AAPLOG Files Citizen Petition on Mifepristone (Mifeprex) with FDA
Holland, Michigan—The American Association of Pro-Life Obstetricians and Gynecologists, together with the Christian Medical Association and Concerned Women for America, filed a response on August 20 with the Food & Drug Administration requesting immediate revocation of the approval of Mifeprex (RU-486), the abortion pill. The petition is based on evidence that the FDA approved the drug in violation of its own regulations and evidence that Mifeprex is harming American women.
Donna J. Harrison, M.D., chairperson, Subcommittee on Mifeprex, American Association of Pro-Life Obstetricians and Gynecologists, stated, “As physicians who care about the life and health of the mother, as well as her unborn baby, the American Association of Pro-Life Obstetricians and Gynecologists has carefully reviewed RU-486 and found it to be dangerous. The recent deaths in Canada and the United States during RU-486 abortions support our findings. To safeguard the health of American women, this drug must be removed from the market.” In the course of its approval of Mifeprex, the FDA failed to carry out its mission of ensuring that only drugs shown to be safe and effective are approved for marketing. The Citizen Petition is the result of a 22-month investigation, which included combing through 8,000 documents released by the FDA. The Petition details numerous violations of the agency’s standards and rules, and reports medical complications suffered by women who took Mifeprex. David Hager, M.D., spokesman for the Christian Medical Association, said, “As an obstetrician/gynecologist, I have a passion for the health and well-being of women and their unborn/newborn offspring. The use of any medication that puts the life and health of either of these individuals at risk implores me to call for a thorough and exhaustive evaluation, in an evidence-based manner, on such drugs. RU-486 is such an agent, posing risks to women and potentially to their unborn babies, pressing me to call upon the FDA to reconsider its ‘fast-track’ approval of Mifeprex.” Sandy Rios, president of Concerned Women for America, stated, “Whether people are pro-life or pro-choice, the blatantly indefensible approval of RU-486 by the FDA has resulted in harm to women, and in some cases death. The FDA’s unprecedented action of approving a drug in violation of its own regulations has endangered the lives of American women for the sake of political expediency. “Concerned Women for America is dedicated to seeing that the previously high standards of the FDA are restored and that the American public is once again safe from politically driven bureaucrats whose irresponsible actions have unnecessarily cost the lives and health of trusting and otherwise healthy women. This is a shameful episode for a once-trusted institution.”
It is important that the FDA be notified of any adverse effects that have occurred with the use of Mifeprex. Both physicians and others can report adverse effects directly to the FDA at www.fda.gov/medwatch.
Links to Other Related Websites:
- For background, see FDA’s Mifeprex webpage
- For background, see RU486Facts.org