Public Citizen recently submitted a citizen petition to the Food and Drug Administration, calling on the agency to adopt rule changes that would allow generic drug makers to change their products’ approved labels more expeditiously. According to the petition, “while [generics’] market shares have increased, the regulatory system has not adjusted to compel generic manufacturers to shoulder responsibility commensurate with their status as major market players,” and “the rise of generics has weakened incentives for brand-name manufacturers to remain actively engaged in the market for their products after losing patent protection.” Patient safety is threatened, says Public Citizen, because brand-name manufacturers do not invest resources in postapproval safety monitoring as generic market share increases, “while generic manufacturers face no concomitant increase in incentive and have no authority to update labeling.”
The petition was filed in the wake of a U.S. Supreme Court determination that federal rules requiring that generic drug makers use the same information on product labels as their name-brand counterparts preempt state common-law claims failure to warn involving generics. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). Public Citizen also notes that the product liability law of many states immunizes brand-name companies from liability for harm caused by inadequate labeling where the injured patient took a generic form of the drug. The advocacy organization’s proposal would authorize generic drug makers to use the same procedures that brand-name manufacturers use to gain approval for updated product warnings based on new information.