COMMERCIAL DRUG CLAIMS, THE FDA, AND THE FIRST AMENDMENT

Abstract

In two strands of what can only be described as extremely protracted litigation, the courts have begun to articulate a framework by which to evaluate these competing claims. Although the doctrine is hardly settled, in two lines of cases, Washington Legal Foundation v. Friedman and Pearson v. Shalala, courts have shifted the doctrine from requiring a unilateral ban on non-FDA approved advertising to a regime in which manufacturers of drugs and dietary supplements have more freedom to publicize their products, so long as they are accompanied with appropriate disclaimers. I argue in this paper that while this more nuanced approach is surely an improvement over the FDA’s adamant refusal to acknowledge any First Amendment protection for these claims, it is still not entirely clear how much protection these claims should deserve in the face of public safety concerns. Because courts have not fully considered these countervailing concerns in granting First Amendment protections we must wait for a fully articulated and justifiable framework for weighing the speech interests in these cases against the interest of public safety.