RU-486, the FDA and Free Enterprise
Buc, Nancy L.
Law, Medicine and Health Care. 1992 Fall; 20(3): 224-225.
Nancy Buc examines some of the legal issues surrounding the introduction of RU 486 and goes on to separate legal from political considerations. She concludes that the legal problems are minimal and that the political problems are paramount. She explains that, given the research and publication to date in peer reviewed journals on the use of RU 486/prostaglandin, it is unlikely that the regimen would fail the legal criteria demonstrating safety and efficacy. In examining whether product liability issues for contraceptive and abortifacient drugs are different from those for other drugs, she points out that the question has to be seen in the context of how women's health concerns are generally addressed and "the overly protective and sexist approach" taken to drugs for women's conditions, diseases and disabilities. She concludes that the real problem is that there is no willing sponsor of the drug in the U.S. and recommends the establishment of a drug company called "Feminist Pharmaceuticals."
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