Marking a victory for abortion rights supporters after more than a decade of political controversy and delays, the Food and Drug Administration on Thursday approved the abortion pill known as RU-486 as a non-surgical alternative for early-term abortions.
The drug, also called mifepristone, could increase women’s access to abortion services by appealing to doctors who otherwise would not perform abortions, some experts said. Officials at the National Abortion Federation, an association of abortion providers, said they hope to make the pill available to doctors in about a month.
Regulations published Thursday permit use of mifepristone only within 49 days after the start of a woman’s last menstrual period. The rules also stipulate that the drug be administered in the office of a qualified doctor, in part to monitor side effects that sometimes include heavy bleeding.
“For those who choose to have an early termination of their pregnancy, this is a reasonable medical alternative,” FDA Commissioner Jane Henney said. “The decision was not difficult to make when you look at the science.”
Yet supporters and opponents of abortion rights have clashed over mifepristone repeatedly for more than a decade–a conflict that was already reverberating Thursday in the presidential campaign.
The presidential candidates have opposing positions on mifepristone. Texas Gov. George W. Bush, whose father banned the import of mifepristone in 1989 when he was president, opposed its approval by the FDA on the grounds that the drug would make a morally questionable procedure more easily available.
One of President Clinton’s first acts in office was to order the FDA to begin re-evaluating mifepristone. Vice President Al Gore on Thursday supported the FDA’s action in approving the abortion drug.
“Today’s decision is not about politics, but the health and safety of American women and a woman’s fundamental right to choose,” said Gore, the Democratic nominee.
Earlier this week, Gore told a group of college students at a televised forum sponsored by MTV that political concerns should not keep the drug off the market.
Bush called the decision to approve mifepristone “wrong.”
“I fear that making this abortion pill widespread will make abortions more and more common, rather than more and more rare,” the Republican nominee said. “As president, I will work to build a culture that respects life.”
Despite fears that mifepristone could increase the overall number of abortions, supporters of the FDA’s action noted that no such rise has occurred in France since that country became the first to approve the drug in the late 1980s. Rather, the proportion of abortions in France that are drug-induced has risen.
The drug also has been approved in Sweden, Britain, Israel, China and nine other European countries. Experts estimate that millions of women worldwide have used it.
Officials with the Bush campaign declined to comment specifically on whether Bush would try to reverse the FDA’s decision if elected.
But when asked during a Republican primary debate in January what his reaction to FDA approval would be, Bush said: “I’d be inclined not to accept that ruling.”
Many groups and politicians opposed to abortion reacted bitterly to Thursday’s ruling, while groups that support abortion rights were jubilant.
“We’re thrilled,” said Eleanor Smeal, president of the Feminist Majority Foundation. “We think it’s a big victory for women, and for the women’s movement.”
That victory “has been far too long in coming to American women,” said Kate Michelman, head of the National Abortion and Reproductive Rights Action League.
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The Catholic Archdiocese of Chicago condemned the decision.
“Today, the legacy of our government’s rejection of fundamental human dignity is again made clear in the FDA’s decision to sanction a new method of killing our offspring,” said Nora O’Callaghan, director of the archdiocese’s Respect Life Office.
One effect of the abortion pill’s availability may be to increase the number of abortions undertaken at an early stage of pregnancy, when few defining human characteristics are visible and public support for the abortion option is strongest.
Experts said the drug typically would be used no later than the fifth week after fertilization.
At that point, a human embryo is approximately the size of a grain of rice. The embryo’s nervous system consists of a neural tube that will develop into the brain and spinal cord.
Mifepristone works by preventing a fertilized egg from attaching to a woman’s uterine lining. Even if the drug is administered after the fertilized egg attaches, it causes the uterine lining to reject the embryo.
A woman seeking an abortion with mifepristone will have to go to a doctor’s office to take the first three pills, according to the FDA. Two days after that, the woman must return to get a second drug called misoprostol, which causes uterine contractions and induces miscarriage of the embryo.
Most patients have a spontaneous abortion within 24 hours of taking the second set of pills. FDA regulations call for women to return after two weeks to verify that the embryo has been aborted.
In clinical trials in France and the U.S., mifepristone caused abortions with no serious complications in 92 percent to 95 percent of women. The remaining patients needed a surgical procedure to complete the abortion.
In addition to bleeding, the drug’s side effects include cramps, nausea, headaches, vomiting and diarrhea. About 2 percent of patients had bleeding severe enough to require surgical intervention.
