Two years ago the U.S. Supreme Court dismissed many “failure to warn” suits asserted against generic drug manufactures. Such “Failure to warn” suits verses generic drug makers will become viable if the FDA adopts a newly proposed rule. The FDA reports it now intends to require generic drug manufacturers change safety labeling on its drug containers. When a drug maker makes changes to labeling, the possibility for improper labeling occurs. Improper labeling gives rise to failure to warn suits. From the FDA’s viewpoint, the newly suggested rule would “create parity” between brand drugs and generic ones with regards to labeling requirements and updating.
As it is, brand drug makers must change label information after receiving significant new information concerning a drug. With the proposed change, generic drug manufacturers must also change label information as new safety concerns arise. The FDA’s intends to publish a proposed rule by September 2013 for public comment