Archbishop's web site Denver Catholic Register Parishes Catholic Pastoral Center
October 4, 2000
RU-486 approval seen as capitulation to abortion
By Nancy Frazier O'Brien
WASHINGTON (CNS) - Approval of the French abortion drug RU-486 for use in the United States will serve to "further numb our consciences to the violence of abortion and the taking of innocent human life," the head of the U.S. bishops' pro-life office said Sept. 28.
Gail Quinn, executive director of the bishops' Secretariat for Pro-Life Activities, said the approval given earlier that day by the Food and Drug Administration was "the last in a series of capitulations to abortion advocates who dismiss serious concerns about the drug and its effects."
The process by which an RU-486 abortion takes place will involve three visits to the doctor, including a follow-up two weeks after the first drug is taken.
At the first visit, the woman receives 600 mg of mifepristone by mouth. Two days later, she takes 400 mcg (micrograms) of misoprostol, a prostaglandin. The drug combination then cuts off nourishment for the unborn child and induces uterine contractions, causing the unborn child to be expelled.
The third visit to the doctor is to determine whether the abortion has actually taken place.
"Many have misleadingly promoted mifepristone as a panacea," said Quinn. "In reality, chemical abortion is an intense, three- to 15-day regimen involving multiple office visits and a combination of drugs with the possibility of life-threatening complications."
Gloria Feldt, president of Planned Parenthood, said the FDA approval would "create a new era for choice for women" in America, where more than 1.3 million surgical abortions are performed each year.
"The church and the pro-life community," said Quinn, "will continue to speak the truth about this deadly drug, while ministering to women who are in a crisis situation or who suffer after an abortion."
Judie Brown, a Catholic who heads the American Life League, also pledged to continue efforts against RU-486, which is known generically as mifepristone and is used along with a prostaglandin drug to cause abortion in the first few weeks of pregnancy.
"We will shout it from the rooftops: RU-486 kills innocent human persons," Brown said. "The U.S. Congress must resolve to conduct oversight hearings at once so that the Food and Drug Administration is held accountable for this raw, inhumane decision that will destroy babies and maim women."
In announcing its approval of mifepristone, which is to be marketed under the name Mifeprex, Dr. Jane E. Henney, U.S. commissioner of food and drugs, said the decision was based on "the FDA's careful evaluation of the scientific evidence related to the safe and effective use of this drug."
"The FDA's review and approval of this drug has adhered strictly to our legal mandate and mission as a science-based public health regulatory agency," she added.
Danco Laboratories in New York was expected to have the drug on the market in about a month. It would be sold directly to doctors and not through pharmacies. The National Abortion Federation, which accredits abortion providers, says it has 240 member clinics ready to offer the abortion drug, which was expected to cost about the same as a surgical abortion.
Vicki Saporta, executive director of the National Abortion Federation, said the FDA approval marked "a milestone in the history of abortion in America."
But Joseph M. Scheidler, executive director of the Pro-Life Action League, called Sept. 28 "a black day in the history of the FDA and women's health."
RU-486 "is a deadly poison to a tiny, defenseless unborn baby," he said, "and it can be lethal to the child's mother as well."
The FDA placed some restrictions on use of mifepristone, requiring doctors who use the drug to be trained in surgical abortions or to have plans in advance to provide such care through others.
Absent from the regulations, however, was a requirement for doctors who plan to use RU-486 to sign a registry. Abortion providers had argued when that idea was floated by the FDA earlier this year that such a registry could make doctors who use RU-486 the targets of pro-life demonstrators.
The FDA also said each woman receiving mifepristone must be given a guide that clearly explains how to take the drug, who should avoid taking it, and what side effects can occur.
The agency said RU-486 should not be used in cases of confirmed or suspected ectopic pregnancies, when a intrauterine device is in place, or by those with bleeding disorders or chronic failure of the adrenal glands, those receiving long-term therapy with corticosteroids or those allergic to mifepristone or prostaglandins. Women who smoke more than 10 cigarettes a day are warned that its effect on heavy smokers is not known.
The FDA also mandated that certain follow-up studies be conducted by the Population Council, which holds the U.S. rights to the drug. These studies would: look at whether doctors were providing surgical abortions when needed or referring to others; whether the patient agreement was being properly signed by doctors and patients and placed in the patient's medical record; and what happens in cases of the "rare ongoing pregnancies after treatment with mifepristone in the U.S."
