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FDA Approves So-Called Abortion Pill

After a long delay, the US Food and Drug Administration (FDA) today approved the abortion pill RU-486 in this country for early stage abortions without surgery. The drug has been widely used in Europe for years.


For more than a decade, it's been an option only for women overseas, but today's FDA ruling means the French abortion pill RU486 is coming to the United States


"The decision has been very firmly grounded in science and has met the standards that we expect for any drug approval," says Jane Henney FDA Commissioner.


It's the end of a long and bitter battle.


"The FDA's approval is a tremendous victory for American women," says Gloria Feldt of Planned Parenthood.


Restrictions

Abortion rights advocates consider it an even bigger victory because the drug, which will be known here as Mifeprex has been approved with few restrictions.


  • It must be given within the first seven weeks of pregnancy


  • Requires three office visits


  • May be administered by any doctor who has access to emergency services


"Women will have access all over the country to a safe simple medical abortion through their primary care doctor," says Eric Schaff, MD of the University of Rochester.


Because of the intense controversy over abortion rights, the drug's manufacturer, Danco Labs, will not reveal where it will be made, and women who took it in trials still prefer anonymity. This woman who got pregnant while on the pill felt she couldn't handle a third child.


"An unplanned pregnancy is a loss of control. And by using this method I was able to feel that I was able to get some control back," she says. "It makes it much easier physically, but nothing will ever make it easier emotionally."




How it works

Mifeprex works by blocking the hormone progesterone, which allows an embryo to attach to the lining of the uterus. Once the embryo detaches, a second drug called misoprostol is given, which causes contractions that expel it from the body.


Studies show the pill is effective 95% of the time. But 2% of women who took it experienced excessive bleeding or the need to follow up with a surgical abortion. Potential side effects have foes of abortion rights vowing to fight on with the warning: this is no magic pill:


"It is a complicated, complex and potentially deadly procedure for the mother and always a deadly procedure for her child," says Olivia Gans of National Right to Life.


Heated ethical and political debates delayed the American debut of the abortion pill. President George Bush banned its import in 1989. President Clinton lifted that ban when he took office, paving the way for today's FDA action.


Now it is expected to be available for sale within 30 days.

The abortion pill decision quickly surfaced in the presidential campaign. George W. Bush said the FDA's ruling is, quote, "wrong." Al Gore said he is, quote, "pleased," calling the FDA ruling, quote, "not about politics, but the health and safety of American women."

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