Three Principles That Govern FDA Advertising and Promotion Regulation

Abstract

The Food and Drug Administration (FDA) has few formal regulations applicable to pharmaceutical promotion, and lately has taken few publicly-available enforcement actions. This makes it challenging for companies to comply with FDA policies. Over the years, however, the agency has followed a few basic principles that apply to advertising and promotion. These include FDA's view that it has jurisdiction over all marketing activities; that “off-label” promotions are prohibited; and that claims must be fairly balanced and represent full disclosure. FDA should do a better job of explaining its policies and actions, but in the meantime, regulated companies can understand how to comply by understanding these basic principles.