Generic Manufacturers' Labeling Catch-22

39 Pages Posted: 8 Jul 2011 Last revised: 28 Jul 2013

See all articles by Stacey B. Lee

Stacey B. Lee

Johns Hopkins University - Carey Business School; Johns Hopkins University - Bloomberg School of Public Health

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

Lee, Stacey B., Generic Manufacturers' Labeling Catch-22 (July 7, 2011). Yale Journal of Health Policy, Law, and Ethics, Forthcoming, Available at SSRN:

Stacey B. Lee (Contact Author)

Johns Hopkins University - Carey Business School ( email )

100 International Drive
Baltimore, MD 21202
United States

Johns Hopkins University - Bloomberg School of Public Health ( email )

615 North Wolfe Street
Baltimore, MD 21205
United States

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