Contraceptive development and testing in the United States of America
Edelman, D.A.; Van Os, W.A.
International Journal of Fertility 35(4): 206-210
1990
ISSN/ISBN: 0020-725X PMID: 1977711 Document Number: 374714
The changing regulatory role of the FDA has affected the development of contraceptives including the IUD. This work attempts to discuss how the FDA and the government influence contraceptive development. Particular government actions led to the demise of the IUD in the US and will have long lasting effects in the US on the future of all contraceptive development by the pharmaceutical industry. This work traces the history of government regulation of contraceptives from the Pure Food and Drug Act of 1906 through the 1976 Medical Device Amendments to the Food Drug and Cosmetic Act of 1962. This act required manufactures of nonmedicated IUDs, and any other contraceptives, to conduct similar clinical trials that are required for the development of other drugs. In the US, IUD contraception has become a legal battle ground and its future is that of a condemned product. Currently no manufacturer of IUDs is marketing products in the US. This deprives US women of a safe and effective form of contraception. This work also discusses Depo-Provera and RU-486. The author's final conclusion is that the future of contraceptive research and development in the US is in doubt. The pharmaceutical companies of Western Europe have proven their commitment and ability in this area in the last decade and will continue to do so for the next.