Healthy Skepticism Library item: 604

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Neumann PJ, Zinner DE, Paltiel AD.
The FDA and regulation of cost-effectiveness claims.
Health Aff (Millwood) 1996 Fal; 15:(3):54-71

Abstract:

The Food and Drug Administration (FDA) has issued draft guidelines that would require more rigorous standards for making pharmacoeconomic claims. This paper critiques the guidelines and explores the objectives of market regulation for health-related cost and effectiveness information on pharmaceutical products. It argues that the FDA should proceed with caution and flexibility. In particular, regulations should recognize the potential usefulness of pharmacoeconomic information in helping 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 various players in the market can impose their own regulatory discipline.

Keywords:
*analysis United States regulation of promotion Food and Drug Administration FDA pharmacoeconomic analysis INFORMATION FROM INDUSTRY: PHARMACOECONOMIC ANALYSIS REGULATION, CODES, GUIDELINES: COMPLIANCE, SANCTIONS, STANDARDS REGULATION, CODES, GUIDELINES: DIRECT GOVERNMENT REGULATION