Marketing Pharmaceutical Products in the Twenty-First Century: An Analysis of the Continued Viability of Traditional Principles of Law in the Age of Direct-to-Consumer Advertising
Schwartz, Victor E., Silverman, Cary, Hulka, Michael J., Appel, Christopher E., Harvard Journal of Law & Public Policy
INTRODUCTION I. MARKETING AND REGULATION OF PHARMACEUTICALS FROM PAST TO PRESENT A. Concepts of Product Mislabeling and Pre-Market Regulation B. Establishment of the Modern Regulatory Regime for Approval and Marketing of Prescription Drugs C. DTC Advertising and Its Regulation Today D. The Relevance of History to DTC Advertising Today II. THE POTENTIAL BENEFITS AND PITFALLS OF DTC ADVERTISING III. TRADITIONAL RULES OF LAW REMAIN VIABLE, SOUND PUBLIC POLICY TODAY A. Ask Your Doctor: The Learned Intermediary Doctrine 1. Learned Intermediary Fundamentals 2. Traditional Limited Exceptions to the Rule 3. A Few Recent Decisions Chip Away at the Learned Intermediary Rule 4. Exceptions for DTC Marketing Represent Unsound Policy B. Effect of Compliance with FDA Requirements on Liability 1. Common Law Principles 2. Statutory Consideration of the Effect of Regulatory Compliance on Liability a. Presumption of Nondefectiveness b. Preclusion of Punitive Damages for FDA-Approved Pharmaceuticals c. Placing Regulated Conduct Beyond the Scope of Consumer Protection Laws C. Conflicts with Federal Authority: Preemption 1. Methods of Preemption 2. The FDA's Changing Priorities in a DTC Environment 3. Public Policy Supports Expanding Scope of Preemption CONCLUSION
According to a recent article in the New England Journal of Medicine, total pharmaceutical industry spending on direct-to-consumer (DTC) advertising of prescription drugs rose from $985 million in 1996 to $4.2 billion in 2005--an increase of 330%. (1) As a result, advertisements for prescription drugs are pervasive and consumers regularly view them in magazines and online, watch them on television, and listen to them on the radio.
This figure, however, must be put in perspective. Research also shows that during the same period, spending on pharmaceutical marketing increased not only for DTC advertising, but also across the board, from about $11.4 billion to $29.9 billion. (2) In fact, although DTC advertising has increased steadily both in absolute terms and as a percentage of pharmaceutical sales, promotion of drug treatments directly to physicians and other health care professionals still far outweighs DTC advertising. (3) In 2005, $7.2 billion was spent on promotion to physicians alone. (4) Relatively speaking, DTC advertising is concentrated on a small number of brands. (5) Its reach, however, is considerable, and DTC advertising is the subject of significant debate among courts and commentators. (6)
In light of these changes in the marketing environment, this Article examines whether traditional legal principles governing the duty to warn of the risks of pharmaceutical products remain sound public policy. First, the Article considers the early history of the sale and marketing of pharmaceutical products, discussing the initial tragic absence of regulation, followed by the establishment of the FDA and the pre-market approval process. It then examines the modern age of pharmaceutical advertising, including the FDA's relatively recent guidance on DTC broadcast advertising and the extent of its regulation. Finally, the Article examines rules of law that establish the legal landscape for warnings and advertising in the pharmaceutical context. This includes the learned intermediary doctrine, the effect of regulatory compliance on product liability and consumer protection claims, and the application of conflict preemption principles to tort law claims involving FDA-approved products.
The Article finds that the two foundational tenets underlying these doctrines have not changed. …