FDA Regulations And The Regulation Of Constitutionally Protected Speech

"Speech in aid of pharmaceutical marketing...is a form of expression protected by the Free Speech Clause of the First Amendment." Sorrell v. IMS Health, Inc., 131 S. Ct. 2653, 2659 (2011). That sentence, which appears prominently in the first paragraph of the Court's decision last term in Sorrell, doomed a Vermont law restricting the sale of pharmacy records of individual doctors. The principles which underlie that sentence sweep more broadly than that, however, to cast a First Amendment shadow over a range of governmental regulatory activities, including those of FDA. This shadow may well have important implications for product liability tort litigation.Various government regulations impact speech, sometimes compelling speech and sometimes prohibiting or restricting speech. Government compels speech when, for example, a statute or an agency rule requires warnings or disclosures on packages or other materials. Government limits or prohibits speech when, as in Sorrell, a statute restricts the sale of information or when a regulatory regime prohibits the off-label promotion of an approved drug.

Tobacco warnings and compelled speech

A current example of a regulation which compels speech is FDA's rule requiring cigarette companies to display graphic warnings on cigarette packages. In the Family Smoking and Prevention Act, Congress directed FDA to promulgate a rule mandating the display on cigarette packages of graphic images depicting the negative consequences of smoking. FDA did as it was told and developed a set of dramatic images. FDA then issued a rule mandating that these images, along with blunt textual warnings, occupy 50 percent of each cigarette package.

In response to FDA's rule, several tobacco companies filed suit, challenging the rule on First Amendment Free Speech as well as Administrative Procedure Act grounds. The United States District Court for the District of Columbia (Judge Leon) granted the companies' motion for a preliminary injunction. The court found that there was a substantial likelihood that the companies would prevail on their First Amendment claim. See R.J. Reynolds Tobacco Co. v. FDA, Civil Case No. 11-1482 (November 7, 2011). The government's appeal is pending.As we await the outcome of the appeal in R.J. Reynolds, it is worth noting that there is other relevant precedent invalidating a regulatory regime which compels speech. In Entertainment Software Ass'n v. Blagojevich, 469 F.3d 641 (7th Cir. 2006), for example, a case upon which the district court in R.J. Reynolds relied, the...