New Bill Would Let Generics Makers Update Own Labels

Law360, New York (April 18, 2012, 11:14 PM EDT) -- Democratic legislators in both houses of Congress introduced legislation Wednesday that would reverse a recent U.S. Supreme Court decision by allowing generic-drug makers to independently change their labels to include new risks or side effects.

The lawmakers said the Patient Safety and Drug Labeling Improvement Act addresses an inconsistency in the law laid bare in the high court’s 2011 decision in Pliva v. Mensing, in which the Supreme Court held that state-law tort claims against generics manufacturers were preempted because the Hatch-Waxman Amendments require generics to...
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