Abstract
This paper discusses the Food and Drug Administration's (FDA) initial attempts to develop a policy and standards on cost-effectiveness claims. The agency has had difficulty accomplishing this because much of the information produced by safety and efficacy trials is not the information needed by health plans, practitioners, and patients. Political change in Washington this past year has raised new questions about just what FDA's role should be in regulating economic information. FDA needs to conduct a major rethinking of its review process, keeping in mind the kind of information everyone involved in the health care delivery system needs.
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