The Off-Label Use of POM Wonderful: Using Section 43(a) to Eliminate Misleading Off-Label Drug Promotion †

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

The Off-Label Use of POM Wonderful: Using Section 43(a) to Eliminate Misleading Off-Label Drug Promotion †


Hurley, Christopher A., Washington and Lee Law Review


Table of Contents

I. Introduction.594

II.A Comparison of the FDCA and the Lanham Act, and Their Application in POM Wonderful.598

A. FDCA.599

B. Lanham Act Section 43(a).603

C. A Comparison of the Lanham Act and the FDCA in POM Wonderful . 606

III. The Rise of Off-Label Medication Use and Issues Inhibiting Regulation.610

A. Pharmaceutical Companies Challenge FDA Regulations as Violating the First Amendment.613

B. POM Wonderful's Application to Drug-Related Claims.619

IV. FDA Regulations Preclude Lanham Act Claims Challenging Off-Label Promotion.624

A. Direct Conflict with FDA Policy Decisions.625

B. Usurpation of FDA Authority.629

V. A Return to POM Wonderful: Allowing Enforcement Through Section 43(a).632

A. Off-Label Promotion is Unfair Competition.633

B. Section 43(a) Claims Will Protect the FDA's Stated Interests.637

1. Maintaining Validity of the NDA Process.638

2. Balancing Necessary Treatments with a Potential for Dangerous Side Effects.640

a. Section 43(a) Does Not Limit Access to Necessary Treatments.641

b. Section 43(a) Will Help Eliminate Dangerous Off-Label Treatments.643

VI. Conclusion.645

I. Introduction

On his way home from the hospital with his newborn son, a hit-and-run accident left Jeremy Lew with a severely injured spine.1 Lew underwent surgery, during which his doctor implanted a device approved by the Food and Drug Administration (FDA) between his cervical vertebrae.2 The treatment initially appeared successful, but Lew later began suffering from "unrelenting" pain, barely able to pick up his children.3 Although the FDA approved the device, the agency intended it for use only in the mid-to-lower spinal column.4 The off-label use of the medical device caused Lew unimaginable pain as a result of his nerve injury, and could have further caused sterility, infection, or urinary problems.5 Nonetheless, the practice of using medications and medical devices for unapproved treatments continues.6

Advocates of off-label medication use tout highly successful treatments that have saved lives even when approved treatments have failed.7 For example, after doctors diagnosed Lisa Rosendahl with a glioblastoma-a highly lethal brain tumor-they estimated that she would live for only another twelve months.8 Rosendahl's doctor suggested she try chloroquine, a drug indicated for treating malaria and never before used for this type of illness, on the theory that the drug would make the tumor more vulnerable to existing treatments.9 Ultimately, chloroquine-in conjunction with the continued use of existing treatments-stabilized the tumor, and this use of the drug has since seen similar results in two other patients.10 This type of last-ditch effort understandably occurs in the treatment of otherwise fatal conditions, but off-label medication use commonly helps patients with less threatening illnesses as well.11

Typically, the FDA weighs a medication's benefits against potentially harmful side effects as part of its New Drug Application (NDA) process, established by the Food, Drug, and Cosmetic Act (FDCA).12 Reserving enforcement of off-label medication promotion to the expertise of the FDA, however, has proved somewhat unsuccessful.13 Because FDA enforcement creates a chilling effect on manufacturers' advertising, pharmaceutical companies have successfully challenged agency enforcement actions as violations of their First Amendment rights.14 After facing several challenges to its regulations, the FDA reduced the severity of its sanctions in an effort to avoid future lawsuits, but recent lower-court decisions have reinforced the notion that the FDA lacks a sufficient governmental interest to regulate this form of commercial speech.15

As an alternative, Section 43(a) of the Lanham Act16 allows private companies to sue their competitors for false or misleading advertising.17 The Supreme Court's recent decision in POM Wonderful LLC v. …

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