Judge Says FDA Permits Change in Generic Labels, Refuses Preemption Bid

NEW ORLEANS - Generic drug manufacturers can strengthen their warning labels without violating FDA rules, which prevent such changes only during the initial approval process for the drug, a federal judge has held in rejecting the drug maker's argument that claims against the company are preempted by federal law. Demahy v. Wyeth Inc., et al., No. 08-3616 (E.D. La.).

Judge Carl J. Barbier said Oct. 28 that all pronouncements against generic label changes that drug maker Actavis cited in support of its pro-preemption position were taken out of context and don't apply to drugs that have already proceeded through the …