RU-486 Approval Pits Science Against Politics
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.
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.