For Immediate Release
April 12, 2023
Abortion Drug is Not "Safe and Effective"
FDA’s removal of safety precautions on mifepristone violates original approval standards
Washington, D.C. – On Friday, April 7, Texas Judge Matthew Kacsmaryk blocked the Food & Drug Administration’s (FDA) approval of the abortion drug Mifepristone because of the FDA’s removal of safety precautions and medical protocols, making it less safe and dangerous for women to take and undermining its legal obligation to protect women’s health, safety, and welfare.
Mifepristone is used to terminate a pregnancy up to ten weeks, but the lack of medical oversight and access to emergency medical assistance can be fatal to young women taking it alone and late in pregnancy. This drug blocks the mother’s natural production of “progesterone” for her child, cutting off blood and nourishment to the baby. The unborn child begins to starve to death. Between 24-48 hours later, the woman takes Misoprostol which causes the mother to contract and bleed to force the child out of the womb.
“Let’s be clear; there is nothing safe or effective about allowing people to perform their own DIY abortion,” said Penny Nance, CEO and President of Concerned Women for America, the nation’s largest public policy women’s organization. “Approval of this drug would allow anyone anywhere to have an abortion without any in-person medical supervision, reliable in-person safeguards and checks, and without a routine medical examination.”
“The medical community has had concerns over these drugs for years as the FDA cut corners, ignored safety concerns, fast-tracked, and politicized the process when they approved mifepristone.”
The plaintiffs in this case, including the Alliance for Hippocratic Medicine and other groups of doctors and national medical associations oppose the removal of safety precautions about this drug including that since 2021, it can be sent through the mail in clear violation of federal law.
“The FDA is not following its own standards and needs to answer for their reckless disregard for the women who take this drug,” continued Nance. “Young women taking an abortion pill alone in their room with no medical supervision and access to medical care if there are complications is not a ” ‘safe and effective’ drug but can be fatal.
“Americans who are concerned for the safety and well-being of young women should be grateful that this judge had the courage to make this decision. And Republicans who claim to be pro-life should be taking this issue head on and clearly articulating that protecting the lives of women is one of their highest priorities.”
Concerned Women for America Legislative Action Committee (CWALAC) is the legislation and advocacy arm of Concerned Women for America. Concerned Women for America is the nation’s largest public policy women’s organization with a rich 40-year history of helping our members across the country bring Biblical principles into all levels of public policy.