The drug is expected to be available through doctors in the Dallas area in about a month.
Called by its generic name mifepristone, or its French name RU-486, the drug can be prescribed for pregnant women within 49 days of the beginning of their last menstrual period. Those who use it must take one dose of the drug, followed two days later by a second drug, misoprostol, a previously approved ulcer-prevention drug. About 90 percent of the women who used the combination in clinical trials ended their pregnancies within 24 hours of taking the second drug.
While feminist groups and others were applauding the FDA's decision, opponents made it clear that the debate over the drug was far from over.
In several hastily called news conferences Thursday, congressional leaders vowed that they would find a way to slow the distribution of mifepristone. Republican presidential candidate George W. Bush also weighed in on the issue, calling the FDA's decision "wrong." Vice President Al Gore, the Democratic presidential nominee, said he was pleased with the agency's endorsement.
Nowhere was the approval more celebrated than among those groups that have decried the lack of abortion services available to American women.
Gloria Feldt, president of the Planned Parenthood Federation of America, called the new drug "the beginning of a new era" and promised that doctors at its Planned Parenthood centers around the country would begin offering it to patients in about a month.
"Science has prevailed over politics," she said in a statement. "Because many health providers who do not now offer abortions have said they would like to provide mifepristone, more women in more places should be able to access this nonsurgical early option."
The drug was developed in France in 1982 and later donated by its manufacturer, Roussel Uclaf, to an international nonprofit group, the Population Council, in hopes of getting it approved in the United States. The New York-based council conducts public health research and was started by John D. Rockefeller III.
Use of the drug was prohibited in 1989 by the FDA. The government in 1993 began working to bring the drug to America.
The Population Council has contracted with Danco Laboratories to manufacture, market and distribute the drug. Pam Long, a Danco spokeswoman, said it would be available under the brand name Mifeprex in about a month at doctors' offices. It will not be sold through the Internet or even at local drugstores, she stressed.
The Rev. Flip Benham, national director of Operation Save America, formerly Operation Rescue, said his group would picket any place the drug was being used.
"We'll go to any drugstore or doctor's office that wants to kill a baby by chemical extermination," he said. "The battle will be won on the streets."
Informed that some anti-abortion activists were planning to picket pharmacies that carried the drug, Ms. Long said, "They can sure do that. It won't work." However, the company has taken the extra precaution of not disclosing the location of the plant where the drug is being manufactured in hopes of preventing any conflicts there.
Leaders of several anti-abortion groups say they remained opposed to mifepristone and would focus their efforts on the drug's side effects because the clinical trials had documented a variety of complications, including severe bleeding in 1 percent of the women who had used it.
Laura Echevarria, a spokeswoman for National Right to Life in Washington, D.C., said her organization would fight "to protect American women" from mifepristone.
"We were anticipating this happening, but when it did happen, we were still disappointed," she said. "We know that somewhere along the way, someone may very well be hurt by it and someone may very well die by it."
Joe Kral, legislative director of Texas Right to Life, said his group would call upon the Texas Legislature to limit the drug's use because the "health and safety of women should be the Number 1 priority of this state."
A spokeswoman for the Population Council maintained that any complications from using mifepristone were being exaggerated by abortion opponents.
"Basically you're producing a miscarriage, or something similar to a miscarriage," said spokeswoman Sandra Waldman. "Many physicians are capable of treating miscarriages. The physician has to know to look for complications and how to handle them."
FDA Commissioner Jane E. Henney said the approval was granted only after mifepristone was found to be safe and effective in clinical trials involving about 2,000 women in the United States. The drug has been on the market for a decade in Europe, and about 500,000 women have used it there.
In approving its use, the FDA took the extra step of requiring that doctors provide their patients with detailed information about how the drug works, including a warning that it causes cramping and bleeding. The agency noted that 7 percent of the women involved in the U.S. trials later required a surgical abortion for problems including the incomplete expulsion of the embryo and uncontrolled bleeding. In 1 percent of the women, the pregnancy continued and had to be aborted as well.
The agency also specified which physicians would be allowed to prescribe the drug, although it backed off the idea of requiring a national registry of such doctors after physician groups lobbied against it.
According to the guidelines, any doctor may prescribe the drug as long as he or she has the ability to determine the length of a woman's pregnancy and can rule out the possibility that a patient has an ectopic pregnancy, which is a condition in which the fertilized egg is growing inside a fallopian tube and must be removed surgically. Doctors also must be able to provide follow-up surgical care if it becomes necessary or make arrangements with another physician to provide it.
In June, the FDA had said it was considering limiting the number of doctors who could prescribe the abortion pill out of concern that a small percentage of women suffer complications that required surgery. At that point, the agency also considered excluding any doctor whose offices were located more than an hour from an emergency room. But the guidelines make no mention of a distance requirement for doctors' offices.
The guidelines for use of the drug did warn against prescribing it for women who had been fitted with an intrauterine device, or IUD, as well as those who had problems with their adrenal glands or had taken blood-thinning drugs or steroids.
Doctors who were involved in testing mifepristone said its usage would depend largely on its price.
"Medical abortions have been available in this country since 1993 using other drugs that were not intended to cause abortions," noted Dr. Mitchell Creinin, director of family planning at the University of Pittsburgh. "But the other drugs do not work as well as this combination of drugs. The usage will depend on how expensive it is and the laws in each state that might restrict doctors from using it."
The drug works by blocking a hormone called progesterone, which is needed for a pregnancy to continue. Basically, it causes bleeding that can last for nine to 16 days. In essence, it produces a miscarriage.
But abortion opponents say they don't buy the idea that safer makes any abortion better.
"As far as we're concerned, there's no such thing as a better abortion. It's an abortion, baby-killing by another method," said Kyleen Wright, president of Texans for Life, an Irving-based anti-abortion group that says it has 10,000 members. "I think it will increase the number of abortions some. They are projecting early sales of 3 [million] to 4 million [pills] a year."
According to the U.S. Centers for Disease Control, there were almost 1.2 million legal, induced abortions in the United States in 1997, the most recent year for which numbers are available. The Texas Department of Health estimates there were 80,000 induced abortions in the state last year.
Use in France
Defenders of the procedure say the number of abortions did not increase when the drug was approved in France in 1988.
"Where it has been available throughout Europe, they have not seen an increase, and we do not expect that here," said Kathryn Allen, spokeswoman for Planned Parenthood of North Texas. "For women who are determined not to carry a pregnancy to term, this gives them an option to take action early. We have to trust women in this country to make good decisions about their bodies."
Staff writer Charles Ornstein in Washington contributed to this report.