Dual regulatory pharmaceutical labeling schemes; the role of the Federal Preemption Doctrine

The Federal Drug Administration (FDA) has developed comprehensive procedural and substantive regulations to control the format of and information contained within package inserts distributed by pharmaceuticals. FDA regulations should be pervasive and preempt any state action on pharmaceutical labeling. However, courts have recently allowed jurors to reevaluate specific FDA scientific judgements in the context of product liability actions. This article discusses the Federal Preemption Doctrine as it relates to the regulation of package insert labeling by both the FDA and the state. First, the examination begins with background information on the Preemption Doctrine and the statutory authority of the FDA, followed by a discussion with a review of case law on the subject.