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Drug Regulation in the United States and the United Kingdom: The Depo-Provera Story
Abstract
In 1984, both the United Kingdom and the United States received recommendations from panels of experts specifically convened to consider the merits of Depo-Provera (depot medroxyprogesterone acetate [DMPA]) as a long-term contraceptive agent. This study compares the final reports written by these panels. We explore why, despite access to essentially the same data, the U.K. panel recommended marketing approval but the U.S. Public Board of Inquiry did not. We conclude that differing national policies helped shape the interpretation of the data and thus the divergent outcomes.
- antineoplastic agents, carcinogens
- contraceptive agents, female
- Depo-Provera
- drug evaluation
- drug regulatory policy
- drug screening
- endometriosis
- Great Britain
- long-term contraceptive
- progestogens
- risk benefit analysis
- United States
- United States Food and Drug Administration
- uterine neoplasms
Article and Author Information
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▸From The Center for the Study of Drug Development and the Departments of Psychiatry and Pharmacology, Tufts University; Boston, Massachusetts.
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▸Requests for reprints should be addressed to Barbara W. Richard, M.A.; Center for the Study of Drug Development, Tufts University, 136 Harrison Avenue; Boston, MA 02111.
- © 1987 American College of Physicians
