Legal analysis assails FDA's lowering of standards for drug approval

The Food and Drug Administration's (FDA's) announcement last fall that it intends to approve a new indication for the folic acid derivative leucovorin signals a dangerous departure from long‐held evidentiary standards for drug approval, a group of legal and bioethics experts suggested in a published commentary. The authors wrote that the FDA has moved to approve leucovorin for some patients with autism despite having no evidence of benefit from any randomized controlled trial. Their viewpoint article was published online Dec. 22, 2025 in JAMA .