Abortion: Termination of Early Pregnancy with RU-486 (Mifepristone)

Publication Date: February 2001

Publisher: Library of Congress. Congressional Research Service

Author(s):

Research Area: Health

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Abstract:

On September 28, 2000, the Food and Drug Administration (FDA) approved the drug mifepristone, also known as RU-486, for the termination of early pregnancy. In 1988, France became the first country to approve the drug. China and the United Kingdom approved RU-486 in 1991, Sweden in 1992, and the following countries in 1999: Russia, Austria, Belgium, Denmark, Finland, Germany, Greece, Israel, the Netherlands, Spain, and Switzerland. Since 1988, more than 620,000 European women have used the drug to terminate pregnancy. Ten million abortions are performed annually in China, and about half are carried out with RU-486.

Because RU-486 is an abortion agent, the process of moving it out of the lab and into mainstream medicine has been fraught with controversy. Since its discovery, the pro-life movement has been adamantly against the use of this drug for abortion. In the United States, the drug's long journey to FDA approval began in 1983, when the agency agreed to clinical trials of RU-486 sponsored by the Population Council. After many difficulties in finding a manufacturer and distributor for the drug, final FDA approval was granted and the first U.S. orders for RU-486 were shipped on November 20, 2000.

The drug will not be available to women by prescription in pharmacies; instead women will receive it directly in a physician's office. Each woman must be given a Medication Guide which explains how to take the drug, who should avoid taking it and what complications may occur. A patient agreement similar to an informed consent document in a clinical trial must be signed. In contrast with surgical abortion, which is completed in minutes, drug induced abortion is more time consuming and uncomfortable. Treatment with RU-486 requires that the patient make three office visits over a 2-week period. Short-term risks associated with the drug are limited: about 1% of women require surgery to stop heavy bleeding and only 0.1% of women in clinical trials required a blood transfusion. To date, there is little evidence of any long term health effects due to use of RU-486.

Nevertheless, legislation introduced in the 107th Congress adds requirements for doctors dispensing RU-486 which, the sponsors state, would provide additional protection for women taking the drug. The bill stipulates that physicians prescribing the drug must meet the following requirements: (1) qualified to handle complications resulting from an incomplete abortion or tubal pregnancy; (2) trained to perform surgical abortions and met all applicable legal requirements to perform such abortions; (3) certified for ultrasound dating of pregnancy and detecting tubal pregnancy; (4) completed a program regarding the prescribing of such drug that uses a curriculum approved by the Secretary of the Department of Health and Human Services (HHS); and (5) have admitting privileges at a hospital located 1 hour or less away from the physician's medical office. In the opinion of pro-choice groups, this legislation represents an unprecedented intrusion into the jurisdiction of FDA and the practice of medicine. They point out that FDA reviewed all the scientific data reflecting the experiences of thousands of women and the agency rejected most of these requirements as medically unnecessary.