RU-486 Approval Pits Science Against Politics

From the WebMD Archives

Sept. 29, 2000 (Washington) -- The old battle over the abortion pill may be over, but a new struggle over its future in the U.S. has already begun. While the fate of most drugs is determined by sifting through reams of scientific evidence, Mifeprex (mifepristone) was different from the start.

Known widely as RU-486, the French drug was a touchstone for political and emotional, as well as scientific, debate, which now seems re-energized following Thursday's approval of Mifeprex. President Clinton, who overturned an import ban on the pill put in place during the Bush Administration, hailed the FDA's decision as a good one -- based on science.

"The FDA is basically doing its job -- it's now done its job," said Clinton.

"It's about time!" said Rep. Lynn Woolsey (D-Calif.), joining in the celebration. She insisted at a Capitol Hill news conference that the issue wasn't about morality, but protection of women's rights. "We're talking about cheering a decision that makes abortion safe and private for women."

Democrats also were quick to point out that it was a Clinton-Gore Administration that succeeded in getting Mifeprex into the U.S. over strenuous opposition from abortion foes. "I think voters, especially pro-choice women, should be very disturbed by Governor Bush's pledge to ban mifepristone," said Rep. Nita Lowey (D-N.Y.). George W. Bush said in a statement that approving Mifeprex was "wrong" and that it would make abortions more common.

The goal of many pro-choice activists is to move at least some of the estimated 1.3 million abortions performed in America out of clinics that have often been targets of protest and violence.

"[Mifeprex] makes it easier to avoid the terrorization by the thug elements of the anti-choice movement in this country who have used every opportunity to terrorize doctors and women," said Rep. Jerrold Nadler (D-N.Y.).

Meanwhile, lawmakers across the aisle assailed the FDA for allowing American women to get access to the drug, questioned the agency's approval process, and made it clear they intended to fight the move.

"RU-486 is baby poison. It is baby pesticide," said Rep. Chris Smith (R-N.J.) at a news event.

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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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Overall, medical ethicist Arthur Caplan, PhD, of the University of Pennsylvania sees the pill as a plus in terms of safety and access vs. surgery. "I think fighting over abortion technology is not the right battleground for fighting about abortion. ... You don't want to get to the point where, out of the attempt to achieve what you see as a moral goal, you put people at more risk," Caplan tells WebMD.

Mifeprex also might be the first of a wave of abortion drugs, but judging by the last decade, getting them approved will be a struggle.

Danco Laboratories has an exclusive license to market the drug under a license from the Population Council, the organization that holds the Mifeprex patent. The location of the manufacturing plant, where the drug will be made, remains a closely guarded secret.

Pagination