
Contents
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1974 Limited Marketing Disapproval 1974 Limited Marketing Disapproval
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The OB/GYN Advisory Committee Recommendation The OB/GYN Advisory Committee Recommendation
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The FDA’s Limited Marketing Proposal The FDA’s Limited Marketing Proposal
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Congressional Scrutiny Congressional Scrutiny
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The FDA’s Revised Limited Marketing Proposal The FDA’s Revised Limited Marketing Proposal
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Congressional Intervention and FDA Retreat Congressional Intervention and FDA Retreat
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1978 General Marketing Disapproval 1978 General Marketing Disapproval
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OB/GYN and BEM Advisory Committee Hearing OB/GYN and BEM Advisory Committee Hearing
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The FDA’s Disapproval Decision The FDA’s Disapproval Decision
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Risk Assessment Criteria Risk Assessment Criteria
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Risk Management Judgment Risk Management Judgment
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Congressional Scrutiny Congressional Scrutiny
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Depo-Provera Public Board of Inquiry Depo-Provera Public Board of Inquiry
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The Interim Years The Interim Years
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Pre-Hearing Activities Pre-Hearing Activities
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The Board of Inquiry Hearing The Board of Inquiry Hearing
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The Board of Inquiry Report The Board of Inquiry Report
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Risk Assessment Analysis Risk Assessment Analysis
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Risk Acceptability Judgments Risk Acceptability Judgments
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Risk Management Recommendation Risk Management Recommendation
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1986 General Marketing Disapproval 1986 General Marketing Disapproval
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Summary Summary
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2 The Twenty-Five-Year FDA Approval Controversy: Cancer and the Politics of Acceptable Risk
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Published:May 2017
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Abstract
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.
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