Public Citizen petitions US FDA to amend generic drug labeling regulations in the wake of Mensing

The US Food and Drug Administration should revise its regulations to allow generic drug manufacturers to update product labeling to warn patients about risks associated with their drugs, consumer advocacy group Public Citizen said in a petition sent to the agency this week.

Under current FDA regulations, generic drugmakers cannot update their products’ labeling, even if they become aware of a potential risk not stated in the labeling. In contrast, brand-name drug manufacturers can update warnings and precautions on product labeling before getting FDA approval. The generic drugmaker is required to match its labeling to brand-name labeling.

The illogical disparity between labeling regulations for generic companies and brand-name companies was highlighted in a June 2011 decision of the US Supreme Court. In Pliva versus Mensing, the court relied on FDA regulations as the basis for its holding that patients harmed by inadequate warnings on a generic drug cannot sue the drugmaker for damages, while people who take brand-name version of the same drug can. This “absurd consequence,” to quote Justice Sonia Sotomayor, turned on the fact that FDA regulations do not allow generic manufacturers to alter their labeling, even when they become aware that it is inadequate, Public Citizen pointed out.