The U.S. Food and Drug Administration (FDA) has filed a notice with the Office of Management and Budget indicating its intent to initiate a rulemaking that would “revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA’s review of such change.” According to FDA, the proposed revisions “would create parity” between brand-name and generic drug makers as to how they update their product labels.
Recent U.S. Supreme Court rulings have largely insulated generic drug makers from liability for state law-based inadequate labeling claims, because under current regulations they have no way to change their labels to reflect changes in understanding about potential risks. Rather, generic drug manufacturers must use the same label warnings as those provided by their brand-name counterparts.
An FDA spokesperson reportedly indicated that it would be “premature to cite what changes in the regulations might be,” noting that FDA had indicated in the past that it would consider a rule change. Public Citizen Health Research Group senior adviser Sidney Wolfe welcomed the development, saying “It’s common sense. It will obviously end this situation where people are being harmed physically and yet, although they are harmed, they have no right to go into court and get redress for serious damages.” Public Citizen filed a petition with FDA in 2011 seeking parity in drug-labeling requirements. See The New York Times, July 3, 2013.