Reconciling the Lanham Act and the FDCA: A Comment on Chris Hurley's Note

By Seaman, Christopher B. | Washington and Lee Law Review, Winter 2018 | Go to article overview

Reconciling the Lanham Act and the FDCA: A Comment on Chris Hurley's Note


Seaman, Christopher B., Washington and Lee Law Review


I.Introduction

In POM Wonderful LLC v. Coca-Cola,1 the U.S. Supreme Court unanimously2 held that a claim for false or misleading advertising under Section 43(a) of the Lanham Act3 was not preempted by the Federal Food, Drug, and Cosmetics Act4 (FDCA) simply because the allegedly false or misleading beverage label at issue-which prominently displayed the words "pomegranate blueberry" despite containing less than a thimbleful of either pomegranate juice or blueberry juice5-fell within the scope of the Food and Drug Administration's (FDA) regulatory authority under the FDCA.6 Rather, the Court concluded that the Lanham Act and the FDCA "complement each other in major respects" because "[a]though both statutes touch on food and beverage labeling," they serve different objectives, as "the Lanham Act protects commercial interest against unfair competition, while the FDCA protects public health and safety."7 Furthermore, it explained that the two statutes' remedial schemes are complementary as well, as the FDA possesses the technical knowledge needed to regulate the health and safety of various consumer products, but it lacks "the expertise in accessing market dynamics that day-to-day competitors possess."8 In contrast, the Lanham Act "draws upon this market expertise by empowering private parties to sue competitors" for market harm caused by false advertising.9

In particular, the Court's opinion distinguished between food and beverage labels and other products that are more heavily regulated by the FDA, noting that the FDA did not preapprove juice labels, in contrast with other types of labels, such as prescription drugs.10 This has led both commentators11 and courts12 to question whether POM Wonderful's holding is limited and does not extend to other products, such as pharmaceuticals and medical devices, which are more heavily regulated by the FDA and require preapproval. To date, however, there has been little discussion of an important related issue: whether a drug maker's promotion of a FDA-approved drug for a non-approved condition, which is commonly known as "off-label use," also can be subject to claims of false or misleading advertising or promotion under Section 43(a).13

Fortunately, we have Chris Hurley, who fills this important gap in the literature with his award-winning Note. In particular, Mr. Hurley's Note addresses the difficult question of reconciling the language of two complex statutes, as well as the competing public policy concerns at play: (1) ensuring the safety and efficacy of pharmaceutical drugs through evidence-based regulation, and (2) preserving the ability of physicians and patients to access information about potentially beneficial non-approved uses of such drugs. Ultimately, Mr. Hurley argues the Court's decision in POM Wonderful should extend to off-label advertising and promotion that is false or misleading, thus allowing claims against drug makers under Section 43(a) for such conduct.14 As described further below, while I agree with the Note's main thesis-I similarly would conclude that a Section 43(a) claim against false or misleading statements related to off-label promotion is not preempted by the FDCA-I also contend that courts should be cautious in determining what constituted "false or misleading . . . advertising or promotion" regarding off-label use, for fear of chilling the dissemination of valuable information about potentially efficacious but unapproved uses of FDA-authorized drugs.

The remainder of this Comment proceeds as follows. Part I addresses the issue of "off-label" promotion and explains why off-label use of drugs are both common and beneficial in the practice of modern medicine, but also can be problematic. Part II covers false and misleading advertising under Section 43(a) of the Lanham Act, including past cases where courts permitted claims involving the promotion of regulated pharmaceutical products to go forward despite the FDA's extensive regulatory process for approving for such products under the FDCA. …

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