Reagan, Regulation, and the FDA: The US Food and Drug Administration's Response to HIV/AIDS, 1980-90

Abstract

The beginning of the AIDS epidemic in the 1980s placed tremendous strain on the Food and Drug Administration, regulator of one quarter of the domestic US economy and protector of the nation's drug supply. Much has already been written on the AIDS epidemic, and this body of literature continues to expand, but careful consideration of this subject matter is of crucial significance to understanding the interaction between regulatory agencies, the executive branch, industry, and the public. Periodically, the FDA has gone through phases in which various priorities dominated. At one point or another it has distinguished itself as a regulatory agency, law enforcement agency, and science agency, depending on the political party in power, the ideology of the FDA Commissioner, and the influence of external stakeholders. The AIDS epidemic, which gave rise to a new and robust coalition of AIDS activists, reformers, and libertarians, tested the agency's institutional identity. To some commentators, the FDA’s management of the AIDS crisis was a serious blunder, akin to the Reagan administration’s failure. This paper contends, however, that despite the absence of presidential leadership, the FDA succeeded in rising to the challenge of the AIDS epidemic in the 1980s by refashioning its existing regulatory rules, reaching out to the AIDS movement and the pharmaceutical industry, and maintaining its strong commitment to consumer protection.

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