FDA Supports Solicitor General in Generic Preemption Case

December 3, 2010
Federal regulations do not categorically preempt a plaintiff’s “failure-to-warn” claims against generic drugmakers, because manufacturers are obligated to inform the FDA of risks that may warrant a labeling change, the agency says. In a brief filed with the U.S. Court of Appeals for the Sixth Circuit, the FDA says that although generic companies are prohibited from effecting changes to the labeling of their products that diverge from the brand label, they can ask the agency to coordinate appropriate warning letters to physicians or take other steps to address labeling concerns.
Washington Drug Letter