FDA Preemption After the Food and Drug Amendments Act of 2007

Abstract

Opposing the explosive rise in tort litigation in the last two decades has been a corresponding rise in federal preemption claims. In the FDA context, the controversy has largely surrounded the issue of whether federal law preempts state common-law “failure-to-warn” claims against drug and medical-device manufacturers. During the current Bush Administration, FDA changed its position regarding preemption of state tort law claims and for the first time asserted that that compliance with FDA-mandated labeling provisions preempts common law failure-to-warn claims. The changed position attracted considerable attention in the academic and legal community, and the preemption debate has consequently become one of fiercest battles in products liability litigation today. Indeed, the Supreme Court is scheduled to hear a case next Term addressing preemption of products liability claims against drug manufacturers. Any decision addressing preemption of drug-based products liability claims will have to consider the impact of the recent Food and Drug Amendments Administration Amendments Act of 2007 (“FDAAA”). This Act significantly expands FDA’s enforcement and surveillance powers, provides a framework for post-market risk identification, and expands the requirements for clinical trials registration and disclosure of results, among other provisions. This Paper therefore examines the impact of the FDAAA on FDA’s preemption claims and concludes that by strengthening FDA’s powers, the FDAAA may also have strengthened FDA’s claim for preemption. By increasing the FDA’s ability to effectively regulate drug efficacy and safety, the FDAAA put the agency on stronger ground when claiming ultimate authority over drug labeling.