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 Medicines, a generic medicines lobby group.

The accelerated process will give doctors additional justification to prescribe the drug for cerebral folate deficiency, a metabolic disorder that can lead to a range of neurological symptoms including some associated with autism, delivering on Kennedy’s promise to President Donald Trump and the “Make America Healthy Again” movement with which he is aligned.

Without robust evidence, the label change represents at most a hollow bureaucratic victory, said Ameet Sarpatwari, a pharmaceutical policy researcher at Harvard Medical School.

However, the drug, which is used to mitigate toxic........

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