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The Abortion Pill: Finally At Hand?

Although it has been used in Europe for a decade, its U.S. approval has been mired in bureaucratic and production delays as a crucial federal deadline approaches.


his was to have been the year that would change abortion in America.

With the anticipated arrival of the abortion pill, mifepristone, or RU-486, American women were to have gained an alternative to surgical abortion that, most health experts believe, would make abortion safer, more accessible and more private.

But this is the United States, and nothing about abortion is predictable.

After a decade of use by women in France, England and many other countries and after approximately 500,000 abortions worldwide, mifepristone is still not available in this country. Instead, RU-486 has encountered a daunting obstacle course strewn with antiabortion politics, bureaucratic red tape and missteps by the abortion rights group that is shepherding efforts to get the drug on the U.S. market.

Now, as a crucial Sept. 30 federal deadline nears, the fate of the abortion pill remains uncertain. Abortion rights advocates fear that the Food and Drug Administration may delay approving the drug or so severely restrict it that women and their doctors will be reluctant to use it as an alternative to surgical abortion.

(The FDA earlier this year set Sept. 30 as its deadline for deciding whether to approve mifepristone. The agency could also decide to set a new deadline.)

"I don't think the public understands that because of politics, we are falling way behind other countries in terms of access to medical abortion," says Francine Coeytaux, co-founder of the Pacific Institute for Women's Health in Los Angeles.

Coeytaux and other abortion-rights supporters say that a window of opportunity for approving mifepristone may be slipping away, especially if the Republicans take control of the White House next year. Mifepristone, used to terminate pregnancy, differs from the "morning-after" pill, which is used within days of unprotected intercourse to prevent pregnancy.

Though Al Gore supports abortion rights and opposes restricted access to abortion, George W. Bush would allow abortion only in cases of rape, incest or to save the life of the mother. Bush's father, former President George Bush, banned importation of RU-486 in the late 1980s.

Abortion rights supporters fear that if the FDA fails to act in September and Bush wins in November, the drug may never be available in this country.

"It's clear that mifepristone would increase access to abortion," something that Republicans have traditionally opposed, says Marie Harvey, an associate professor of public health at the University of Oregon and a researcher on reproductive health issues.

Access has been a hot-button issue for both sides of the abortion debate. Throughout the 1980s and '90s, legislatures across the country passed laws that required parental consent for minors seeking abortions, mandatory counseling and waiting periods and other limitations. An estimated 86% of U.S. counties, the majority of them rural areas, lack abortion providers, and the number of abortion providers fell 14% from 1992 to 1996, according to surveys from the Alan Guttmacher Institute, a New York-based reproductive rights group.

About 49% of pregnancies among U.S. women are unintended, and about half of those--an estimated 1.37 million per year--are terminated by abortion, according to the institute.

An abortion pill, many reproductive health experts believe, would increase access because many doctors who don't perform surgical abortion would be more likely to offer the pill because it is relatively simple to use and could be given in the privacy of doctors' offices.

Taken early in a pregnancy, the abortion pill is expected to be less costly and less traumatic for a woman than surgical abortion, says Dr. Bryna Harwood, a reproductive health researcher at USC. "For many, many women in this country," she says, "access is a real problem."

Two-Drug Regimen Early in Pregnancy

Mifepristone, which is the chemical name for the French medication, is prescribed during the first seven weeks of pregnancy as part of a two-drug regimen. (The second drug used to trigger the abortion is misoprostol, already available for the prevention of ulcers.) Women undergoing a mifepristone abortion typically experience severe cramping, bleeding and nausea. However, the most serious potential side effect, heavy bleeding, is rare, researchers say. About one to three women per 1,000 required a blood transfusion, according to data from clinical trials of the drug in the United States.

In contrast, surgical abortion is typically performed no earlier than six weeks into pregnancy, requires anesthesia and carries risks, such as infection, associated with any surgery.

Mifepristone was developed in 1980 by the French pharmaceutical company Roussel Uclaf. France approved the pill in 1988, followed by England, Sweden, China, Israel, Russia, Spain and other countries.

In Europe, more than half of women who have a choice between RU-486 (sometimes called a medical abortion) and surgical abortion opt for the abortion pill, according to a 1996 survey.

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