WHEN IS A COST-EFFECTIVENESS CLAIM VALID - HOW MUCH SHOULD THE FDA CARE

Federal law requires the Food and Drug Administration (FDA) to regulat e the promotional claims of prescription drugs and certain devices. St andards of evidence for claims of safety and therapeutic efficacy are rigorous because inappropriate product use may place human life at ris k. However, equally demanding criteria for claims of cost effectivenes s of marketed technologies seem to be unnecessary because the conseque nce of error is principally a bad buy rather than patient harm. Concer n exists about the validity of cost-effectiveness studies, the potenti al for bias, standards for the conduct of cost-effectiveness research, and the needs of managed care. The FDA should moderate its role in re gulating cost-effectiveness. claims of drugs and devices. This would f oster information flow to healthcare providers and insurers and protec t the FDA concern regarding false or misleading claims of effectivenes s. Although the issues are applicable to both devices and drugs, we dr aw mainly from the field of pharmacoeconomics because this is where mo st of the policy has developed.