PHYSICIAN PRESCRIBING PRACTICES AND ADVERSE DRUG REACTIONS: A Proposal for Further FDA Regulation of Prescription Drugs

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PHYSICIAN PRESCRIBING PRACTICES AND ADVERSE DRUG REACTIONS: A Proposal for Further FDA Regulation of Prescription Drugs

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Corrigan, Kerry A. en_US
dc.date.accessioned 2012-07-06T21:59:54Z
dc.date.issued 1995 en_US
dc.identifier.citation PHYSICIAN PRESCRIBING PRACTICES AND ADVERSE DRUG REACTIONS: A Proposal for Further FDA Regulation of Prescription Drugs (1995 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8965602
dc.description.abstract In 1938 the Food and Drug Administration (FDA) adopted regulations which created a category of prescription drugs to be distributed only by order of a physician or other licensed medical personnel. This categorization, along with the extensive regulation of the approval, labelling and marketing of human drugs, has substantially reduced the risks which accompanied self-medication. However, the current regulatory regime does not place any limits on physician prescribing. This shortfall in regulation fails to protect patients from poor prescribing practices and exposes these patients to otherwise preventable adverse drug reactions (ADRs). Attempts to remedy this shortfall have been unsuccessful. Under the existing Food, Drug and Cosmetic Act (FD&C Act) and its judicial interpretation in An~rican Pharmaceutical Ass 'n v. Weinberge , the FDA seemingly does not have the authority to regulate physician prescribing practices. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject physician prescribing practices en
dc.subject off-label en
dc.title PHYSICIAN PRESCRIBING PRACTICES AND ADVERSE DRUG REACTIONS: A Proposal for Further FDA Regulation of Prescription Drugs en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-07-06T21:59:54Z

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