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Contraceptive RiskThe FDA, Depo-Provera, and the Politics of Experimental Medicine$
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William Green

Print publication date: 2017

Print ISBN-13: 9781479876990

Published to NYU Press Scholarship Online: January 2018

DOI: 10.18574/nyu/9781479876990.001.0001

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PRINTED FROM NYU Press SCHOLARSHIP ONLINE (www.nyu.universitypressscholarship.com). (c) Copyright University of NYU Press Press, 2019. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in NYSO for personal use.date: 23 October 2019

The Twenty-Five-Year FDA Approval Controversy

The Twenty-Five-Year FDA Approval Controversy

Cancer and the Politics of Acceptable Risk

Chapter:
(p.45) 2 The Twenty-Five-Year FDA Approval Controversy
Source:
Contraceptive Risk
Author(s):

William Green

Publisher:
NYU Press
DOI:10.18574/nyu/9781479876990.003.0003

Judith Weisz's story of the politics of drug risk management shifts its focus to Depo-Provera's lengthy FDA marketing approval process. Here her story explores the scientific and political controversy over the FDA's assessment of the drug's risk and its policy judgments about the risk acceptability of its marketing approval. The controversy was dominated by the fear that the drug could cause breast, endometrial, and cervical cancer, and by Depo-Provera's uniqueness as a long-acting contraceptive and its use in international population control programs. The controversy began when the FDA relied on its Obstetrics and Gynecology Advisory Committee to grant the drug limited marketing approval in 1974, which it withdrew after congressional criticism, and then, following an intra-agency review, disapproved the drug for general contraceptive marketing which, once again, brought congressional scrutiny because of its impact on international family planning programs. An FDA Public Board of Inquiry, convened at Upjohn's request and chaired by Judith Weisz, conducted an intensive scientific assessment of the drug's animal and human studies at its 1983 hearings and then made a recommendation, accepted by the FDA in 1986, to disapprove the drug for general contraceptive marketing.

Keywords:   cancer, marketing approval, population control, risk assessment, risk acceptability

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