Generic Manufacturers' Labeling Catch-22
39 Pages Posted: 8 Jul 2011 Last revised: 28 Jul 2013
Date Written: July 7, 2011
In Wyeth v. Levine, the Supreme Court eliminated brand-name manufacturers’ ability to use the preemption defense against state law failure to warn claims involving allegedly misbranded pharmaceutical drugs. Since that time, a heated debate has ensued among federal courts and legal scholars regarding that holding’s effect on generic manufacturers. Lost amid these judicial opinions and scholarly articles, however, is a more fundamental inquiry. Regardless of whether preemption is a viable defense, what type of legal and regulatory framework is needed to ensure generic manufacturers possess the necessary tools to fulfill their responsibility of providing consumers and the medical community with current and accurate labeling instructions for their products? This Article proposes such a framework.
Keywords: Pre-emption, generic drugs, FDA, Wyeth v. Levine, Pliva
JEL Classification: K32
Suggested Citation: Suggested Citation