In a 2006 preamble to a regulation, for the first time the FDA expressed the opinion that state- aw actions “threaten FDA’s statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs.” What might have motivated this dramatic change in the agency’s traditional position?
Today, more than eleven thousand drugs are available in the U.S. health-care market. The federal Food and Drug Administration (FDA) has the administrative power to monitor and regulate these drugs and their sales, but it has limited resources with which to exercise this authority. Before Congress enacted the first significant federal public health law—the Federal Food and Drugs Act—in 1906, consumers injured by unsafe and ineffective drugs or their inadequate warnings could bring claims under state law. Aware of this situation, Congress did not attempt to change it.
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