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

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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