The Military’s Need For “Speed”: A Case Study On The FDA’s Regulation Of Off-Label Prescriptions

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The Military’s Need For “Speed”: A Case Study On The FDA’s Regulation Of Off-Label Prescriptions

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Hoffman, Matthew A. en_US
dc.date.accessioned 2012-12-07T15:35:33Z
dc.date.issued 2003 en_US
dc.identifier.citation (2003 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:10015314
dc.description.abstract This paper is a case study in the legality and ethics of prescribing amphetamines (“go-pills”) to military aviators for fatigue management, a practice that has not been approved by the Food and Drug Administration (FDA). Currently, the FDA has very little authority to regulate this type of “off-label” prescription and would have to adopt its “Proposed Regulation on Prescribing for Uses Unapproved by the FDA” to have any chance of controlling the use of “go-pills” in the military. In the alternative, the agency could only regulate the drug indirectly through total withdrawal or limited distribution. However, many off-label prescriptions improve the practice of medicine and these alternative approaches would deny patients use of the drug for those indications that have been approved by the FDA. Therefore, this paper proposes an FDA “disapproval process” for those off-label prescriptions that are an imminent danger to public health. 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 Military en
dc.subject Amphetamines en
dc.subject Prescription en
dc.title The Military’s Need For “Speed”: A Case Study On The FDA’s Regulation Of Off-Label Prescriptions en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-12-07T15:35:33Z

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