The FDA Does Not Approve Uses of Drugs

John D. Archer, MD
JAMA. 1984;252(8):1054-1055. doi:10.1001/jama.1984.03350080056029.
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As a reviewer of medical manuscripts and reader of published articles, I find it frustrating to continue to find reference to "Food and Drug Administration (FDA)—approved uses of drugs"—or worse, allegations that certain uses are "not approved." For nearly two decades, through published articles, speeches, and personal communications, I have cautioned the medical profession against such diction. Perhaps the most definitive article was "Instrument or Impediment? The Regulatory Monograph in Medical Communications."1 The FDA cannot approve or disapprove of how a legally marketed drug is used by a physician in his practice. The agency approves of what the manufacturer may recommend about uses in its labeling (package insert) and advertising.

Failure to recognize this distinction can have various harmful results. Many valid uses of drugs become recognized long before they are included in manufacturers' literature—provided they ever are. Such uses may range from the unstudied (but reasonable) to the


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