FDA Preemption After the Food and Drug Amendments Act of 2007

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FDA Preemption After the Food and Drug Amendments Act of 2007

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dc.contributor.advisor Peter Hutt en_US
dc.contributor.author Hicks, Kristin
dc.date.accessioned 2012-04-18T16:09:30Z
dc.date.issued 2008
dc.identifier.citation Kristin Hicks, FDA Preemption After the Food and Drug Amendments Act of 2007 (May 2008). en_US
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8592147
dc.description.abstract Opposing the explosive rise in tort litigation in the last two decades has been a corresponding rise in federal preemption claims. In the FDA context, the controversy has largely surrounded the issue of whether federal law preempts state common-law “failure-to-warn” claims against drug and medical-device manufacturers. During the current Bush Administration, FDA changed its position regarding preemption of state tort law claims and for the first time asserted that that compliance with FDA-mandated labeling provisions preempts common law failure-to-warn claims. The changed position attracted considerable attention in the academic and legal community, and the preemption debate has consequently become one of fiercest battles in products liability litigation today. Indeed, the Supreme Court is scheduled to hear a case next Term addressing preemption of products liability claims against drug manufacturers. Any decision addressing preemption of drug-based products liability claims will have to consider the impact of the recent Food and Drug Amendments Administration Amendments Act of 2007 (“FDAAA”). This Act significantly expands FDA’s enforcement and surveillance powers, provides a framework for post-market risk identification, and expands the requirements for clinical trials registration and disclosure of results, among other provisions. This Paper therefore examines the impact of the FDAAA on FDA’s preemption claims and concludes that by strengthening FDA’s powers, the FDAAA may also have strengthened FDA’s claim for preemption. By increasing the FDA’s ability to effectively regulate drug efficacy and safety, the FDAAA put the agency on stronger ground when claiming ultimate authority over drug labeling. en_US
dash.license LAA
dc.subject food and drug law en_US
dc.subject Relation of Food and Drug Law Act to State Laws-Federal Preemption en_US
dc.subject.other Food and Drug Law en_US
dc.title FDA Preemption After the Food and Drug Amendments Act of 2007 en_US
dc.type Paper (for course/seminar/workshop) en_US
dc.relation.journal Food and Drug Law: An Electronic Book of Student Papers en_US
dc.date.available 2012-04-18T16:09:30Z

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