Trump Orders FDA to Fast-Track Psychedelic Treatments

President Trump signed an executive order Saturday directing federal agencies to accelerate access to psychedelic drugs in clinical settings, framing the action as a response to what the order describes as a crisis of serious mental illness. The directive instructs the FDA to designate certain psychedelics as breakthrough drugs, fast-tracking their review, and expands access through right-to-try legislation, which permits terminally ill patients to use experimental treatments outside standard regulatory pathways. FDA Commissioner Marty Makary announced three priority review vouchers will be awarded next week to serotonin 2a agonists, a class of psychedelic compounds, with agency decisions expected later this summer. The executive order also directs a broader reevaluation of psychedelics' controlled substance classifications, a step that would carry significant legal and commercial consequences for the nascent psychedelic therapeutics sector. Investors and developers in that space will watch the FDA's summer timeline closely, as breakthrough designation and scheduling changes would materially alter the clinical and commercial runway for drugs in this pipeline.