A Case at a Crossroad: United States ex rel. Franklin v. Parke-Davis and the Intersection of Regulating Promotion of Off-Label Uses and Medicaid Fraud and Abuse

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A Case at a Crossroad: United States ex rel. Franklin v. Parke-Davis and the Intersection of Regulating Promotion of Off-Label Uses and Medicaid Fraud and Abuse

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Alperowicz, Maya en_US
dc.date.accessioned 2012-06-07T20:36:56Z
dc.date.issued 2004 en_US
dc.identifier.citation A Case at a Crossroad: United States ex rel. Franklin v. Parke-Davis and the Intersection of Regulating Promotion of Off-Label Uses and Medicaid Fraud and Abuse (2004 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852173
dc.description.abstract In United States ex rel. Franklin v. Parke-Davis, a former employee of a pharmaceutical manufacturing company alleged violations of the federal False Claims Act stemming from the company’s promotion of an FDA-approved drug for an unapproved use. The suit presented a novel legal claim that brought together two otherwise distinct elements of food and drug law – the regulation of promotion of off-label uses of approved drugs and the prosecution of Medicare and Medicaid fraud and abuse via the federal False Claims Act. This paper examines individually each of these areas of food and drug law and then turns to the conjunction between the two created by the lawsuit. The paper concludes with a discussion of the potential policy ramifications of a decision in United States ex rel. Franklin v. Parke-Davis. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject FDA en
dc.subject false claims act en
dc.title A Case at a Crossroad: United States ex rel. Franklin v. Parke-Davis and the Intersection of Regulating Promotion of Off-Label Uses and Medicaid Fraud and Abuse en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-07T20:36:56Z

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