One element that is sometimes lost in the abortion debate is the effect it has on women’s health. When the Clinton administration approved the use of RU-486—the abortion pill, health professionals like Lexington’s Dr. David Hager saw red flags.

Hager, an obstetrician/gynecologist, is under consideration by the Bush administration to be a member of the Advisory Committee on Reproductive Drugs in Women. If appointed, he hopes to bring attention to health problems with what he calls "chemical abortion." He said the decision to approve RU-486, also known as Mifeprex, was "politically motivated and …pushed by the pro-abortion people" without the battery of reliable studies the Food and Drug Administration (FDA) usually demands of new drugs it releases to the American public.

Hager said consequences of Mifeprex sometimes include hemorrhage, serious infection, ruptured ectopic pregnancy, and death. Last April, the FDA and Danco, the pharmaceutical company that distributes Mifeprex, issued a medical alert to doctors indicating the drug’s potential problems, although as yet, Mifeprex has not been removed from the market.

That’s why Hager, in conjunction with the Christian Medical Association, Concerned Women for America, and the American Association of Pro-Life Obstetricians and Gynecologists, has filed a Citizen’s Petition with the FDA, asking that Mifeprex be removed from public use until further studies can verify its safety.

"Although we are pro-life organizations," Hager said, "we have filed this petition out of our concern for the health and well-being of women and their unborn/newborn children. We hope to draw attention to the fact that this medication was approved in an unusual way."

The FDA, during the Clinton Administration, approved the drug with its "Accelerated Approval Process" under Subpart H. Subpart H, Hager said, "has been reserved for drugs that are used for extremely threatening conditions, such as cancer and AIDS, and for situations where no better agent exists on the market. Certainly, pregnancy termination is not a life-threatening condition, and there is good evidence that surgical abortion is actually more effective than medical abortion so the latter is not a factor either."

In addition, Hager said, the Mifeprex was approved after review of two French studies and one American study—none of which were randomized, controlled trials, usually required for FDA approval. Even the French pharmaceutical company who originally marketed RU-486 in Europe, doubted the drug would pass rigorous FDA standards and because of that, originally refused President Clinton’s request to make it available here.

In approving Mifeprex, the FDA also violated its own guidelines in regard to "The Pediatric Rule," Hager said. The rule says that "drugs are not to be approved for sale in this country unless they have been tested in children and adolescents if they are to receive the drug." Hager cited reports of two 15-year-old girls who developed serious pelvic infections after using Mifeprex.

There are also health risks for babies who survive attempted chemical abortion with Mifeprex, according to Hager. After 7 weeks gestation, Mifeprex has a failure rate of 15-20 percent. Some surviving babies were born with birth defects, including malformed limbs.