12 Angry Men v. The Agency: Why Preemption Should Resolve this Conflict in Drug Labeling Litigation
Posted: 23 Aug 2017
Date Written: August 21, 2016
The Supreme Court has found in favor of preemption in tort liability cases involving matters of heavy federal regulation in which Congress has delegated implementation of a statute involving technical subject matter to the agency. It has not been the case, however, in matters concerning the labeling of prescription drugs, despite the fact that the FDA has exclusively regulated drug labeling for more than a century. In fact, the current state of affairs now allows a jury to substitute the judgment of the FDA in approving a label on a name-brand drug for their own in state law failure to warn claims, allows for preemption on the same question when a generic drug manufacturer is involved, and a proposed rule by the FDA set to be released in April of 2017 could remove the protection of preemption for generic manufacturers, in contravention of the purpose and goals of the Hatch-Waxman Amendments to the FDCA. To support the delegation of power given to FDA to regulate drug labeling, prevent juries from second-guessing the propriety of an FDA-approved drug label, and encourage generic manufacturers to remain in the market and provide consumers access to drugs at a lower cost, Congress should provide for express preemption to both name-brand and generic manufacturers in failure to warn cases.
Keywords: preemption, drug labeling, Hatch-Waxman
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