HHS rapid mental‑health actions
- HHS Rapid Response announced a package of federal moves to address the mental‑health crisis, spanning regulation and funding. - The statement named FDA prioritization of breakthrough therapies, expanded Right to Try, post‑Phase‑3 rescheduling, and $50M ARPA‑H for states. - It also flagged coordination with the DEA and VA as part of the federal response to crisis needs (x.com).
The Trump administration on April 18 ordered federal agencies to speed the review, testing and possible access to psychedelic drugs for serious mental illness. (whitehouse.gov) The White House said the order tells the Food and Drug Administration to prioritize qualifying psychedelic drugs that already have Breakthrough Therapy designation, a status for treatments that show early signs of substantial improvement over existing care. (whitehouse.gov) It also tells the Food and Drug Administration and the Drug Enforcement Administration to create a pathway for eligible patients to seek investigational psychedelic drugs under the 2018 Right to Try law, including ibogaine compounds under review. Under Food and Drug Administration rules, Right to Try applies to patients with life-threatening conditions who have exhausted approved options and cannot join a clinical trial. (whitehouse.gov) (fda.gov) The order also requires the Department of Health and Human Services to set aside $50 million through the Advanced Research Projects Agency for Health to match state spending on research programs for people with serious mental illness. It directs federal officials to work with the Department of Veterans Affairs and private-sector researchers to increase clinical-trial participation and evidence collection. (whitehouse.gov) A drug can reach the market only after the Food and Drug Administration finds it safe and effective, but many psychedelics also face a second barrier: federal drug scheduling. The White House said the order tells the attorney general to begin reviews after successful Phase 3 trials so any needed rescheduling can move quickly if the Food and Drug Administration later approves a product. (whitehouse.gov) The move lands in a mental-health system that still leans on long courses of medication and therapy, even for patients with treatment-resistant depression, post-traumatic stress disorder and addiction. In November 2025, the Advanced Research Projects Agency for Health announced a separate effort of up to $100 million to build better ways to measure whether fast-acting behavioral-health treatments are working. (arpa-h.gov) Federal officials framed the order around veterans as well as civilians. The White House said more than 14 million U.S. adults live with a serious mental illness, and CBS News reported Trump signed the order in the Oval Office alongside Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drug Administration Commissioner Marty Makary. (whitehouse.gov) (cbsnews.com) The order does not approve any psychedelic drug, legalize recreational use or bypass the Food and Drug Administration’s review standards. What it does is compress the federal steps around research, access and scheduling, with the first deadlines now set by an April 18 directive from the White House. (whitehouse.gov)
