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

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

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