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National NOW Times >> Winter, 2001 >> Article

FDA Approval of Mifepristone Immediately Targeted

By Alicia Wallace

On Sept. 29, 2000, the Food and Drug Administration (FDA) announced its approval of mifepristone. previously known as RU-486, and now by its new trade name Mifeprex. in the United States. Twelve years in the making, the FDA's decision is hailed by abortion rights activists as the next stage in reproductive health options in this country. Although the approval is acclaimed for its potential to increase access to abortion services and options, the celebration is cautious as reproductive rights opponents vow to limit use and distribution of mifepristone.

"The long-awaited availability of mifepristone in the U.S. means fewer women may have to face a gauntlet of clinic protestors and more physicians may be available to offer care," said NOW Executive Vice President Kim Gandy. "However, if anti- abortion rights forces. through litigation, legislation or other attacks. manage to force public disclosure of the names of physicians who prescribe mifepristone, this important advantage of the drug will be lost."

Mifepristone has been commercially available in countries outside the U.S. for many years. It has been used by more than half a million European women, and many more in Asia. Mifepristone has proven safe and effective in terminating pregnancy without invasive surgery. In the U.S. it has been the subject of political debate unlike any other new drug. For years, anti-abortion rights activists and legislators have pressured the FDA to require extensive testing, impose unnecessary restrictions or withhold the drug altogether.

The drug requires three separate physician visits, as mandated by the FDA. The first two visits are to administer mifepristone (to block hormones essential to pregnancy) and misoprostol (to induce miscarriage). The third visit is to assure that the process is complete. This has been found to be 97 percent effective in terminating pregnancy, and of the women who took part in the test trials, 96 percent said they would recommend the method to other women.
Mifepristone has other potential health benefits that rarely make it into public discourse on the drug. It has already proved useful in treating Cushing's Syndrome, some types of breast cancer and endometrial cancer. It may also help treat ovarian cancer, infertility, endometriosis, certain types of tumors, AIDS, glaucoma, and Alzheimer's.

Immediately upon approval, anti-abortion-rights lobbyists and congress members sought to limit distribution and use of mifepristone under the guise of protecting women's health and safety. On Oct. 6, Rep. Tom Coburn, R-Okla., and Sen. Tim Hutchinson, R-Ark., introduced legislation in the House and the Senate to reduce availability of Mifeprex to U.S. women. The proposed restrictions would limit prescription privileges to doctors who currently perform abortions, are credentialed to perform ultrasound procedures, have completed a government-approved program regarding Mifeprex, and more. The legislation also includes restrictions already placed on the drug by the FDA.

Women's rights advocates point out that an FDA decision has never before been questioned in such a manner and that the agency's review process is one of the strictest in the world. The FDA has approved 557 new drugs since 1995, without Congress imposing such strict distribution requirements on any drug, let alone one proven as safe and effective as mifepristone.

Additional legal restrictions would negate many of the advantages of Mifeprex, making it as difficult to find as traditional abortion services. already unavailable in 86 percent of U.S. counties. Restrictions would also subject women who use the drug to the harassment, clinic bombings, and other terrorist attacks that plague abortion providers.

At the state level, anti-abortion rights legislators have been quick to argue that mifepristone is fully bound by existing abortion restrictions, such as parental notification and consent laws for minors, and mandatory delays, which are in effect in 31 states. They, like conservative members of Congress, are also seeking new laws specifically to block Mifeprex.
"Reproductive rights supporters must keep a close watch on state and federal legislators in order to respond quickly and decisively to attempts to restrict access to medical as well as surgical abortions," said Gandy.

Keep up-to-date on legislative action and sign up to receive e-mail action alerts through NOW's web site at www.now.org/issues/legislat/. NOW also encourages you to contact your state and federal representatives and urge them not to interfere with women's use of mifepristone.

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