Sept. 28, 2000 (Washington) -- In a long-awaited milestone action, the FDA Thursday approved RU-486, the pill that will provide American women who are within the first 7 weeks of pregnancy a nonsurgical abortion option.
Though the pill will not be stocked in pharmacies, it is expected to be available within 1 month through certain doctors' offices and clinics. Women who take the medication must make at least three visits to a doctor over a 2-week period and take another drug to assist the abortion. The total cost, reported to be $300, is the same as a surgical abortion.
The drug, also known by its generic name, mifepristone, is being marketed by Danco Laboratories under the name Mifeprex. Mifeprex works by blocking progesterone, a hormone that is essential for pregnancy. When progesterone is blocked, the lining of the uterus that builds up during pregnancy softens and disintegrates.
In announcing the approval, the FDA was diligent in striking a strictly neutral stance on an issue that pits many women's rights advocates against those with moral objections to abortions.
"The approval ... is the result of the FDA's careful evaluation of the scientific evidence related to the safe and effective use of this drug," said agency commissioner Jane Henney, MD.
Abortion advocates were overjoyed by the FDA's decision, a landmark in a long and controversial saga over the drug's availability in this country. Gloria Feldt, president of the Planned Parenthood Federation of America, called the approval "a historical moment, comparable to the arrival of the birth control pill 40 years ago."
Kate Michelman, president of the National Abortion Rights Action League (NARAL), the political arm of the pro-choice movement, called the new option "one of the most significant advances in women's reproductive health that we have seen in decades."
But RU-486 has its share of powerful opponents among those who oppose abortions, including Republican presidential candidate George W. Bush. "I think the FDA's decision to approve the abortion pill RU-486 is wrong," he said. "I fear that making this abortion pill widespread will make abortions more and more common, rather than more and more rare." In contrast, Democratic presidential candidate Al Gore supports RU-486. More than 1.3 million abortions occur each year in this country.
The National Right-to-Life Committee expressed outrage over a published report -- from earlier this month in the Wall Street Journal -- that the drug would be manufactured in China, where the government mandates some abortions. Danco won't say where the drug is being manufactured.
"It's a very safe, very effective medication," Vicki Breitbart, EdD, MSW, associate vice president for clinical services and director of the clinician training initiative at Planned Parenthood in New York City, tells WebMD. "Mifepristone ... has been used by millions of women around the world, so we have a lot of information with respect to safety and efficacy."
More than 600,000 women have used the pill in Europe. It has been available for more than a decade in France, and more recently in Britain, Sweden, and other countries. More than 2,000 women have taken the medication in the U.S. as part of its clinical testing.
While the pill may provide women greater privacy and eliminate the need for surgery and anesthesia through a standard abortion, taking it is a somewhat involved process. A woman must first take Mifeprex in an initial session with a doctor that includes signing a detailed patient consent form. Two days later, she must return to the office or clinic; if she is still pregnant, she must take a second pill, the FDA-approved misoprostol, which causes contractions in the uterus. That drug forces the early embryo and the lining from the womb.
Two weeks after her initial doctor visit, a woman must again return to confirm that the medications succeeded in ending the pregnancy. The combination of the two drugs is about 92-95% effective in ending an early pregnancy, Danco said.
Mifeprex is separate from the FDA-approved "morning after" pill, which women can use to prevent pregnancies up to 72 hours after unprotected sex. According to Danco, "Mifeprex can be taken between the time a woman knows she is pregnant and up to 49 days after the beginning of her last menstrual period."
The drug does have side effects -- largely bleeding and cramping. The FDA warns that bleeding may occur for 9-16 days. The agency cautions that in about 1 of 100 women, bleeding can be heavy enough to require a surgical procedure known as curettage.
FDA is limiting the physicians who may prescribe Mifeprex. The agency says that doctors who prescribe the drug must be able to date pregnancies accurately. They must also be able to diagnose tubal pregnancies, since women with tubal pregnancies may not take the drug.
FDA also requires that physicians be prepared to provide women any necessary surgery, or arrange for those procedures in the case of incomplete abortion or severe bleeding. Doctors also must ensure that women who take the drug have access to emergency care.
The agency first issued an "approvable" letter for the drug in 1996, which indicated that most -- but not all -- conditions for approval had been met.
But since then, the drug has had a tough time finding its way to market. Congress has repeatedly tried to block FDA's review of the drug, even as ownership of the rights to the medication changed hands. In 1989, the Bush Administration had banned Americans from importing RU-486 for personal use, a ban that Clinton lifted in 1993.
"Today's action by the FDA assures that women across the country will be able to make informed choices about the use of this drug -- choices based on solid scientific evidence," said Richard G. Roberts, MD, president of the American Academy of Family Physicians.
But anti-abortion advocates dread the potential impact of the approval. "The FDA's approval of RU-486 could result in more abortions and, therefore, more dead babies and injured women," Teresa Wagner, a legal analyst at the Family Research Council, said. "It's not only unprecedented for the FDA to approve a drug that has no therapeutic effects, but it's unethical."
The FDA has posted information about Mifeprex at www.fda.gov/cder/drug/infopage/mifepristone/default.htm.