Drug regulation in the United States and the United Kingdom: the Depo-Provera story.
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.
D000818:Animals; D002273:Carcinogens; D003271:Contraceptive Agents, Female / Q000009:adverse effects; D004345:Drug Industry; D004812:Epidemiologic Methods; D005260:Female; D006077:Government Agencies; D006291:Health Policy; D006801:Humans; D008525:Medroxyprogesterone / Q000009:adverse effects / Q000031:analogs & derivatives*; D017258:Medroxyprogesterone Acetate; D010818:Practice Patterns, Physicians'; D011358:Product Surveillance, Postmarketing; D012306:Risk; D006113:United Kingdom; D014481:United States; D014486:United States Food and Drug Administration
D002273:Carcinogens; D003271:Contraceptive Agents, Female; D017258:Medroxyprogesterone Acetate; D008525:Medroxyprogesterone