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New Rules on Prescription Drug Preemption–State Law Actions and FDA's Statutorily Prescribed Role

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State law actions also threaten FDA’s statutorily prescribed role as the expert federal agency responsible for evaluating and regulating drugs. State actions are not characterized by centralized expert evaluation of drug regulatory issues. Instead, they encourage, and in fact require, lay judges and juries to second-guess the assessment of benefits versus risks of a specific drug to the general public, the central role of FDA, sometimes on behalf of a single individual or a group of individuals. That individualized reevaluation of the benefits and risks of a product can result in relief, including the threat of significant damage awards or penalties, that creates pressure on manufacturers to attempt to ad warnings that FDA has neither approved nor found to be scientifically required. This could encourage manufacturers to propose “defensive labeling” to avoid State liability, which, if implemented, could result in scientifically unsubstantiated warnings and underutilization of beneficial treatments.

Tomorrow: FDA Conclusions on Preemption