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The FDA and Drug Uses: Reprise

Stuart L. Nightingale, MD
JAMA. 1985;253(5):632. doi:10.1001/jama.1985.03350290034007.
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To the Editor.—  The recent editorial by Dr Archer1 is a useful addition to the literature exploring the nature and significance of official Food and Drug Administration (FDA) drug labeling and the role of such information in drug selection and use by physicians. The editorial correctly notes that the FDA cannot approve or disapprove of how a physician uses lawfully marketed drugs. The FDA can and does, however, approve indications for a drug's use and approves what a drug manufacturer may say in labeling, advertising, or publications intended to acquaint physicians with a drug's properties and uses. Although FDA officials2,3 have over the years sought to clarify the status and role of approved drug labeling, we felt that a wider audience needed to have an authoritative policy statement on this issue. We chose the FDA Drug Bulletin,4 as Archer notes, as the most appropriate vehicle since it


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