"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."
"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 effects of certain cancer treatments and sells for $34.14 for a bottle of 30 high-dose pills on Cost Plus Drugs, would more likely be covered for the condition by insurance plans with the label change."
FDA enlisted GSK to fast-track approval of leucovorin for an autism-related indication, enabling the agency to bypass lengthy generic label updates or new trials. GSK will prepare the new use application for the branded product, after which the FDA could act within four to six months or sooner. The accelerated pathway could give clinicians stronger justification to prescribe leucovorin for cerebral folate deficiency, a metabolic disorder linked to neurological symptoms including some associated with autism. Critics warn the label change may be a hollow victory absent robust evidence. HHS asserted that evidence supports leucovorin’s effectiveness, and demand has risen after media and presidential promotion.
Read at Fast Company
Unable to calculate read time
Collection
[
|
...
]