Edition: U.S. / Global


Published: September 29, 2000

The Food and Drug Administration announced yesterday that it had approved the marketing of an abortion-inducing pill, the first alternative to surgical abortion approved in the United States.

The pill, a prescription drug, will be available to doctors in about four weeks, its distributor said.

The drug, mifepristone, or RU-486, will allow doctors like family practitioners and obstetricians to offer abortions outside of specialty clinics, and it will allow women to have abortions in the privacy of their homes up to seven weeks after their last menstrual period.

Although most women who seek abortions do not do so until later in their pregnancies, the drug has taken on immense symbolic importance for both supporters and opponents of abortion rights. Many supporters of abortion rights have said its approval will transform the struggle over legal abortion, making the procedure more accessible and more private, and stall efforts by opponents of abortion to identify women who are having the procedure and doctors who are providing it.

Approval of the drug immediately brought out the sharp contrasts in the views on abortion of Vice President Al Gore and Gov. George W. Bush of Texas. Mr. Gore said he was pleased with the decision, and Mr. Bush said it was wrong.

Dr. Jane E. Henney, the F.D.A. commissioner, said in an interview, ''Politics had no role in this decision.'' It was based, Dr. Henney said, on persuasive data showing that the drug is safe and effective.

The drug will be distributed under the name Mifeprex by Danco Laboratories of New York City, a company formed specifically to find someone to make the drug and then to market it. While Danco is marketing the drug, the company has refused to disclose the manufacturer.

Advocates of abortion rights said they were elated by the health agency's action.

''Never have I seen anything like this,'' said Gloria Feldt, the president of the Planned Parenthood Federation of America, which participated in clinical trials of the drug. ''Never has there been a drug approval that has been through such an arduous political process.''

Ms. Feldt called the drug ''the most significant technological advance in women's reproductive health care since the birth control pill.''

It was a setback for those who oppose abortions, and some of them saw it as a contradiction in Clinton administration policy.

''I think it should give people pause,'' said Dr. Richard Land, the president of the Southern Baptist Convention's ethics and religious liberty commission.

''I wonder how they square this with making abortions safe, legal and rare,'' Dr. Land said, citing an oft-repeated Clinton administration goal. ''It will make them more plentiful and less safe.''

In its announcement, the health agency set relatively few restrictions on doctors' freedom to prescribe the drug, beyond requiring that the doctors be able to determine the length of time that a woman has been pregnant and that they make sure that women who receive mifepristone have ready access to surgical abortions, should they need them.

A woman will be given written instructions on the pill's use and its side effects, which can include bleeding and cramping, headaches, vomiting or diarrhea, and her doctor must sign a statement saying they have read the instructions and will comply with them exactly. The woman must also agree to have a surgical abortion if the pills do not succeed.

A woman first takes mifepristone, which blocks the action of progesterone, a hormone required to maintain a pregnancy, and 36 to 48 hours later takes a second drug, misoprostol, which makes the uterus contract, expelling the fetal tissue. In clinical trials, the drug combination failed to result in complete abortion in about 5 percent of cases.

The F.D.A. also required that the Population Council, a nonprofit group that holds the United States patent to mifepristone, keep track of how many women suffer serious side effects and the number of cases in which the pill fails to induce abortion. The council will also audit doctors to see whether they and the women taking the drug are signing the patient agreement.

Although advocates of abortion rights have been pushing for approval of mifepristone for years, it is not clear how many American women will choose it.

The drug can be used only until seven weeks after a woman's last menstrual period, and just one-third of abortions performed in the United States occur at that stage, according to the Alan Guttmacher Institute, a nonprofit group that researches reproductive health.

Beyond that, side effects like excessive bleeding are extremely rare in first-trimester surgical abortions, and abortions are legal even into the third trimester of pregnancy in some states. Some doctors said they anticipated many women seeking an abortion would prefer the surgical approach, since the procedure usually is over in a day.

''There is no question that mifepristone is highly effective and there are good results most of the time,'' said Dr. Warren Hern, director of the Boulder Abortion Clinic in Colorado. But, Dr. Hern said, citing side effects like incomplete abortions, ''people have a way of denying these problems with the drug and saying it's a magic bullet. It's not.''

Ms. Feldt of Planned Parenthood said women in clinical trials said they liked mifepristone abortions because they felt more natural than surgical ones.

''They feel more in charge, more in control of their personal health,'' Ms. Feldt said.