Contraceptive Risk: The FDA, Depo-Provera, and the Politics of Experimental Medicine
William Green
Abstract
The odyssey of Depo-Provera is a study of the politics of contraceptive drug risk management, which involves a lengthy struggle over the scientific assessment of the drug's health risk and acceptability of the injectable drug's use. In this struggle, the FDA, the federal government's drug licensing agency, has limited authority to manage the drug's risk and is one participant in a fragmented system of drug risk management that includes The Upjohn Company, physicians, and state judges and legislators. Depo-Provera's odyssey joins its national controversy over its contraceptive approval to its s ... More
The odyssey of Depo-Provera is a study of the politics of contraceptive drug risk management, which involves a lengthy struggle over the scientific assessment of the drug's health risk and acceptability of the injectable drug's use. In this struggle, the FDA, the federal government's drug licensing agency, has limited authority to manage the drug's risk and is one participant in a fragmented system of drug risk management that includes The Upjohn Company, physicians, and state judges and legislators. Depo-Provera's odyssey joins its national controversy over its contraceptive approval to its state civil and criminal legal experiences, which take the form of three overlapping stories told by Judith Weisz, Anne MacMurdo, and Roger Gauntlett. At the center of each of their stories is a trial.Judith Weisz chaired the FDA's Depo-Provera Public Board of Inquiry, a science court; Anne MacMurdo was the plaintiff in a state products liability suit against The Upjohn Company; and Roger Gauntlett, the defendant in a state statutory rape trial. Together their stories join the twenty-five-year national controversy over Upjohn's FDA application to have the drug licensed as a female contraceptive to the state medical malpractice and products liability issues raised by its contraceptive use and the criminal justice issues raised by its use as a probation and parole condition for sex offenders. Together they tell a collective story that provides an agenda for the principal participants to more effectively manage Depo-Provera's health risk and for the FDA to seriously consider banning the drug.
Keywords:
medical malpractice,
parole condition,
probation condition,
products liability,
risk acceptability,
risk assessment,
risk management
Bibliographic Information
Print publication date: 2017 |
Print ISBN-13: 9781479876990 |
Published to NYU Press Scholarship Online: January 2018 |
DOI:10.18574/nyu/9781479876990.001.0001 |