Government Regulation of Off-Label Drug Prescriptions: Balancing Healthcare Innovation with Public Safety and Fiscal Responsibility

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Government Regulation of Off-Label Drug Prescriptions: Balancing Healthcare Innovation with Public Safety and Fiscal Responsibility

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Kelly, Carly en_US
dc.date.accessioned 2012-06-07T20:04:43Z
dc.date.issued 2004 en_US
dc.identifier.citation Government Regulation of Off-Label Drug Prescriptions: Balancing Healthcare Innovation with Public Safety and Fiscal Responsibility (2004 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852095
dc.description.abstract This paper examines the government’s role in regulating off-label drug prescriptions, both as a patient safety advocate and as a health insurer. Part One describes why off-label drug prescriptions occur, including an analysis of the risks and benefits of this practice. Part Two examines how FDA drug marketing regulations, Medicare and Medicaid reimbursement rules, and healthcare fraud and abuse laws have shaped the current landscape of off-label prescription policies. Finally, Part Three proposes regulatory reforms that could help the government to better achieve its goal of encouraging drug treatment innovation, while still protecting the public from the medical and fiscal harms of inappropriate and excessive off-label drug prescriptions. 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 prescription drug regulation en
dc.title Government Regulation of Off-Label Drug Prescriptions: Balancing Healthcare Innovation with Public Safety and Fiscal Responsibility en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-07T20:04:43Z

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