Politics Over Medicine?

What's the Hang Up with RU-486?

by Lourdes Rivera, National Health Law Program
The National Women's Health Network provided extensive input into this article.
August 2000

The status of the drug mifepristone (previously known as RU-486) has been in the news recently. Mifepristone is a drug that would allow women in the United States to have an early abortion, just like European women have had for more than 10 years. At issue is when and how the Food and Drug Administration (FDA) will approve this product which the FDA has already determined to be a safe and effective option for early abortion. The drug has been available to some women in the U.S. since 1994 through clinical trials, but the FDA approval would mark its official entry into the U.S. market and would expand access to women who do not live near trial sites.

Mifepristone is an antiprogestin which, when used in combination with the prostaglandin drug misoprostol, can cause an abortion. It has been found to be about 95 % effective when used within 49 days of the beginning of a woman's last menstrual period. Mifepristone abortions have been available in France since the drug was approved there in 1998. In the time since, China and 10 additional European countries have approved the drug for marketing.

Early options for abortion have been slowly expanding in the United States in the last few years, but mifepristone represents the first drug that would be approved by the FDA for this use. According to a recent article in the August 14, 2000 issue of the Los Angeles Times, more doctors would offer abortions if they could do so with an FDA-approved pill in the privacy of their offices. Providing doctors with a means to offer this service in their offices can help increase access dramatically. This is important to address the problem of diminishing access – the Alan Guttmacher Institute reports that 86 % of U.S. counties lack abortion providers and the number of abortion providers decreased by 14% between 1992 and 1996.

Given mifepristone's rapid approval in other countries, its absence seems notable in the U.S., where women have been calling for access since it was first made available in France. First, the French company that owned the rights to the drug simply refused to bring it to the United States, citing the Bush Administration's lack of support of abortion rights. In 1994, after several years of stonewalling, the French company gave the U.S. rights to mifepristone to the Population Council, a non-profit research group, at the urging of the former FDA Commissioner, Dr. David Kessler.

Since then, the Population Council has conducted a clinical trial of mifepristone in the United States and looked for a company to serve as its U.S. distributor. In spite of public opinion polls showing strong support for both early abortion generally and mifepristone specifically, no existing pharmaceutical company was willing to take on U.S. distribution of the drug. The Danco Group, of New York City, was created for this purpose.

In 1996, after reviewing the clinical trial data, the FDA issued a statement that mifepristone was safe and effective for use in abortion. The only remaining hurdle for U.S. approval of the drug was for the agency to review labeling and manufacturing information. The Danco Group provided this information to the FDA and expected to receive approval by the end of 1999 or the beginning of 2000.

In an unexpected turn of events, the FDA issued another list of questions and demands before it would give the drug final approval. The FDA is proposing very tight restrictions for distribution that would severely limit mifepristone's availability. The restrictions would require that only physicians can disperse the drug (to the exclusion of other qualified providers) and that those physicians who do so must be trained to perform surgical abortions. In addition, the FDA would require that physicians dispersing the drug be trained in operating ultra-sound equipment and have admitting privileges at a hospital within one hour of their practice. Moreover, physicians would have to be "certified." All of these restrictions would undermine physicians' willingness to prescribe the drug, in particular the certification requirement which would involve having physicians' names on a list, making them vulnerable to harassment and violence.

Groups, such as the National Women's Health Network, and many medical and scientific experts who are familiar with the extensive record of safe and effective use of mifepristone believe that these restrictions are unnecessary and unprecedented for any drug with a similar safety record. They believe that because the restrictions would limit access to mifepristone, the restrictions would be harmful to women's health.

Negotiations are continuing with the FDA. However, the agency is running out of time to approve the drug. The Los Angeles Times reported that the FDA has a self-imposed deadline of September 30, 2000 to make a decision. While the agency can extend the deadline, a delay until after November (depending on the election results) diminishes hope that women will have access to a safe and effective method of early abortion.

See also, Shari Roan, The Abortion Pill: Finally at Hand? Los Angeles Times (Special Health Section, Aug. 14, 2000).