Off-label prescribing and marketing of prescription drugs has come under fire recently, but the extent of off-label use of high-utilization drugs illustrates some of the shortcomings of clinical trials for pharmaceutical products. In this paper published in Pharmaceutical Commerce, Jill Van Den Bos and Daniel Perlman look for evidence of how often high-cost drugs are prescribed for off-label uses. They conclude that apparent off-label use should be examined carefully, as the analysis may give pharmaceutical companies important clues as to whether it may be worthwhile to seek FDA approval for a currently non-approved indication for use of a drug.

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