Ideals and Issues From a Critical View of the Supreme Court’s Jurisprudence in FDA Regulation of Human Drugs

Abstract

Since Congress first enacted an extensive regulatory regime for human drugs in 1906 with the Pure Food and Drug Act, the Supreme Court has shaped the contours of federal drug regulation with a variety of legal doctrines and policy prescriptions, particularly with regard to the regulatory authority of the federal Food and Drug Administration (FDA). At the same time, the Court has constructed and reinforced key ideals of drug regulation that both inform the authority of the FDA and foreclose or mitigate other ideals that are crucial to understanding the public interest in drug regulation. This essay provides a broad overview of the Court’s jurisprudence in the area of federal drug regulation, first by briefly summarizing the statutory history and the Court’s decisions. The essay then gleans three major ideals from these decisions: prophylactic public health purposes, agency self-legitimation, and democratic process. Finally, the essay criticizes the Court’s jurisprudential moves, particularly that of underestimating the democratic process ideal. In addition, it provides preliminary conclusions on how the Court and the government overall, through a promotion of greater public participation in the regulatory process, stronger recognition of “public rights,†and a more cooperative vision of government-industry relations, can better effect elements of democratic process in an area of regulation that is intimately connected to everyday life.