Generic Manufacturers’ Labeling Catch-22

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dc.contributor.author Lee, Stacey
dc.date.accessioned 2011-03-24T14:34:21Z
dc.date.available 2011-03-24T14:34:21Z
dc.date.issued 2011
dc.identifier.uri http://jhir.library.jhu.edu/handle/1774.2/34784
dc.description.abstract 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. en
dc.description.provenance Submitted by Rashawna Sydnor (rsydnor@jhu.edu) on 2011-03-24T14:34:21Z No. of bitstreams: 1 SBLee Catch-22.pdf: 565513 bytes, checksum: af7dc159b6b7a463b1c23139b47950b1 (MD5) en
dc.description.provenance Made available in DSpace on 2011-03-24T14:34:21Z (GMT). No. of bitstreams: 1 SBLee Catch-22.pdf: 565513 bytes, checksum: af7dc159b6b7a463b1c23139b47950b1 (MD5) Previous issue date: 2011 en
dc.language.iso en_US en
dc.relation.ispartofseries Teh Johns Hopkins Carey Business school Working Paper Series;11-03-001
dc.subject K2 en
dc.subject Generics, Preemption, Drug Labeling Regulatory Framework en
dc.title Generic Manufacturers’ Labeling Catch-22 en
dc.type Working Paper en

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