WASHINGTON (August 21, 2002) –- A petition filed yesterday with the Food and Drug Administration (FDA) seeks a ruling which would withdraw the abortion drug RU-486–known as Mifeprex in the United States–from the market on the grounds that it jeopardizes the health and safety of women. The petition was filed by the American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical Association, and Concerned Women for America.
"The petition sets forth startling evidence that the FDA repeatedly violated its own procedures and safeguards to bring this drug to market," said Cathleen Cleaver, Esq., spokesperson for the Pro-Life Secretariat of the United States Conference of Catholic Bishops (USCCB). "The evidence suggests a process dominated by politics, with women's health a secondary–and distant–concern."
For example, the FDA approved Mifeprex under a fast-track policy designed for rapid approval of life-saving experimental treatments for patients with lethal diseases, such as AIDS or cancer, even when the treatments have not been thoroughly tested.
"Since Mifeprex may only be used on healthy mothers with healthy pregnancies, there is no way to justify approval of this drug for a life-threatening illness," Cleaver said. "In fact, the irony here is hard to ignore: the very purpose of this drug is lethal–to end the life of a healthy child in the womb."
The petition asserts that current use of Mifeprex subjects women to dangers of massive bleeding, infection, the need for transfusions, and the misdiagnosis of ectopic pregnancies. "Several recent reports cite women dying or suffering serious injury when using the drug according to the regimen approved by the FDA," Cleaver noted. "These events must be taken seriously by the FDA."
"There is no reason to place more women at risk of death or serious health consequences. For the good of women and children, Mifeprex should be withdrawn immediately," Cleaver said.