FDA contradicts Trump administration, refuses to approve generic autism drug

In September, the Trump administration took what it called “bold steps” against autism, including promoting the generic drug leucovorin as a promising treatment. In a press release, Marty Makary, commissioner of the Food and Drug Administration, stated that “growing body of evidence suggests “the drug could be helpful. And at a White House press event, Makary suggested it could help.”20, 40, 50 percent of children with autism.”

“Hundreds of thousands of childrenIn my opinion, it 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 leucovorin prescriptions for children ages 5 to 17 skyrocketed 71 percent in the three months following the Trump administration’s actions.

But today it became clear that the rest of the FDA did not share the views of Makary and other administration officials. In an announcement, the regulatory agency said it had Leucovorin approved for rare genetic condition—but not for autism.

In comments to the Associated Press, senior FDA officials said They found little evidence to expand the use of the drug to autism and therefore limited its review to the treatment of a rare genetic condition, which is adult brain folate deficiency (CFD) caused by a genetic mutation in the folate receptor 1 (CFD-FOLR1) gene.