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RU-486 Approval Pits Science Against Politics


Rep. Tom Coburn (R-Ark.), himself a physician, said: "The character and the integrity of the Food and Drug Administration has sunk to a new low today. Not only have they spent time trying to figure out how to deal death to an unborn child, what they have done is violate their own code of ethics."

Coburn promised to introduce a new patient protection bill for women focused on the drug. The measure would require the pill to be used only by doctors qualified to handle serious abortion complications. Coburn also wants doctors who prescribe the drug and patients who get the drug to place their names in a registry as an additional safeguard.

Sen. Tim Hutchinson (R-Ark.) called for hearings to investigate the FDA's approval process, a process Hutchinson said was "tainted by politics." Although Mifeprex had been recommended for approval in 1996, issues surrounding the training of physicians and the manufacture of the drug slowed the review.

Meanwhile, to prescribe Mifeprex, the FDA says physicians must be able to provide surgical services, or arrange for those procedures in the case of an incomplete abortion or severe bleeding. Doctors also must ensure that women who take the drug have access to emergency care.

Others were quick to defend what they viewed as agency heroics. "I want ... the House of Representatives to take off its white coat and stop practicing medicine without a license," said Rep. Louise Slaughter (D-N.Y.).

Assuming that Mifeprex gets to market in the coming months, what impact might it have? According to Betsy Cavendish, JD, legal director of the National Abortion and Reproductive Rights Action League (NARAL), a women's reproductive rights group, some doctors are already trained in using the pill, and patients will be able to get it quickly.

"I think surgical abortions will diminish. I think in the next few years, 30-50% could end up being medical abortions" with Mifeprex, Cavendish tells WebMD.

However, other women's health advocates have a more conservative view. "With the restrictions requiring a surgeon backup, it will probably mean that this product will not be nearly as available as it would have otherwise," Diana Zuckerman, PhD, director and president of the National Center for Policy Research for Women and Families, tells WebMD.

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