The Food and Drug Administration's Evolving Regulation of Press Releases: Limits and Challenges

Abstract

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.

Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. The agency has had to adjust its approach to account for First Amendment concerns and resource limitations, which has led FDA to cooperate with the Securities and Exchange Commission (SEC), and take more creative responses to allegedly violative press materials.

This article discusses how FDA has regulated press materials in the past, and how recent developments may signal new directions in the agency's regulatory approach. The article proposes a framework for evaluating whether FDA might assert jurisdiction, and what the rules are if it does. The article considers the legal theories behind FDA's approach and the implications for manufacturers.

Keywords: FDA, press release, media statement, First Amendment, commercial speech, pharmaceutical, device, regulation, health, administrative, agency