FDA Fast-Tracks Three Psychedelic Treatments After Trump Order
FDA granted priority reviews to two psilocybin programs and one methylone program and cleared a noribogaine trial following a presidential executive order.
ReasonThe FDA Fast-Tracks Its Review of Psilocybin and Methylone, 2 Promising Psychedelics
Scientific AmericanRFK, Jr., puts psychedelics on fast track to FDA review and approval
CNBCFDA fast-tracks psychedelic drug research following Trump executive order
Washington ExaminerFDA fast-tracks psychedelic drug research per Trump's request
Overview
The FDA said Friday it will grant ultra-fast priority reviews to three experimental psychedelic therapies, covering two psilocybin programs and one methylone program.
President Donald Trump signed an executive order directing federal agencies to speed research and loosen restrictions on psychedelics, spurring the FDA action.
FDA Commissioner Marty Makary and HHS Secretary Robert F. Kennedy Jr. said the measures aim to accelerate treatments for hard-to-treat mental illnesses, with veterans advocating for access.
Compass Pathways and Usona Institute received expedited reviews for psilocybin, Transcend Therapeutics got a priority voucher for methylone, and DemeRx NB won clearance to study noribogaine.
Makary said decisions could come as soon as this summer or fall, and officials emphasized that expedited review does not guarantee approval and that safety data will be closely monitored.
Analysis
Center-leaning sources frame the story as pro-innovation and urgent by using positive evaluative language (e.g., "promising," "dramatic," "ultra-fast"), foregrounding industry and advocacy voices while omitting skeptical experts, and emphasizing the administration's acceleration—creating a narrative of rapid benefit without discussing safety, limits of evidence, or opposing viewpoints.