National Abortion and Reproductive Rights Action League

The drug mifepristone, commonly known as RU-486, was approved in September 2000 for use in early nonsurgical abortions. In the following viewpoint, the National Abortion and Reproductive Rights League (NARAL) reports that mifepristone is a safe and effective method of abortion. The side effects of RU-486 are not unduly debilitating, and medical complications are rare, NARAL maintains. Many women actually prefer an RU-486 abortion to a surgical abortion because it is a private and noninvasive medical procedure. NARAL, based in Washington, D.C., works to maintain the right of all women to have legal abortions.

As you read, consider the following questions:

1. According to NARAL, how long has mifepristone been in use"
2. For what reason have anti-choice forces attempted to deny access to nonsurgical abortions, in the authors’ opinion?
3. According to a study cited by NARAL, what percentage of women who have used RU-486 would recommend it to others"

Opposition to the right to choose abortion has impaired medical advances and scientific research in the United States. Use of mifepristone (formerly known as RU 486) in combination with a prostaglandin is an early option for effective, nonsurgical abortion and has been used since 1981. Mifepristone was approved for use in China, France, Great Britain, and Sweden following extensive clinical trials that demonstrated its safety and effectiveness. In addition, in 1999, Austria, Belgium, Denmark, Finland, Germany, Greece, Israel, the Netherlands, and Spain approved mifepristone. Recognizing that mifepristone would expand women’s choices and make it more difficult to target abortion clinics for violence and harassment, anti- choice forces have worked to deny women access to nonsurgical methods of abortion.

The Fight for Approval of Mifepristone

During the George Bush Administration, the U.S. Food and Drug Administration (FDA) issued an “import alert” which helped ensure that mifepristone would not be available in the United States for any purpose. A U.S. District Court that examined the “import alert” concluded, “[T]he decision to ban the drug was based not from any bona fide concern for the safety of users of the drug, but on political considerations having no place in FDA decisions on health and safety.”

In January 1993, President Bill Clinton signed an Executive Order directing the Department of Health and Human Services to assess initiatives to promote the testing and licensing of mifepristone. From 1994–1995, the Population Council conducted clinical trials on mifepristone in the United States. In 1996, the FDA Advisory Committee for Reproductive Health Drugs recommended approval of mifepristone as a safe and effective nonsurgical method of abortion. In September 1996 and again in February 2000, the FDA issued “approvable letters” for the drug, one of the last procedural steps before final approval. On September 28, 2000, the FDA finally approved mifepristone, for use in combination with misoprostol, as an early option for nonsurgical abortion.

• Over 620,000 women have safely used mifepristone as an early option for nonsurgical abortion in Europe.

• U.S. clinical trials tested a mifepristone/misoprostol combination that has been used safely and successfully in Europe. The U.S. clinical trials involved 2,100 women across America. The New England Journal of Medicine reported in 1998 that a regimen of mifepristone and misoprostol was successful in medically terminating a pregnancy of 49 or fewer days duration in 92 percent of cases, and that the regimen was safe, with side effects consisting of heavy bleeding, cramping, and nausea.

• In France, where mifepristone is administered up to seven weeks from the start of the last menstrual period, 87 percent of women have complete abortions within three days. Within approximately two weeks, 97 percent of women who receive the drug combination have complete abortions. The rates were somewhat lower in the U.S. clinical trials, but the study’s authors suggest that the 92 percent success rate may be due to lack of provider experience with nonsurgical abortion in the United States as well as to the rigorous design of the study.

• Another recent study based on these clinical trials reports very high patient satisfaction with the regimen: 95.7 percent of women who have used mifepristone would recommend the method to others, and 91.2 percent would choose it again if necessary.

•The process for using mifepristone begins with counseling, a physical examination, and a determination of the length of the pregnancy. At the first visit an initial dose of mifepristone is taken orally. Two days later, a prostaglandin called misoprostol is administered orally or in suppository form. A final visit, approximately twelve days later, verifies that the abortion is complete. If it is not complete, traditional surgical abortion is strongly recommended.

Why Women May Prefer the Abortion Pill

•Women might prefer to use mifepristone over traditional, surgical abortion for a variety of reasons, including that it does not require an invasive procedure or surgery, requires no anesthesia, and does not carry the risk of uterine perforation or injury to the cervix. In addition, many women feel it gives them greater control over the process and increases their privacy. A recent study found that women perceive nonsurgical abortion as a “natural” method—women who choose nonsurgical abortion place importance on the method’s resemblance to “a natural miscarriage” and the fact that the abortion can occur at home.

• If the mifepristone/prostaglandin regimen became widely available internationally, it could reduce the estimated 20 million unsafe abortions occurring annually worldwide by giving women an alternative to surgical abortions conducted under dangerously unhygenic conditions. . . . Anti-Choice Efforts

These significant gains [have been] threatened by the anti- choice majorities in the United States House and Senate. In 1998 and again in 1999, the House adopted an amendment offered by Oklahoma Republican Representative Tom Coburn to bar the FDA from expending any funds to test, develop, or approve drugs that could cause an abortion, such as mifepristone. They cite no precedent for Congress inserting itself into the scientific decision-making process of the FDA to deny Americans access to a safe and effective drug. Although the provision was not enacted, anti-choice forces will likely renew such efforts to reverse the approval of mifepristone.