INNsight article by Alan Klein

On June 23, the U.S. Supreme Court in a closely-watched appeal, PLIVA, Inc. v. Mensing, found that failure-to-warn claims brought under state law by plaintiffs experiencing adverse events from generic drugs could not bring or pursue those claims under the U.S. Constitution.    Following oral argument, and after reviewing briefs submitted by the litigants and friend-of-the court briefs received from medical professionals, law professors, the Generic Pharmaceutical Association and many others, the Supreme Court concluded that federal law requires that generic drug labeling must remain “the same as” the brand or innovator drug’s label at all times both before and following the FDA’s approval of a generic’s ANDA. Generic drug label changes are not permitted, the Court said, because there are no regulations permitting generics to strengthen or otherwise modify drug labeling unless the FDA approves a label change for  the brand drug.  Because under the Supremacy Clause of the Constitution federal law supersedes and takes precedence over conflicting state law, state laws that mandate generic drug companies to strengthen or otherwise modify label warnings are preempted and unenforceable.

The 1984 Hatch-Waxman Amendments to the U.S. Food, Drug and Cosmetic Act permit generics to enter the marketplace on a fast-track provided their ANDAs establish the bioequivalency of their drugs to those of the reference listed manufacturer or innovator.  Safety and efficacy of the RLD (reference listed drug) is not only established when the innovator receives its initial FDA marketing approval,  it is often reconfirmed over decades of the innovator’s patent exclusivity period. These findings furnish assurances to the FDA and the public that generic drugs replicating the brand  are equally safe and effective. 

Key to the Court’s decision were concessions made by the federal agency in charge of U.S. drug regulation, the FDA, participating in the appeal as a friend-of-the-court, confirming the absence of any regulatory mechanism for generics to suggest or implement stronger warnings or other label changes on their own initiative.  Brand drug manufacturers, on the other hand, have the authority under the FDA’s “Changes Being Effected” (CBE) regulations to independently make and effectuate label changes, subject to the FDA’s ultimate approval.  Generics have never had this ability under the agency’s regulatory system.

The Supreme Court in Mensing, noting the existence of two separate regulatory schemes for brand and generic manufacturers, refused to squeeze a square peg into a round hole by permitting plaintiffs to bring failure-to-warn lawsuits against generics when generics had no legal option but to use the brand drug’s labeling at all times.