Activists Brace for FDA's Decision on Abortion Pill
WebMD News Archive
Sept. 25, 2000 (Washington) -- It has been used by more than 500,000 European women. Even China has a generic version. But there is a chance that the highly controversial abortion pill RU-486 may never see the light of day in the U.S.
After four years of delays, U.S. health officials are expected Wednesday or Thursday to approve the highly controversial abortion drug. If that happens, the approval would mark the end of a decade-long struggle by pro-choice forces to market RU-486. But political concerns once again threaten to interfere with that regulatory process and, in effect, at least limit Americans' access to the politically charged morning-after pill.
The road for RU-486 in the U.S. has been bumpy, to say the least. In 1989, the FDA imposed an import ban on RU-486 when George Bush was in the Oval Office. And in 1993, President Clinton, after lifting the ban, ordered the Department of Health and Human Services to essentially accelerate its review of the abortion pill. Not to be left out, congressional Republicans have made two attempts at passing an amendment to the agricultural appropriations bill, forbidding the approval of RU-486.
Whether Democratic candidate Vice President Al Gore or Republican candidate Texas Gov. George W. Bush is elected president also might impact the fate of RU-486, says Wendy Chavkin, MD, MPH, a professor of public health at New York's Columbia University and recognized expert on reproductive issues.
"If George Bush gets elected, it would be a significant setback," Chavkin tells WebMD. For instance, should the FDA delay the decision past September, Bush, as president, could further stall the approval process through his selection of an FDA commissioner and secretary of Health and Human Services (HHS), Chavkin explains.
"Who is elected will have consequences," agrees Heather Cirmo, a spokeswoman for Family Research Council, a conservative anti-abortion rights group that has helped lead the fight against the approval of RU-486. If Bush is elected, anti-abortion rights forces might even be able to reverse the tables on a favorable FDA decision, Cirmo says. "We would support, encourage him to overturn the approval," she tells WebMD.
But a more likely consequence probably will be the passage of rules limiting the use and distribution of RU-486. In June, the FDA confirmed that it was considering a set of restrictions that would -- among other things -- require physicians prescribing the drug to have admitting privileges in hospitals and be able to conduct a surgical abortion.
If passed, the rules effectively would stifle one of the most promising benefits to this drug, Chavkin tells WebMD. As is, RU-486 offers the opportunity for women to avoid harassment and violence because the abortion can be done in the doctor's office rather than an abortion clinic, Chavkin explains. But if the restrictions are passed, many health care providers will not be able to offer the drug -- especially in rural areas where access to hospitals is limited -- or to prescribe the drug due to their lack of experience with surgical abortions, she says.