Generic Drug Labeling Change Proposed by FDA is Significant and Will Likely Negate Preemption of State Failure-to-Warn Claims in Generic Drug Cases
Guest Post: Alina Denis Jarjour, Esquire, Jarjour | Legal
Under current law, an individual can bring a product liability action for failure to warn against a brand name drug company, i.e., the NDA (New Drug Application) holder, but generally not against a generic manufacturer, the holder of an ANDA (Abbreviated New Drug Application).
Federal preemption stems from FDA regulations that do not permit the holder of an approved ANDA to change labeling to add new safety information the generic company becomes aware of until and unless the brand name company that holds the NDA for the reference listed drug (RLD) modifies the labeling. This interpretation was affirmed by the U.S. Supreme Court in 2011 in the Pliva, Inc. […]