Impossible? Outlawing state safety laws for generic drugs.

摘要

In the 2009 case Wyeth v, levine, the Supreme Court ruled that manufacturers of brand-name drags could be sued under state law for failing to adequately warn of new risks discovered after the drug was approved for marketing by the Food and Drug Administration (FDA). The Court rejected Wyeth's argument that state lawsuits were preempted because federal law prohibited the manufacturer from changing the label without FDA approval. The Court held, first, that Congress did not expressly forbid states from requiring additional safety warnings on drug labels. Second, the FDA had promulgated a "changes being effected" regulation, which explicitly permitted the drug manufacturer to make labeling changes to strengthen a warning without preapproval by the FDA. Finally, the Court noted, "it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the con-tent of its label at all times [including] . . . ensuring that its warnings remain adequate as long as the drug is on the market."