Supreme Court Nixes Labeling Suits Against Generic-Drug Makers

Generic-drug makers claimed victory June 24 when the U.S. Supreme Court ruled they can’t be held responsible for failing to list adverse events not included in the brand drug’s label. In a 5-4 vote, the justices accepted generic-drug makers’ argument that they have a federal requirement to mirror the labels of reference listed products, as mandated in the Hatch-Waxman Act.
International Pharmaceutical Regulatory Monitor