Off-Label Use of Prescription Drugs should be Regulated by the FDA

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Off-Label Use of Prescription Drugs should be Regulated by the FDA

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Tiwary, A Devesh en_US
dc.date.accessioned 2012-06-07T20:28:10Z
dc.date.issued 2003 en_US
dc.identifier.citation Off-Label Use of Prescription Drugs should be Regulated by the FDA (2003 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852151
dc.description.abstract The FDA does not subject all uses of drugs to a rigorous approval process. There are many justifications given for this. I lay out a system that divides drug-indication sets into four categories: (1) FDA approved; (2) effective; (3) insufficient information; and (4) ineffective. Each category is treated differently so manufacturers have an incentive to get as many indications into the FDA approved category as possible. Physicians will be required to submit de-identified patient data and when prescribing drugs for indications that have insufficient data. They, or their patients, may not be reimbursed for that care unless it is part of a study. My system saves money, improves health care, and advances medical knowledge at the cost of decreased physician autonomy and possibly slightly higher regulatory cost to drug manufacturers. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Administrative law en
dc.subject off-label en
dc.subject prescription en
dc.subject drugs en
dc.subject regulation en
dc.subject FDA en
dc.title Off-Label Use of Prescription Drugs should be Regulated by the FDA en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-07T20:28:10Z

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