Anti-Mensing Bill Could Topple FDA's Generics Framework

Law360, New York (April 20, 2012, 7:37 PM EDT) -- A proposed bill that would allow generic-drug makers to change their own safety labels — an effort to open generics companies to failure-to-warn suits after the Supreme Court found last year that such suits are preempted — could undermine the entire regulatory system for generics, experts say.

The bill seeks to address what its lead sponsor, Sen. Patrick Leahy, D-Vt., calls a “troubling inconsistency” opened up by the court's decision in Pliva v. Mensing. Plaintiffs can no longer sue generic drugmakers for product liability claims tied...
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