“It’s a medical therapy that absolutely requires skilled surgical backup,” said Dr. David Cohen, a reproductive endocrinologist at the University of Chicago.
Some anti-abortion groups count mifepristone’s risks as one reason for their opposition to the drug.
“The Clinton-Gore administration, which claimed it wanted to make abortion rare, has embraced an abortion pill that will result in more abortions and new risks to women,” said Laura Echevarria, a spokeswoman for the National Right to Life Committee.
Despite the risks, experts said drug-induced abortions generally are less dangerous than surgical abortions, which carry the risk of infection. And childbirth itself always brings a danger of complications.
In fact, the advantages of mifepristone make it ethically preferable in some ways to surgical abortions, said Arthur Caplan, director of the center for bioethics at the University of Pennsylvania.
“I think ethically this has long been overdue,” Caplan said. “It’s hard to imagine that a procedure that puts a woman less at risk, and that’s done earlier than surgical abortion, is not morally defensible. If you don’t believe that life begins at conception, if you believe–as the Supreme Court does–that the moral status of the fetus evolves, then earlier is better.”
One disqualifying factor for women who want to take the drug is an ectopic pregnancy, in which the embryo implants in the mother’s fallopian tubes. Mifepristone usually will not abort an ectopic pregnancy. Such pregnancies can be dangerous if untreated, especially if the tubes rupture.
The FDA requires that doctors who administer mifepristone be qualified to diagnose an ectopic pregnancy.
Yet the rules published Thursday are less restrictive than some experts had expected. Some abortion rights groups feared that the FDA might limit prescribing privileges to doctors who also perform surgical abortions.
“It’s a key point,” said Alice Dan, director of the Center of Excellence in Women’s Health at the University of Illinois at Chicago. “More accessibility means that women will be more likely to arrange an abortion as soon as they make the decision, as opposed to having to wait to travel to a large city.”
The FDA’s rules include a letter for physicians describing the necessary qualifications for administering the drug. Doctors must sign the letter and return it to the drug’s distributor before they can establish an account and receive the pills.
The U.S. license for mifepristone is held by the Population Council, a group that supports family-planning efforts around the world. Marketing and distribution will fall to New York-based Danco Laboratories LLC.
Although mifepristone is now the abortion drug’s chemical name, it was first named RU-486 after Roussel Uclaf, the French company that discovered it. The drug will be sold in the U.S. under the brand name Mifeprex. Analysts estimate the treatment will cost about $300, similar to the price of surgical abortions.
In anticipation of the FDA action, the National Abortion Federation has trained more than 1,800 health-care clinicians in the use of the drug. Two-thirds of its members, or 240 abortion providers, have said they would offer drug-induced abortion if the FDA approved it. The federation’s toll-free hot line will provide referrals, and the group has added extra operators.
“We expect to be inundated with phone calls,” said Vicki Saporta, the group’s executive director.
But a major promise of mifepristone has been the expansion of abortion services beyond those doctors who now perform surgical abortions. The number of abortion providers in the U.S. has been shrinking since 1982, from a high of 2,908 that year to 2,042 in 1996, according to the Alan Guttmacher Institute.
In Illinois, the number of providers shrank in the same period from 58 to 38.
A Kaiser Family Foundation survey found that one-third of obstetrician/gynecologists who do not currently perform abortions said they would prescribe RU-486 abortions if the FDA approved it. The Wall Street Journal has reported that Danco, the drug’s marketer, projects that mifepristone may account for 29 percent of U.S. abortions after four years on the market.
Little noted in the abortion controversy are the applications of mifepristone for treating some types of cancer–uses that some experts hope will be advanced by Thursday’s ruling. The drug has been shown to decrease the size of benign tumors of the uterus, and has been effective in treating some kinds of breast cancer.
Supporters and opponents of the FDA’s decision made heartfelt vows Thursday to keep fighting on the issue.
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“This is a sad day for America,” said Rep. J.C. Watts (R-Okla.). “A new administration, I am certain, with moral leadership and a commitment to the family will reverse this Clinton-Gore decision.”
Michelman of NARAL said the possibility that Bush would seek to overturn the FDA’s approval is one reason she will keep stumping for Al Gore. But she took a moment Thursday to savor the victory.
“It’s been a long journey,” Michelman said. “It’s an emotional day.”