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42 Food Drug Cosm. L.J. 567 (1987)
The Odyssey of Depo-Provera: Contraceptives, Carcinogenic Drugs, and Risk-Management Analyses

handle is hein.journals/foodlj42 and id is 573 raw text is: FOOD DRUG COSMETIC LAW JOURNAL 42, 567-587 (1987) The Odyssey of Depo-Provera: Contraceptives, Carcinogenic Drugs, and Risk-Management Analyses WILLIAM GREEN, J.D., PH.D.* INTRODUCTION Depo-Provera has been a scientific and political battleground for over twenty years. At stake have been the reproductive health of women, the marketing of a long-acting contraceptive by a multinational corporation, and international family planning and population control. Seventy nations have approved its use as a fe- male contraceptive, but the U.S. Food and Drug Administration (FDA) has not, because the drug is a suspected carcinogen. FDA's decision means marketing of Depo-Provera as a contraceptive is forbidden in the United States and in U.S. foreign aid programs. FDA's decision also means the drug is less likely to be used in Third World family planning programs. Depo-Provera's administrative odyssey provides an opportunity to examine government regulation of the contemporary pharmaceutical revolution in contra- ception and FDA's technology transfer function, i.e., determining whether a con- traceptive drug is safe and effective for general use. Depo-Provera's odyssey also provides the opportunity to examine three questions about the risk-management process the Agency uses to perform its technological transfer function. Why did FDA have to rely on ambiguous and uncertain scientific research about a drug's carcinogenic risk? How did FDA weave together uncertain scientific facts with political and social values to make drug risk-management decisions? How politi- cally and scientifically accountable was FDA in making its carcinogenic risk-man- agement decisions about a contraceptive drug? In sum, Depo-Provera's odyssey provides the opportunity to further our understanding of the politics of regulatory science. The conventional view of the risk-management process provides a beginning point for answering these questions. The risk-management process, according to this view, is based on a two-stage model.' Risk assessment, the first stage, is the * Dr. Green is Associate Professor of Government, Morehead State University, and Research Associate, Institute for Mining and Minerals Research, University of Kentucky. B.A., cum laude, Kent State University, 1963; M.A., Kent State University, 1967; Ph.D., State University of New York at Buffalo, 1977; and J.D., University of Kentucky, 1984. The author presented an earlier draft of this article at the American Political Science Ass'n 1986 Annual Meeting under the title Politics of Phar- maceutical Innovation and Regulation: The Food and Drug Administration and the Odyssey of Depo- Provera. This article benefited from the comments of Professor Mark Rushefsky, Southwest Mis- souri State University and Professor John Batt, College of Law, University of Kentucky. I NATIONAL ACADEMY OF SCIENCES, RISK ASSESSMENT IN THE FEDERAL GOVERNMENT: MAN- AGING THE PROCESS 3 (1983). 567 0015-6361/87 $3.00 Copyright © 1987 by Academic Press, Inc. All rights of reproduction in any form reserved.

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