, a psychoactive substance derived from the iboga plant that's currently classified as Schedule I under the Controlled Substances Act. Ibogaine has shown promise in treating opioid addiction in small studies, but it carries serious cardiac toxicity risks. NIDA Director Nora Volkow has warned that ibogaine can cause fatal heart arrhythmias, and it hasn't completed the Phase 3 clinical trials normally required before patients can access experimental drugs.

The Right to Try Act, signed into law in 2018, was designed to let terminally ill patients access drugs that have completed Phase 1 trials but haven't received full FDA approval. Using it for ibogaine stretches the law's original intent. Texas enacted its own ibogaine research law in 2025 with $100 million in state funding, but that program requires clinical oversight and cardiac monitoring that the federal executive order doesn't mention.

The order was written in less than a week, according to CMS Administrator Mehmet Oz, who helped coordinate the policy. Podcast host Joe Rogan and Navy SEAL Marcus Luttrell both lobbied Trump directly for the order. Luttrell's brother, Rep. Morgan Luttrell (R-TX), has pushed psychedelic therapy legislation in Congress since 2023. Calley Means, a health policy adviser connected to both MAGA and MAHA political networks, also helped shape the executive order.

The speed of the order's drafting raises questions about whether standard interagency review processes were followed. Executive ordersExecutive OrdersPresidential orders directing federal agencies to implement policy or administrative changes.Key ConceptExecutive OrdersPresidential orders directing federal agencies to implement policy or administrative changes.Open conceptBookmark affecting drug scheduling typically involve review by the Office of Legal Counsel, the DEA, and the Department of Health and Human Services. CMS Administrator Oz's involvement is unusual because CMS handles Medicare and Medicaid reimbursement, not drug approval.

Legal scholars have challenged the president's authority to direct FDA approval decisions or compel the DEA to reschedule controlled substances. Mason Marks, Senior Fellow at Harvard's Petrie-Flom Center and POPLAR Lead, argues that existing statute already requires the DEA to reschedule a drug within 90 days of FDA approval. That means the executive order's rescheduling provisions don't add new legal authority. They just restate what the law already requires.

Glenn Cohen, faculty director of the Petrie-Flom Center at Harvard Law School, has noted that FDA independence is protected by the Federal Food, Drug, and Cosmetic Act. Presidents can set policy priorities, but they can't order the FDA to approve a specific drug. If the FDA grants approval based on political pressure rather than clinical evidence, the decision would be vulnerable to legal challenge under the Administrative Procedure Act.

Compass Pathways, a London-based psychedelic therapy company traded on NASDAQ, saw its stock rise 14% after the executive order was announced. The company's psilocybin therapy, COMP360, was denied fast-track designation by the White House in February 2026. This executive order reversed that decision just two months later. Compass CEO Kabir Nath called the order a "watershed moment" for psychedelic medicine.

Americans for Ibogaine, a nonprofit advocacy group, praised the Right to Try provisions. CEO W. Bryan Hubbard said the order would save thousands of veterans' lives. Rob Barrow, CEO of Definium Therapeutics, which is developing an ibogaine-derived compound, said his company's stock rose on the news. The financial interests of publicly traded psychedelic companies in the executive order raise questions about whether the policy was designed primarily for patient safety or market access.