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Early Abortion Pill Approved by FDA

WebMD Health News

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."

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