Information Requirements of Health Systems as Drug Purchasers: Does the FDA Have a Role in Setting Evidentiary Standards?

ABSTRACT: The objective of this article is to consider the information needs of drug purchasers; whether the Food and Drug Administration (FDA) should have a role in regulating information on the characteristics and cost-outcomes impact of new pharmaceutical products to health care purchasers; and the requirements in the new FDA Modernization Act of 1997 for "competent and reliable scientific evidence." Market-mediated advertising claims are compared to regulated market claims and the role of the market in potentially limiting the flow of deceptive information. The author concludes that the FDA should not attempt to micromanage information flow in promotion and marketing campaigns, but should consider the Federal Trade Commission approach to deceptive advertising with possible inputs in gray areas from an expert panel.