Food and Drug Administration Petition on Generic Drug Labeling
PLIVA v. Mensing
August 29, 2011, updated November 11, 2013
View the petition (PDF).
View FDA’s response to the petition (PDF).
View the proposed rule (PDF).
View press release.
In August 2011, Public Citizen petitioned the Food and Drug Administration (FDA) to revise its regulations to allow generic drug manufacturers to update product labeling to warn patients about newly discovered risks associated with their drugs. Such revisions would cure the illogical disparity between labeling regulations for generic companies and brand-name companies, as brands are permitted to promptly revise drug labeling to provide updated safety information.
The inability of generic companies to revise labeling poses a safety problem because safety issues often arise years after the generic version of a drug has entered the market – sometimes more than a decade later. For example, as Public Citizen explained in a report issued in June 2013, at least 53 drugs approved by the FDA more than 10 years ago have required new black-box warnings over the past five years.
In November 2013, the FDA granted our petition and issued a proposed rule that, when finalized, would establish procedures for generic drug manufacturers to change product labeling to reflect new information in advance of FDA's review of the change. As the FDA explained, the proposed rule will improve the communication of important drug safety information about generic drugs to both prescribers and patients.