The availability of the abortion drug RU-486 could be in serious jeopardy, thanks to a petition filed last week with the Food and Drug Administration (FDA) by the American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical Association and Concerned Women for America. The petition requests that RU-486 (known as Mifeprex in the United States) be withdrawn from the market on the grounds that it jeopardizes the health and safety of women.
“The petition sets forth startling evidence that the FDA violated repeatedly its own procedures and safeguards to bring this drug to market,” said Cathleen Cleaver, spokesperson for the Pro-Life Secretariat. “The evidence suggests a process dominated by politics, with women’s health a secondary, and distant, concern.”
“This petition proves beyond a shadow of doubt that the Clinton-Gore Administration cut far too many corners in getting this deadly drug to market,” said Olivia Gans, director of American Victims of Abortion, an outreach of the National Right to Life Committee.
“We now see the consequences of that politically dictated rush to approval — two women dead, another 21-year-old with a heart attack and women with ruptured fallopian tubes and dangerous infections.”
The standard side effects of RU-486, which were well known prior to the FDA’s approval, are bleeding, pain, nausea, vomiting and diarrhea spread out over several days and weeks.
The National Right to Life Committee reports that the severity of these complications has lead to a number of women ending up in the hospital requiring emergency surgery. The petition demonstrates that the injuries and deaths associated with RU-486 may be the “tip of the iceberg.”
“Under pressure from the abortion lobby and its allies in the medical establishment, just prior to the 2000 elections, the Clinton-Gore FDA dropped a number of requirements that, while they would not have made the drugs safe, would have offered women some limited degree of protection,” said Gans.
The original protocol called for an ultrasound which would have dated the pregnancy and diagnosed ectopic pregnancies. It also called for training requirements that would have helped in determining if there was anything in a woman’s medical history that could make the abortion drug combination particularly dangerous to her.
“So many rules were bent or broken that the most responsible course of action would be to rescind approval of this dangerous drug,” Gans said. “At a minimum, distribution of the drug ought to be suspended while the original approval process is legally scrutinized and a new, unbiased thorough medical review is conducted of the safety and efficacy of these drugs and the current protocol.”
Cleaver said 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.
Mifeprex may only be used on healthy mothers with healthy pregnancies, so there is no way to justify approval of this drug for a life-threatening illness, she said. “The irony here is hard to ignore: the very purpose for this drug is lethal, to end the life of a healthy child in the womb.
We agree with Cleaver’s assessment. 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.
Extensive information on the abortion drug RU-486 can be found at www.nrlc.org/RU486/ru486info.html
(This article courtesy of the Arlington Catholic Herald.)
