FDA withdraws proposed rule that would have exposed generic-drug makers to liability

FDA on Thursday withdrew a proposal that would have opened up generic companies to possible product-liability lawsuits over drug safety. The agency had proposed a new federal rule in 2013 that would have allowed people to hold generic-drug companies legally liable for the side effects of medicines.

FDA on Thursday withdrew a proposal that would have opened up generic companies to possible product-liability lawsuits over drug safety. The agency had proposed a new federal rule in 2013 that would have allowed people to hold generic-drug companies legally liable for the side effects of medicines. Thursday's action by the agency keeps generic companies largely impervious to lawsuits. At issue is whether generic-drug companies are allowed, like brand-name drug companies, to change their drug labels to reflect new safety concerns. Currently, generic-drug companies must follow the labels written by the brand-name companies. FDA Commissioner Scott Gottlieb and the agency's drug-center director Janet Woodcock said in a statement, "We heard from manufacturers that they believed this change would have imposed on them significant new burdens and liabilities" and that the measure "might have raised the price of generic drugs to patients."