New drug application for ulipristal acetate as emergency contraceptive misleading, says Family Research Council

Family Research CouncilJun 17 2010

Tomorrow, the Food and Drug Administration (FDA) will hold a hearing to consider approval of a new drug application for an abortifacient drug, ulipristal acetate, as an emergency contraceptive, or a new "Plan B."

Jeanne Monahan, Family Research Council's Director for the Center for Human Dignity, released the following statement urging the FDA to reject the drug application:

"The drug manufacturer's application is very misleading because the chemical makeup of ulipristal is almost identical to mifepristone, popularly known as RU-486, which is primarily an abortifacient. While the drug can act in a way that inhibits ovulation, it also can act as an abortifacient.

"Women deserve to know the truth about drugs that are marketed to them, and the effects the drugs may have on their health and well-being. The FDA must seriously consider the adverse health effects the drug could have on women, in particular infection and severe bleeding as has been seen with RU-486.

"In the words of the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), 'Ulipristal acetate is an abortifacient of the same type as mifepristone (RU-486) and... its approval as an emergency contraceptive raises serious health and ethical issues. Furthermore, ulipristal's potential effects on women who used the drug off-label and upon ongoing pregnancies are essentially unexamined and untested.'

"Both ulipristal and mifepristone block the key early pregnancy hormone, progesterone, from functioning properly which effectively starves the embryo. That action potentially can interfere with or end an established pregnancy.

"Women deserve to know what the drug is doing in their body. Preventing human life from beginning is not the same as destroying a life that has already begun. And to many women it is a distinction that makes all the difference.

"We urge the FDA to take seriously its role to protect innocent human life and safeguard the health of American women by rejecting this abortion drug. We also urge a thorough review process to ensure that women's health is not jeopardized just to advance the agenda of the abortion industry."