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

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

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 governmentâ€™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