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Drug use, the package insert, and the practice of medicine.

Increasing emphasis on the import of the package insert has been the focus of concern in clinical therapeutics as it alters drug-use decisions and, thus, the practice of medicine. A multidisciplinary group report from the American Society of Clinical Pharmacology and Therapeutics 1 (representing the Food and Drug Administration, legal counsel from the American Medical Association, and representative clinical therapists) addresses a structured posture to decide on drug selection or dosage, specifically when the circular is silent. This is a summary of that report and those recommendations. ROLE OF THE PACKAGE INSERT An assumption has arisen among physicians, patients, and, often, legislators and regulators that drugs are properly limited to so-called approved uses, as specified in the package circular. Yet such labeling recommendations follow medical practice and the literature rather than lead it. Thus, otherwise available therapy would be unconscionably delayed were strict adherence to this interpretation of a required