National NOW Times >> Winter, 2001 >> Article
FDA Approval of Mifepristone
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
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
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
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
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
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.