NOW Members Call for FDA Approval of Mifepristone (RU-486) for Abortion, Cancer and Other Treatments

by Kristi Robles, Publications Intern

At NOW's National Conference this summer, members unanimously passed a resolution calling on "the President of the United States and Jane Henney, the Commissioner of the Food and Drug Administration (FDA), to expeditiously approve mifepristone (RU-486), without unnecessary restrictions that interfere with women's health care, the practice of medicine or life-saving scientific research."

The approval of mifepristone is under consideration by the FDA, along with a number of restrictions that would negate many of the drug's benefits. "It's all too typical that our U.S. bureaucracy would take this important medical advancement for women and make it as difficult as possible for us to take advantage of its full potential," said NOW's Executive Vice President Kim Gandy.

RU-486, often referred to in the U.S. by its medical name mifepristone, is an anti-progesterone drug that induces abortion by blocking essential hormones needed to maintain pregnancy. When administered early in the first term, followed by misoprostol, it provides a safe, effective and private alternative to surgical abortion. Mifepristone can also be used to treat Cushings Syndrome, menengiomas and other maladies. In combination with tamoxifen, mifepristone is a more effective treatment for certain breast cancers than tamoxifen alone.

RU-486 became available in France in 1988 after the French Minister of Heath declared the drug "the moral property of women," and ordered its owner, pharmaceutical company Roussel Uclaf, to bring it to market. Since then it has been authorized for use in 14 other countries and has been successfully administered to more than 500,000 women in Europe and many more in Asia. But despite its apparent effectiveness and overwhelming success, the U.S. has yet to approve mifepristone for public use. Why?

The initiation of RU-486's clinical trials in the U.S. over 10 years ago brought an onslaught of anti-abortion opposition to the drug. This opposition was so strong, in fact, that in 1989 the FDA succumbed to pressure from anti-abortion rights congress members and banned the import of RU-486 for personal use. The FDA's actions sparked a public education drive on RU-486 by NOW, the Feminist Majority Foundation and other reproductive rights supporters, and the struggle to bring mifepristone to the U.S. intensified.

Years of research, studies and testing have concluded that mifepristone is a reliable and safe method of early abortion. Two studies conducted by the New England Journal of Medicine concluded that mifepristone is a safe and effective post-coital contraceptive, which has fewer side effects and is easier to use than current morning-after pills, and that mifepristone, when administered with misoprostol, is 99 percent effective in terminating pregnancy during the first nine weeks. Though these compelling results were released nearly seven years ago and a letter that RU-486 is "approvable" was released by the FDA in 1996, the FDA has not sanctioned the use of the drug to this day.

By Sept. 30 of this year, however, the FDA is scheduled to issue its decision on mifepristone. While the debate on its effectiveness is almost over, feminists are still concerned about its approval and availability. Anti-abortion activists never stopped their pressure on the FDA, and with the possibility of mifepristone's September approval, they have restructured their fight. These right-wing forces, and their congressional allies who control FDA funding, in essence have coerced the FDA commissioners into considering restrictions on the drug's distribution, which could severely limit a woman's access to this non-invasive and more affordable option.

One of the most important advantages of mifepristone is that it can be utilized by a wider range of doctors than the surgical procedure and provides increased privacy for the women. The proposed restrictions, however, would halt the expansion of abortion providers by allowing only physicians who currently provide abortions to administer the drug. The restrictions also include a requirement of special training and certification for doctors dispensing the drug, which could result in their being publicly identified as abortion providers. This could make them vulnerable to anti-abortion violence and terrorism and is no doubt designed to discourage provider participation.

"By October 1, the fate of mifepristone approval should be decided," said Gandy. "But I am sure the fight for full access will continue, and NOW will not stop until all women have the right safely and privately to use mifepristone."