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.