Dems Introduce Label-Change Bill for Generic-Drug Makers

Democrats in the House and Senate have introduced companion bills that would allow generic-drug makers to update safety warnings on labeling without waiting for the brand drugmaker to do it first. The Patient Safety and Drug Labeling Improvement Act (S. 2295 and H.R. 4384) could strip generic makers of their freedom from liability for safety labeling issues, affirmed by the Supreme Court last summer. In Pliva v. Mensing, the High Court found generic companies cannot be held liable for not listing adverse events that aren’t listed in the brand drug’s label.
Washington Drug Letter