STATEMENT CONCERNING MIFEPRISTONE (RU-486)
July 19, 1996
Presented to the Advisory Committee for Reproductive Health Drugs
Food and Drug Administration, U.S. Department of Health and Human Services
by Jan Erickson, NOW Director of Government Relations and Public Policy.
Thank you for the opportunity to speak briefly at this historic meeting
of the Reproductive Health Drugs Advisory Committee. The National Organization
for Women, NOW, is the largest feminist organization in the country with
over 500,000 contributing members in 700 chapters in all states. We have
a long history of advocacy for keeping abortion safe and legal and accessible.
NOW believes that mifepristone should be found safe and effective by
this advisory committee and should ultimately be approved by the Food and
Drug Administration for general use in the United States. Sixteen years
of testing and clinical experience with mifepristone in Europe and America
has provided abundant evidence that the drug is effective in terminating
an early pregnancy, with very few side effects, none of which have been
serious. Mifepristone, in combination with prostaglandin, has been safely
and successfully used by nearly 200,000 European women. Approved by the
governments of France, Sweden and the United Kingdom, the RU-486 story
is one of sound medical technology responding effectively to meet vital
patient needs.
We are fortunate in the United States to benefit from the European experience.
It is our understanding that the U.S. clinical trial findings will be very
comparable to those from France, as regards safety and efficacy. We expect
that this advisory committee's conclusions will be based on a rigorous
examination of the available French and U.S. data and that the final decision
by the Food and Drug Administration will be based exclusively on strong
scientific evidence in favor of approval for mifepristone for general use.
Advances in the medical research in reproductive health have been tragically
slowed and even stopped in this country; women --and the general public--
have suffered immeasurably as a result. We must move forward. A majority
of the American public does not want to see safe and effective medical
improvements denied to anyone, private surveys show. And a substantial
proportion of abortion rights opponents, according to the same surveys,
are supportive of early medical abortions. A safe, effective early abortion
drug may begin to heal the wounding divide that has been created in the
public over this procedure.
The problem of accessibility to abortion services has been a vexing
one for reproductive rights advocates. Mifepristone offers the best solution
yet to expanding the pool of providers and, ultimately, to bringing the
cost of the treatment well within the means of most women. Mifepristone
also appears to address patient concerns about confidentiality, personal
safety, and freedom from harassment. The drug fits precisely in a regimen
critical to modern medical practice which values the confidential nature
of the patient-physician relationship. Additionally, as the acceptability
trials have shown, women find the use of mifepristone to be more "natural"
and thus, it could be reasoned, would more readily seek out the treatment
as soon as a crisis pregnancy is suspected.
Successful trials on mifepristone as a method for early abortion in
Vietnam, Cuba, China and India, by the Population Council, as well as trials
by the World Health Organization in Chile, Germany, Hungary, Singapore,
Hong Kong, the former Soviet Union and other parts of the world show that
there are no differences in rates of safety, efficacy, and acceptability
when comparing racial or ethnic groups. This would indicate that there
will be wide acceptance and use of this important drug worldwide.
As an organization concerned about the health of all women we are eager
to see this country move ahead. Such critical health problems as endometriosis,
breast cancer, and uterine fibroid condition, which affect millions of
women, could potentially benefit from further research on mifepristone.
Other conditions like Cushing's Syndrome, glaucoma, certain brain tumors,
AIDS, diabetes, Alzheimer's and Parkinson's disease await potential applications
to be found through mifepristone research. An aging American population
may be able to derive multiple benefits from this drug.
Finally, it should not be overlooked that mifepristone, through expanded
research and development in the United States, could make a tremendous
contribution to international contraception and fertility treatments --especially
in the developing world. That hundreds of thousands of women are still
dying each year in pregnancy and childbirth is something that should not
be tolerated by any nation. America's incomparable medical research infrastructure
and financial resources, coupled with the FDA's rigorous and independent
regulatory function, can help ensure for the world a safe and effective
drug through mifepristone.
Thank you.
NOW Foundation
733 15th Street, NW, 2nd Floor,
Washington, DC 20005 (202) 628-8669
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