FDA Approves Abortion Pill

The Food and Drug Administration decision ends a 12-year battle to bring the abortion pill to the United States. According to the Population Council the drug, known as RU-486 in France where it was developed, has been approved in 15 countries and used by 620,000 European women.

Supporters say approval of the drug here could transform abortions in the U.S. — allowing more privacy — but opponents say the drug is not as safe as it’s being billed and women need to know the risks. "One in 100 women are going to require medical intervention including hospitalization," says Wendy Wright of Concerned Women For America. But approval of the abortion pill, marketed as mifeprex, is hailed as a major victory by abortion rights advocates. "The early abortion pill is as significant a technical device to women’s health as the birth control pill was 40 years ago," says Gloria Feldt of Planned Parenthood.

For years, the abortion pill has been mired in a political firestorm. Demonstrators have descended on abortion clinics across the country, including the one in Dobbs Ferry, site of one of the clinical trials.

Approval of mifeprex now means non-surgical abortions can be done at a number of facilities, not just clinics. "For women, I think it means safer access to early abortion in this country," says Dr. Rachel Marsh, the head of reproductive choice at NYU Medical Center. She adds that women will likely encounter fewer pickets because abortion sites will be spread out to include doctors’ offices.

Mifeprex can only be used to end early pregnancy — seven weeks or sooner. And it takes longer to work than a surgical abortion. While a surgical abortion takes about 10 minutes, the abortion pill takes one to three days and requires 3 trips to the doctor. On day one, a woman takes three mifepristone pills to block a hormone needed for pregnancy. Two days later she takes another drug misprostol to cause uterine contractions and expel the fetus. And finally on day 15, she returns to the doctor for a follow-up visit to make sure the abortion was successful. The drug can cause nausea in addition to bleeding. Among 2100 women safety tested, four experienced bleeding so heavy they required transfusions. While the studies show the abortion pill is up to 95% effective, 2 to 5% of women will still have to undergo surgical abortions.

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