FDA/Freedom of Speech ­ What Can We Expect?

© Copyright 2003 by Emalee Murphy, J.D., Kirkpatrick & Lockhart LLP, Washington, DC; USA
(Explore Issue: Volume 12, Number 2)

FDA takes its responsibility for public health and safety very seriously. As it stated in a 2002 Federal Register Notice “The manner and substantive content of FDA’s regulation of speech has important implications for public health. False or misleading claims concerning foods, drugs, biologics, medical devices, cosmetics, or veterinary medicines may harm individuals who rely on those claims. Truthful claims, by contrast, may improve public health.” As the recognized arbiter of truthful statements about regulated products, FDA for many years has been supported in the courts. However, recently, FDA has encountered opposition to what appears to many as FDA’s chilling effect on freedom of speech. In fact, in the wake of several judicial defeats, FDA has called for comments on whether FDA has overstepped prohibitions set forth in the First Amendment that “Congress shall make no law … abridging the freedom of speech.” FDA has asked the public whether means other than its normal regulatory responses might not better protect the public health without violating the First Amendment.

Product labeling and advertising is considered to be “commercial speech”, for which the First Amendment protections are somewhat less than for other forms of expression. Nevertheless, in two recent cases, federal courts determined that FDA’s speech restrictions were too strict and that other means could have achieved the same public health goals. In Thompson v. Western States Medical Center, 122 S.Ct. 1497, U.S. (2002), the Supreme Court held that FDA’s restrictions on advertising by pharmacists related to their compounding drug services violated the First Amendment. In a second recent court decision in Washington Legal Foundation v. Friedman, 13 F. Supp 2d 51 (1998), and its appeal, Washington Legal Foundation v. Henney, 56 F. Supp. 2d 81 (1999), the District Court found that FDA infringed on First Amendment rights in prohibiting drug manufacturers from distributing to doctors independent journal articles that described so-called “off label” uses (non-FDA approved uses) for their drugs. In response to FDA’s claim that it restricted dissemination of the information so that physicians would not be mislead, the court stated that, “… in the commercial speech arena, …a State’s paternalistic assumption that the public will use truthful, nonmisleading commercial information unwisely cannot justify a decision to suppress it.” 44 Liquormart, 517517, U.S., at 497… To endeavor to support a restriction upon speech for his or her own protection, which is the gravamen of FDA’s claim here, is practically an engraved invitation to have the restriction struck.”