FDA contradicts Trump admin, declines to approve generic drug for autism

In a surprising turn of events, the FDA has chosen not to approve the use of the generic drug leucovorin for treating autism, despite earlier claims from the Trump administration that it could be beneficial. In September, officials heralded leucovorin as a groundbreaking treatment option, citing a "growing body of evidence" suggesting its effectiveness. Marty Makary, the commissioner of the FDA at the time, stated that it could potentially help a significant percentage of children with autism, claiming that “hundreds of thousands of kids, in my opinion, will benefit.” Following these assertions, a study published in The Lancet indicated a remarkable 71 percent increase in new prescriptions of leucovorin for children aged 5 to 17 within three months after the administration's announcement. However, the FDA's current stance contradicts the earlier optimism expressed by Makary and others. In a recent announcement, the agency confirmed it had approved leucovorin for treating a rare genetic condition known as cerebral folate deficiency (CFD), but explicitly excluded its use for autism. Senior officials at the FDA explained to the Associated Press that their decision was based on a lack of substantial evidence supporting the expansion of leucovorin's application to autism treatment. As a result, their focus has now shifted solely to its use for CFD, which is linked to a genetic mutation affecting the folate receptor 1 gene.