Everybody takes prescription drugs at some point in his life, and everybody knows about the fine print and packet inserts accompanying the prescription drugs. But who decides what the fine print actually says? Although the common response likely would be either the federal government or the drug manufacturer, prior to 2006, that response would be only partially correct.
Through the Federal Food, Drug, and Cosmetic Act (“FDCA”), Congress delegated responsibility to the Food and Drug Administration (“FDA”) for ensuring that all human drugs are safe and effective. The centerpiece of the FDA’s regulatory scheme giving effect to this statute is its control over prescription drug labeling, which the FDA, in conjunction with the drug manufacturers, closely and continuously scrutinizes. Despite the comprehensive federal regulation of the prescription drug field, prior to 2006, the near universal rule regarding drug labeling was that drug manufacturers in compliance with federal labeling standards could still be held liable for failure to warn under state law. This rule effectively allowed judges and juries, rather than the FDA, the ultimate decision-making power regarding the content of drug labeling. In concluding that compliance with federal regulations did not shield drug manufacturers from liability, courts rejected the notion that FDA drug labeling regulations preempt state tort failure-to-warn claims made against drug manufacturers. Set against this backdrop, the FDA, in a 2006 preamble to its final rule on prescription drug labeling, indisputably declared its intent for its regulations to preempt contrary or conflicting state law regarding prescription drug labeling. This assertion by the FDA is especially significant given the long-standing tradition of deference accorded to administrative agencies charged with implementing a statutory scheme.
This Comment explores the effect of the FDA’s Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products (“FDA Preemption Preamble”) on federal preemption jurisprudence in the pharmaceutical field, specifically with regard to prescription drug labeling. Since the issuance of the FDA Preemption Preamble, two courts have ruled in favor of federal preemption of state tort failure-to-warn claims, basing their decisions in part on the FDA’s Preemption Preamble. This Comment examines the analytical approaches taken by courts prior to the FDA Preemption Preamble and contrasts those approaches with the approaches taken following release of the FDA Preemption Preamble. Because the two approaches to the federal preemption issue differ significantly, this Comment addresses which approach is better given the clear statement by the FDA and the tradition of deference afforded to administrative agencies. Furthermore, this Comment explores additional reasons supporting federal preemption in the prescription drug arena, most notably the FDA’s expertise and experience in making determinations regarding safety and effectiveness of drugs and the need for a uniform national policy on drug labeling.
Part II.A of this Comment discusses the doctrine of federal preemption, including the types of preemption and the situations in which the doctrine is invoked. Part II.B provides background information pertaining to the FDA and the FDCA. Parts II.C-D discuss the status of federal preemption in the pharmaceutical field prior to the FDA’s 2006 Preemption Preamble, while Part II.E examines the content of the FDA Preemption Preamble itself. Next, Part II.F looks at the impact of the FDA Preemption Preamble on federal preemption jurisprudence in the pharmaceutical field. Finally, Part II.G contrasts the analytical approaches taken by courts prior to the FDA Preemption Preamble with those taken after the issuance of the FDA Preemption Preamble.
Part III.A of this Comment evaluates the manner in which the FDA’s 2006 Preemption Preamble fundamentally alters the approach courts take when addressing the issue of federal preemption in the pharmaceutical field. Part III.B discusses two very strong policy reasons–the expertise of the FDA and the need for national uniformity–supporting federal preemption in the pharmaceutical field, especially with regard to drug warning labels. Ultimately, this Comment argues the FDA has affirmatively asserted its intent to preempt state tort law in the pharmaceutical field. Therefore, the courts, in accord with the long-standing tradition of deference to administrative agencies charged with statutory regulation, should find federal preemption where state tort failure-to-warn claims conflict with determinations previously made by the FDA regarding prescription drug labeling.