FDA contradicts Trump admin, declines to approve generic drug for autism
In the end, the FDA only approved the drug for a rare genetic condition with clearer data.
In September, the Trump administration took what it called "bold actions" on autism that included touting the generic drug leucovorin as a promising treatment. In a news release, Marty Makary, commissioner of the Food and Drug Administration, claimed a "growing body of evidence suggests" the drug could be helpful. And at a White House press event, Makary suggested it might help "20, 40, 50 percent of kids with autism."
"Hundreds of thousands of kids, in my opinion, will benefit," he said at another point in the event.
The bold claims were apparently persuasive. A study published in The Lancet last week found that new outpatient prescriptions of leucovorin for children ages 5 to 17 shot up 71 percent in the three months after the Trump administration's actions.
This story was first published by Ars Technica. Read the original report