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FDA Approves Abortion Pill

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NATALIE ALLEN, CNN ANCHOR: The hour's top story is a breakthrough to some, a monstrosity to others. It's the so-called abortion pill, known also as RU-486, or Mifepristone. Twelve years after it went on sale in France, the U.S. Food and Drug Administration today approved its use by American doctors on American women. It could be shipped to doctors' offices nationwide by the end of next month.

LOU WATERS, CNN ANCHOR: The abortion pill's developer wanted no part of the United States market because of the volatile nature of the U.S. abortion debate.

We get more on the pill's history, now, from CNN's Rhonda Rowland.

(BEGIN VIDEOTAPE)

RHONDA ROWLAND, CNN CORRESPONDENT (voice-over): The road to this week's FDA action has been a long one for the drug. It's medical name is mifepristone.

Twenty years ago, a French company, Roussel-Uclaf, developed the drug, also known as RU-486. It was later made available to women in France, the United Kingdom and Sweden.

In 1993, the Clinton administration lifted a Bush administration ban that prevented American women from importing RU-486. Because of abortion politics, Rousel-Uclaf would not agree to distribute the drug in the United States. In 1994, it donated the patent rights to the population counsel so the non-profit family planning group could study it and find a willing manufacturer.

DR. MITCHELL CREINEN, UNIVERSITY OF PITTSBURGH: The studies in the United States were just a continuation of studies that had been done in Europe and didn't show much different than what we already knew, which was that mifepristone, combined with another medication, like misoprostol, is a safe and effective option for early abortion.

ROWLAND: Misoprostol, a hormone-inducing drug, is already FDA approved for the treatment of ulcers. In 1996, the food and drug administration issued an approvable letter for mifepristone that acknowledged the drug was safe and effective.

But the FDA withheld marketing approval until manufacturing and labeling information was provided -- a major glitch, since the population counsel has not yet found a company to make the drug.

In 1997, another delay for the pills' advocates. A manufacturer who agreed to produce mifepristone for American women, backed out. Since then, a new pharmaceutical company, Danco Laboratories, stepped in. Danco plans to market mifepristone, and while a manufacturer has been found, its name remains a secret.

Now that mifeprex has been FDA approved, it will be at least a month before it's on the market.

Rhonda Rowland, CNN.

(END VIDEOTAPE)

WATERS: Big information on this story at cnn.com. You can follow a timeline, beginning with the abortion pill's development 20 years ago. You also can go on the message board to give your opinion on the pill's approval.

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