FDA Proposes Rule To Allow Generic Drugmakers To Change Labeling

Two years ago, the US Supreme Court ruled that generic drugmakers are not required to update product labeling, even when alerted to side effects, so long as the same change has not been made to the labeling for the branded medicine. The decision sparked an outcry that product labeling would be insufficient to warn patients about the risks associated with numerous medications. Now, the FDA has proposed a rule to revise regulations that prevent generic drugmakers from updating labeling, even if they become aware of a potential risk not mentioned in labeling. By contrast, brand-name drugmakers are currently allowed to update warnings and precautions in their labeling before obtaining FDA approval by submitting a “changes being effected” supplement. The proposed rule will allow generic drugmakers to update labeling with new safety information before an FDA review of the change. The agency would then evaluate whether the proposed change is justified and make an approval decision on the generic drug labeling change and the corresponding brand drug labeling change at the same time (here is the Federal Register notice). “This proposal will help ensure that health care professionals and consumers have access to the latest safety information for the medications they use,” Janet Woodcock, who heads the FDA Center for Drug Evaluation and Research, says in a statement. “More than 80 percent of prescriptions filled in the U.S. are for generics, so we want to make sure that generi...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs