Drug Promotion for an Unlabeled Indication -- The Case of Topical Tretinoin

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Abstract
In 1972, topical tretinoin (Retin-A, Ortho Pharmaceutical) was approved for the treatment of acne. Today this remains the only medical indication for its use approved by the Food and Drug Administration (FDA). In 1988 a highly publicized study reported that topical tretinoin improves the appearance of “photoaged” skin1. Since then, the manufacturer of topical tretinoin has conducted an active, controversial multimedia effort to ensure that the general public and the medical profession are aware of the “unlabeled” use of tretinoin to treat benign cutaneous changes, such as wrinkles and brown spots, that may be annoying to patients because of their association with the appearance of aging. The commissioner of the FDA, members of Congress, and others have cited these efforts as an example of inappropriate promotion of a drug for an unlabeled use2-5. The greatly increased attention to topical tretinoin in the medical and lay press and the substantial increase in the number of prescriptions written for this agent since 1988 suggest that the company's actions in promoting the unlabeled use were successful and highly profitable.

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