Toward National Uniformity for FDA-Regulated Products

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Toward National Uniformity for FDA-Regulated Products

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Title: Toward National Uniformity for FDA-Regulated Products
Author: Semet, Amy E.
Citation: Toward National Uniformity for FDA-Regulated Products (2000 Third Year Paper)
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Abstract: In this paper, I will argue that national uniformity should be granted to all FDA-regulated products and should include preemption of both state labeling and safety standards as well as state product liability laws. Cosmetics and food should be treated the same as FDAMA treats OTC drugs. Although the FDA has developed different regulatory regimes for each product, the FDA has established the optimal standards for all of its products, and states should not interfere to preclude harmonization. Congress should also prevent state courts and lay juries from interfering with the goals of the FDA to both ensure the safety of products, while at the same time, encourage innovation. The Supreme Court has said, "state regulations can be as effectively exerted through an award of damages as through some form of preventive relief. The obligation to pay compensation can be, indeed is designed to be, a potent method of governing conduct and controlling policy." Congress needs to recognize that state tort claims impose requirements for safety and effectiveness that can be just as detrimental to the goals of national uniformity as state labeling and safety standards. The benefits of national uniformity for FDA-regulated products can never be fully realized if state tort suits interfere as an additional regulatory tool to monitor safety. FDAMA itself is inherently contradictory, because the explicit allowance of state tort suits conflicts with the Act's goal of national uniformity. Manufacturers are caught in a "physical impossibility," because even if manufacturers comply with nationally uniform FDA standards, the threat of tort liability results in an incentive to overwarn and to include information that departs from a uniform FDA standard.
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