Prescription Drugs:

Implications of Drug Labeling and Off-Label Use

T-HEHS-96-212: Published: Sep 12, 1996. Publicly Released: Sep 12, 1996.

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GAO discussed off-label drug use and its impact on drug promotion and advertising. GAO noted that: (1) off-label drug use is a prevalent phenomenon because the drug industry feels overly constrained by labels in its ability to promote pharmaceutical products; (2) physicians can use approved drugs for conditions or patients other than those listed on the drugs' labels, but manufacturers cannot advertise or promote such use; (3) the extent of off-label drug use has not been documented, but there is evidence that off-label use is common among cancer, acquired immunodeficiency syndrome, and pediatric populations; (4) in the past, off-label use caused reimbursement problems, but 1993 legislation has led insurers to rely on additional sources of information in making their reimbursement decisions; (5) Congress is considering legislation to allow manufacturers to base their advertising and promotion on reputable sources of drug use information in addition to drug labels; (6) the benefits of such an approach include avoiding the cost of supplemental drug approval applications and allowing earlier promotion, but some promising off-label drug uses have been ineffective or harmful to patients; (7) the Food and Drug Administration (FDA) could expedite its approval process by updating labels to list new drug uses; and (8) FDA has improved its timeliness in processing drug applications and efficacy supplements and has changed the evidence requirements for drug use approval under certain circumstances.

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