U.S. Health Secretary Robert F Kennedy Jr. could deliver a policy win for the Trump administration in just a few months after the Food and Drug Administration enlisted GSK to help it fast-track approval of a decades-old drug to treat an autism-related disorder.

The FDA’s unusual move will allow it to bypass a lengthy label update for generic versions of the drug, leucovorin, or new clinical trials, a tactic academics, lawyers and doctors questioned.

A GSK spokesperson told Reuters it plans to complete the new use application for the branded version of leucovorin “as quickly as possible.”

Once the British drugmaker does that work, the FDA would normally take about four to six months but could process the request even faster, said Giuseppe Randazzo of the Association for Accessible Medici

See Full Page