WASHINGTON (BP)–The federal government should rescind its approval of RU 486, three pro-life organizations have asserted after conducting a lengthy investigation of the approval process and early use of the controversial abortion drug.
Concerned Women for America and two physicians groups have filed a petition with the Food and Drug Administration calling for immediate revocation of its September 2000 approval of RU 486. CWA, as well as the Christian Medical Association and the American Association of Pro-life Obstetricians and Gynecologists, charged the FDA had violated federal law and its own standards in approving the drug. That flawed process threatened the lives and health of women, resulting in two deaths and other injuries during a 3 1/2-year period of its use before and after approval in the United States, they said.
“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,” CWA President Sandy Rios said in a written statement. “This is a shameful episode for a once-trusted institution.”
Donna Harrison, a spokeswoman for AAPOG, said her organization had “carefully reviewed RU 486 and found it to be dangerous. To safeguard the health of American women, this drug must be removed from the market.”
Rios charged the FDA with approving the abortion drug for political reasons, an accusation made by pro-lifers against the federal government often in the 1990s.
RU 486, also known as mifepristone, is used with another drug to induce abortion normally in the first seven weeks of pregnancy. Mifepristone, which uses the trade name Mifeprex in this country, causes the lining of the uterus to release the tiny baby, who usually suffocates or starves to death.
The other drug, a prostaglandin, is taken two days after mifepristone and causes the uterus to contract, expelling the child. When the FDA approved Mifeprex, it required the anti-ulcer drug misoprostol to be used to eject the pre-born baby. Cytotec is the trademark name for the drug mandated for expelling the baby in the RU 486 process.
When the FDA approved RU 486, it followed a controversial effort that took nearly eight years. The first Bush administration had refused to allow importation of RU 486, which was known as the French abortion pill because of its development in France. On his second full day in office in January 1993, President Clinton initiated the process to drop the import ban on the drug.
The Southern Baptist Ethics & Religious Liberty Commission and other pro-life organizations had fought against RU 486’s introduction into this country long before Clinton’s action. Before the FDA approved RU 486, pro-lifers warned that it not only kills a child but poses a risk to the physical and psychological health of women.
The petitioners, as well as other opponents of the drug, hope the Bush administration will tackle the controversial issue. They cite the early 2001 testimony of Tommy Thompson, who signaled in his confirmation hearing to be secretary of Health and Human Services he planned to review FDA approval of RU 486.
“This petition gives the Bush administration ample evidence and opportunity to begin its own investigation,” said Carrie Gordon Earll, bioethics analyst for Focus on the Family, in a written release. “To do any less would raise questions about the administration’s sincerity.”
The Population Council, which holds the U.S. patent to RU 486, expressed doubt the Bush administration would pressure the FDA. “The FDA is not the same thing as the executive wing of the White House,” Population Council spokeswoman Beverly Winikoff told CNSNews.com.
Before filing the petition, the pro-life organizations carried out a 22-month investigation that included researching 8,000 documents released by the FDA. Their allegations in the petition include:
— The clinical trials were neither adequate nor properly controlled.
— The regimen approved for use of RU 486 did not incorporate some safeguards used in the trials, including the requirement of ultrasound tests.
— The agency failed to require trials for adolescents, even though they are using the drug.
— Abortion-rights advocates influenced the approval process.
— The approval of an off-label use of misoprostol was unprecedented.
After the FDA approved misoprostol (Cytotec), the manufacturer, Searle, sent a letter to 200,000 health-care providers to remind them it had not studied it as an abortion-inducing drug, according to The Weekly Standard.
In April of this year, the FDA posted on the Internet new information on some adverse effects on women using the two-drug regimen, according to the three pro-life petitioners. At least two women had been afflicted by ruptured ectopic pregnancies, and one of them had died. A woman died from a bacterial infection, and another had suffered a “serious systemic bacterial infection.” Also, a 21-year-old woman had a heart attack three days after completion of the regimen. Numerous injuries, including life-threatening ones to two 15-year-old girls, also had been reported to the FDA.