August 29, 2011, updated December 13, 2018
View testimony of Allison Zieve, Director of Public Citizen Litigation Group before the Committee on Energy and Commerce, Subcommittee on Health, U.S. House of Representative, March 3, 2014. (Postponed to April 1)
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.
On December 13, 2018, the FDA announced that it will withdraw its November 2013 proposed rule. View Public Citizen’s press statement reacting to the FDA’s action.