Fda's Authority Does Not Preempt State Law, Supreme Court Rules In Wyeth V. Levine

摘要

In a ruling that reduces the FDA's drug-labeling authority from one of potentiallyrnpreemptive power to one that merely sets a floor, which state courts and juries presumably may revise as individual cases arise, the Supreme Court's decision in Wyeth v. Levine places primary responsibility for adequate labeling on drugmakers.rnThe justices ruled 6-3 last week that neither the Food, Drug and Cosmetic Act (FDCA) nor FDA regulations preempt Diana Levine's state-law claim that labeling for Wyeth's anti-nausea drug Phenergan (promethazine HC1) lacked an adequate warning of the risk of developing gangrene from IV-push injection of the product. Furthermore, the court said the company was not prohibited by federal law or regulation from unilaterally adding or strengthening information on the Phenergan label, as the company had contended.