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FDA Drags Feet Over Fate of RU-486Aired June 7, 2000 - 1:32 p.m. ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
KYRA PHILLIPS, CNN ANCHOR: Four months ago, federal regulators delayed approving the controversial abortion pill known as RU-486. They said they had to work out some final requirements. Now, although the FDA isn't commenting, abortion rights advocates are concerned about possible restrictions.
CNN medical correspondent Rhonda Rowland has the latest.
RHONDA ROWLAND, CNN MEDICAL CORRESPONDENT (voice-over): The so- called "abortion pill," RU-486, has been used by half a million women worldwide, but the drug known medically as mifepristone, is not yet available to American women. If it gets marketing approval from the FDA, abortion rights activists say it may only be made available with tight restrictions.
Among the proposals: a national registry of physician's providing abortions with mifepristone; physician's opting to provide the drug must be able to do surgical abortions in case the drug does not cause a complete abortion; providers must have hospital admitting privileges within an hour's drive; and a study would be set up to follow women who have had abortions with the drug regimen.
Dr. Mitchell Creinin has done extensive studies on mifepristone. He says even now, 80 percent of counties in the U.S. don't have abortion providers.
DR. MITCHELL CREININ, UNIVERSITY OF PITTSBURGH: Mifepristone will only be available from a physician, but right now there are lots of laws in many states that restrict abortion practice, that restrict the practice of medicine.
ROWLAND: Studies show when Mifepristone is followed by a second drug, misoprostol, the regimen is 92 percent effective in causing an abortion during the first seven weeks of pregnancy.
ROWLAND: A spokesperson with the National Right to Life told CNN that while the group opposes approval of Mifepristone, the restrictions are appropriate because the drug can be dangerous for the woman.
That is, Kyra, it can cause some bleeding, that's why physicians would need to be educated and woman counseled.
PHILLIPS: So where are we in the FDA approval process now?
ROWLAND: Well, it has been very complex, but right now, the ball is in the court of the FDA. The Danco group, which will eventually manufacture and also market the drug, has gotten back to the FDA to try to answer some of its concerns. The FDA now has until the end of the September to get back to the Danco group. Now, we don't know if that will mean actual approval or if they will have further questions.
So, the short answer is we just don't exactly know.
PHILLIPS: Rhonda Rowland, thank you.
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