#fda-policy

#fda-policy

At a press conference in late 2025, federal officials made some big claims about leucovorin, a prescription drug usually reserved for people on cancer chemotherapy. "We're going to change the label to make it available [to children with autism spectrum disorder]," said Dr. Marty Makary, commissioner of the Food and Drug Administration. "Hundreds of thousands of kids, in my opinion, will benefit." The FDA still hasn't made that label change. Since Makary's remarks, though, more than 25,000 people have joined a Facebook group called Leucovorin for Autism. Most members appear to be parents seeking the drug for their autistic children.

This year, the White House has broadcast its intent to greatly reduce animal experimentation in the United States. In early April, the Food and Drug Administration announced that it would require less testing on animals for the development of a widely used class of drugs-an approach, the agency says, that should speed up the drug-development process and eventually lower drug prices.

Women should not suffer through menopause with hot flashes, night sweats and poor sleep. That's the message from FDA Commissioner Dr. Marty Makary. The agency announced it will remove "black box" warning labels from estrogen-based hormone therapy, which treat the symptoms of menopause, saying the warnings have made women scared to try the therapy and doctors reluctant to prescribe it.