FDA's Move on New Drug Adds Fuel to Abortion Fire
WASHINGTON — The French abortion pill, RU-486, is one step closer to legalization in the United States - and both sides in the abortion battle are gearing up for an escalation in the political war over this drug.
A recommendation Friday by a panel of the US Food and Drug Administration for final approval of RU-486 - known in this country as mifepristone - makes its legalization in this country likely. FDA Commissioner David Kessler says the agency aims for final approval by mid-September.
Abortion-rights supporters hail the drug, not as a panacea, but as an important option for women who want to end a pregnancy without an invasive procedure. They hope that women will eventually be able to get abortion drugs from their private physicians, thereby avoiding abortion clinics which are often the targets of harassment and violence.
But abortion foes charge that the FDA is speeding approval of mifepristone for political reasons, jeopardizing women's health and increasing the number of abortions.
The immediate impact of the FDA panel's recommendation might soon be felt on Capitol Hill. Abortion foes may try to block legalization of mifepristone by attaching amendments to an FDA reform bill still pending in Congress.
"In committee or on the floor, there could be an amendment saying none of the funds in this bill may be used to implement or approve mifepristone," says Lisa Kaeser, a policy analyst in the Washington office of the Alan Guttmacher Institute, a reproductive health research organization.
The matter takes on heightened political significance in an election year where abortion has become a flashpoint of discord, particularly within the Republican Party. Blocking the abortion-pill is likely to become a priority of anti-abortion forces.
The FDA's task has been to assess the safety and effectiveness of mifepristone and its companion abortion drug, misoprostol, without regard to the philosophical questions underlying abortion. But beliefs about abortion, and the highly charged politics surrounding it, are inextricably linked. Abortion foes charge that most members of the FDA's reproductive health panel were predisposed to recommend approval of mifepristone because they favor abortion rights.
"We can't overlook the fact that [the FDA] is a government body, and that this president is committed to getting RU-486 approved and in use in the US," says Olivia Gans, a spokeswoman for the National Right to Life Committee. "It's about the only promise he's not broken."
Ms. Gans asserts that the US clinical trials of mifepristone, which started less than two years ago, are inadequate to test the drug's effects. The FDA panel considered not only the US trials but also data from France, where the drug has been in use since 1988. But Gans argues that because the US is more ethnically diverse than France, French data are insufficient for judging the drug in the US. She also argues that because the US doesn't have universal health care, Americans are less apt to go to doctors.
This matters because a mifepristone abortion requires several visits to a doctor and administration of a second drug, misoprostol, if the first drug does not induce miscarriage. Most women who have tried it report unpleasant side effects. In rare cases, a blood transfusion has been administered.
Mifepristone is not a "morning-after pill." It can be used up to seven weeks of pregnancy, but not until a woman has missed a menstrual period. And because of the need for several followup visits to a doctor, the price is roughly the same as a surgical abortion.
Usage in both France and the US shows mifepristone induces abortion more than 95 percent of the time. In the remaining cases, a woman has a surgical abortion to complete the process. For this reason, mifepristone will initially be distributed in abortion clinics if approved. Doctors at these clinics are the most accustomed to handling pregnancy terminations.
But it is too soon to say how many physicians would eventually be willing to administer mifepristone abortions. Last year, a survey of 138 Iowa doctors in small communities found that while most do not perform surgical abortions, one-fourth would consider doing mifepristone abortions. For abortion-rights supporters, the lack of availability of abortion in rural areas is a major concern.
Operation Rescue, a Dallas-based group that blockades abortion clinics, vows to target doctors who prescribe mifepristone. "We'll find out who's doing it, because women will call us and let us know," says Rhonda Mackey, the group's spokeswoman. "I think RU-486 will do itself in."
Kathryn Kolbert, a lawyer who has argued for abortion rights, says gaining widespread use of mifepristone won't be easy. But, she adds, "I'm confident that with enough focused public support - with people contacting their members of Congress - we can win that fight."