The AP (3/10, Perrone) reports that on Tuesday, the FDA “approved a generic medication for a rare brain disorder, while walking back statements by” the President “and other administration officials that the drug showed great promise for people with autism.” The FDA “said it approved leucovorin for children and adults with a genetic condition that limits delivery of folate, a form of vitamin B, to the brain.” It is “a major step back from comments made at a White House news conference in September, when” the President “and FDA commissioner Marty Makary announced the drug was under review to benefit patients with autism, some of whom have a form of the vitamin brain deficiency.” Senior agency “officials told reporters Monday that their review was narrowed to focus on the strongest evidence, which only supported the drug’s use by patients with the rare mutation that impacts folate levels in the brain.”
CNN (3/10, Goodman) reports that Tuesday’s “update on leucovorin may hit some families of children with autism especially hard.” In the months since the September briefing, “leucovorin prescriptions surged, making the drug hard to find.”
Related Links:
— “FDA finds little evidence that a drug touted by Trump can help people with autism,”Matthew Perrone , AP, March 10, 2026