Reagan, regulation, and the FDA: the US Food and Drug Administration's response to HIV/AIDS, 1980-90

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 Reagun 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. Le debut de l'epidemie du sida dans les annees 1980 imposa un stress enorme sur la Food and Drug Administration (FDA), agence qui regle un quart de l'economie domestique americaine et qui protege la provision des medicaments de la nation. L'epidemie du sida a deja fait couler beaucoup d'encre et cette bibliographie continue a augmenter. Toutefois, une etude soigneuse de ce sujet est d'une importance capitale pour comprendre l'interaction entre les agences regulatrices, l'organe executif du gouvernement, l'industrie et le public. Periodiquement, le FDA a traverse des phases qui etaient dominees par des priorites diverses. A un moment donne ou un autre, il a brille en tant qu'agence regulatrice, service charge de faire respecter la loi et organisme scientifique selon le parti politique au pouvoir, l'ideologie du directeur du FDA et l'influence des actionnaires externes. L'epidemie du sida qui provoqua une nouvelle et vigoureuse coalition d'activistes du sida, de reformateurs et de libertaires, mirent a l'epreuve l'identite institutionnelle de l'agence. Pour certains commentateurs, la gestion par le FDA de la crise du sida fut un gachis considerable analogue au fiasco de l'administration Reagan. Dans cette analyse, nous pretendons qu'en depit de l'absence de direction presidentielle, le FDA reussit a relever le defi de l'epidemie du sida dans les annees 1980 en refaconnant ses statuts existants, en approchant le mouvement sideen et l'industsrie pharmaceutique tout en maintenant son engagement serieux a proteger le public.
While there has been much effort to refocus the FDA toward patients the past eight years, there has been relative silence from one man: Ronald Reagan. Wall Street Journal, 13 [...]