Off-Label Promotion, On-Target Sales 英文参考文献.docVIP

Policy Forum Off-Label Promotion, On-Target Sales Adriane Fugh-Berman*, Douglas Melnick F or prescription drugs, demonstrated benefits define the parameters of acceptable However, misoprostol is widely used off- label for ripening the cervix, inducing abortion, and other indications, and more than 200 studies involving more than 16,000 pregnant women support the use of misoprostol in obstetrics [2]. Pregnant women and children, however, do not account for most off-label use. In 2001, 150 million off- label prescriptions were written—21% of all prescriptions written for 160 common medications in the US. About three-quarters (73%) of off- label prescriptions were written for conditions for which there was little or no scientific support for efficacy [3]. Up to 75% of drug use in cancer care, and about 90% of drug use in rare diseases, is off-label [1]. that tested the efficacy of Vioxx (rofecoxib) for colon polyps turned up cardiovascular risks that eventually resulted in the drug being withdrawn [7]. The disadvantage of an off-label market is limited growth, because a company cannot legally promote sales. Warner-Lambert, a subsidiary of Pfizer, paid US$430 million in criminal fines and civil payments for off-label promotion of Neurontin (gabapentin) [8]. risks. For example, liver toxicity may be acceptable in a drug approved for cancer, but unacceptable in a drug approved for acne. Government regulatory bodies review laboratory, animal, and human data to confirm that a drug has the claimed efficacy and safety prior to approving its release in the market for specific approved (“labeled”) uses. Once a drug is approved for at least one indication, it may be prescribed off-label for a different condition, a different population, or in a different dose than what the drug is approved for. However, off-label uses have not been subject to the testing and review that is a precondition for marketing approval. The scientific review of evidence of effectiveness and safety that