FDA approves controversial abortion pill for US use
Anti-abortion activists worry about health risks; proponents say it's a surgery alternative.
WASHINGTON — The decision by the Food and Drug Administration yesterday to approve the use of the abortion pill RU-486 could fundamentally change the debate over one of the most divisive social issues in America.
It marks a major victory for those who battled for 12 years to bring the early-abortion method to the United States. Coming in the midst of an election year, the FDA's decision is also sure to generate fierce new controversy in the presidential campaign.
Republican candidate George W. Bush opposes abortion. His father's administration banned RU-486 from this country in 1989. The abortion-rights Clinton-Gore administration worked for seven years to bring RU-486 here.
Proponents say the pill, which has been used by millions of women in 13 countries, could transform abortion in the US by making it more accessible and more private. But it can be used only in the earliest weeks of pregnancy. Anti-abortion organizations have fought to keep RU-486 out of the US since the drug debuted in France in 1988. They pledged to continue the fight.
To ensure the pill is used accurately and safely, the FDA mandated that women be given special brochures called "MedGuides" explaining who is eligible for a pill-caused abortion and what side effects to expect. They must make three trips to the doctor to undergo the procedure.
RU-486, now known by its chemical name mifepristone, can be used only within the first six to seven weeks of pregnancy. The FDA will allow mifepristone to be distributed only to doctors trained to accurately diagnose the duration of pregnancy. The FDA also restricted mifepristone's use to doctors who can operate in case a surgical abortion becomes necessary.
Studies show mifepristone is 92 percent to 95 percent effective in causing early abortion, but can cause painful side effects.
A small New York company, Danco Laboratories, will market mifepristone under the brand name Mifeprex. It should be available in about a month. Abortion-rights proponents pushed the FDA to approve mifepristone, arguing a pill-caused abortion offers a surgery alternative that feels more like a miscarriage and typically is offered earlier in pregnancy than surgical abortion.
The vast majority of today's 1.3 million annual US abortions are surgical. Health experts say mifepristone won't increase abortions - that didn't happen in Europe.
But the FDA's formal approval may encourage more doctors who don't offer surgical abortions to offer the pill, thus making it easier for women, particularly in rural areas, to get an abortion without traveling hundreds of miles or entering surgical clinics often staked out by protesters.
The National Abortion Federation, which accredits abortion providers, said 240 of its member clinics were already prepared to offer Mifeprex, and it is training other physicians in how to use the pill.
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