THE FDA AND REGULATION OF COST-EFFECTIVENESS CLAIMS

The Food and Drug Administration (FDA) has issued draft guidelines tha t would require more rigorous standards for making pharmacoeconomic cl aims. This paper critiques the guidelines and explores the objectives of market regulation for health-related cost and effectiveness informa tion on pharmaceutical products. It argues that the FDA should proceed with caution and flexibility. In particular, regulations should recog nize the potential usefulness of pharmacoeconomic information in helpi ng health care decisionmakers make better-informed choices. They also should acknowledge the enhanced ability of those using the information to evaluate pharmacoeconomic studies and the degree to which the vari ous players in the market can impose their own regulatory discipline.