October 21, 2005 -- Former FDA Women’s Health Director Comments on Plan B

In comments published in today’s issue of the New England Journal of Medicine, the former director of the Office of Women’s Health at the federal Food and Drug Administration (FDA) says she resigned from the FDA August 31 after the agency delayed indefinitely a decision about whether emergency contraception—Plan B—should be switched to nonprescription status. “I believed that in doing so, they were disregarding the scientific and clinical evidence and the established review process and were taking an action that harms women’s health by denying them appropriate access to a product that can reduce the rate of unplanned pregnancies and the need for abortions,” Susan Wood said. Wood noted that the FDA has previously taken many actions to safeguard women’s health, including the banning of thalidomide after that drug was found to cause birth defects; regulation of medical devices such as the Dalkon Shield intrauterine device which injured many women; and setting standards for and inspecting mammography facilities. She noted that the FDA developed its first package inserts for patients in response to calls from women’s health advocates for more consumer information about oral contraceptives. She said, however, that an August 26, 2005, announcement by then-FDA commissioner Lester Crawford that the agency would delay a decision on Plan B while it asks for public comment on possible new regulations led to her resignation. Crawford has since resigned as FDA head; a new commissioner has not yet been named, and the FDA hasn’t so far published the proposed new Plan B regulations. Wood’s comments, “Women’s Health and the FDA,” are available at "http://content.nejm.org/cgi/content/full/353/16/1650.