Luce B R, Hillman A L
MEDTAP International, Inc., Bethesda, MD 20814, USA.
Am J Manag Care. 1997 Nov;3(11):1660-6.
Federal law requires the Food and Drug Administration (FDA) to regulate the promotional claims of prescription drugs and certain devices. Standards of evidence for claims of safety and therapeutic efficacy are rigorous because inappropriate product use may place human life at risk. However, equally demanding criteria for claims of cost-effectiveness of marketed technologies seem to be unnecessary because the consequence of error is principally a bad buy rather than patient harm. Concern exists about the validity of cost-effectiveness studies, the potential for bias, standards for the conduct of cost-effectiveness research, and the needs of managed care. The FDA should moderate its role in regulating cost-effectiveness claims of drugs and devices. This would foster information flow to healthcare providers and insurers and protect the FDA concern regarding false or misleading claims of effectiveness. Although the issues are applicable to both devices and drugs, we draw mainly from the field of pharmacoeconomics because this is where most of the policy has developed.
联邦法律要求食品药品监督管理局（FDA）对处方药和某些器械的促销声明进行监管。由于不当使用产品可能危及生命，因此对安全性和治疗效果声明的证据标准要求严格。然而，对于已上市技术的成本效益声明，似乎没有必要采用同样严格的标准，因为错误的后果主要是购买不当，而非对患者造成伤害。人们对成本效益研究的有效性、偏差可能性、成本效益研究的开展标准以及管理式医疗的需求存在担忧。FDA应适度调整其在监管药品和器械成本效益声明方面的作用。这将促进信息流向医疗服务提供者和保险公司，并保护FDA对有效性虚假或误导性声明的关注。尽管这些问题对器械和药品都适用，但我们主要借鉴药物经济学领域的内容，因为这是大部分政策发展的领域。
