Pro-life groups are demanding that the Food and Drug Administration use a court-ordered Oct. 7 update to show real progress on its review of the dangerous abortion pill mifepristone, and to count the injuries women and their unborn children have already suffered.
John Mize, chief executive of Americans United for Life, said the agency has had more than a year and has shown the public little to indicate the review is underway.
“More than one year ago, HHS Secretary Kennedy and former FDA Commissioner Makary announced the safety review of the abortion pill, mifepristone, had officially started,” Mize said. “Since then, we have seen no public evidence this review has actually begun, much less any substantial progress made.”
Click here to sign up for pro-life news alerts from LifeNews.com
He said Wednesday’s filing will show where the agency’s priorities lie.
“The FDA’s response to the court will let the American people know where its priorities stand, whether with the women and children the review was initiated to protect or the political powers that continue to prolong the review until the dust of the coming midterms have cleared,” Mize said.
Mize said a durable review cannot rest on the agency’s own adverse-event system.
“In the update to the court, the FDA must show real progress using robust, real-world data,” he said. “Continuing to source data from their internal, flawed FDA Adverse Event Reporting System will not produce a durable review that accurately reflects the complications women face, as AUL has argued alongside pro-life doctors for months. The Pro-Life Movement is prepared to reject a methodologically flawed review where the agency has simply gone through the motions to rubber stamp the current REMS, or lack thereof.”
“Americans United for Life will continue to hold the FDA and greater administration accountable for their delays,” Mize said. “We recognize the confirmations of Attorney General Todd Blanche, CDC Director Erica Schwartz and the nomination of Dr. Heidi Overton to fill the role of FDA Commissioner as steps in the right direction, hoping for swift action to correct Biden-era mistakes following the review’s conclusion.”
Students for Life of America President Kristan Hawkins said any review that ignores abortion-pill pollution will fail.
“The number of things we don’t know about this alleged review of chemical abortion pill policy is concerning, especially considering the FDA’s Wild, Wild West of abortion they have set up since sloppily approving mifepristone in 2000,” Hawkins said. “A real review should have been a first 100 days effort by the Trump Administration along with enforcement of the Comstock Act. But at this point, any review that does not include dangers to the environment and endangered species from abortion water pollution will be an epic fail.”
Hawkins said both sides are watching the fine print.
“For almost 10 years, Students for Life has prioritized ending death-by-drugs, the abortion lobby’s favorite way to make a fast buck,” she said. “We want to see the kind of review that does not rest on abortion-industry studies and includes new dangers, such as abortion water pollution. The quality of the evidence will be key in whether or not the report will be effective.”
SBA Pro-Life America President Marjorie Dannenfelser said Monday that Overton committed in Senate testimony to conduct the study in “the most durable, scientific way possible,” echoing Secretary Kennedy’s pledge of research “grounded in Gold Standard Science and rigorous, transparent, and objective evidence.” She said a rigorous study must include commercially available data released in April 2025 by the Ethics and Public Policy Center and the Restoration of America Foundation, plus Medicaid data collected after the in-person dispensing requirement was removed.
An Ethics and Public Policy Center analysis of more than 865,000 insurance claims found a serious adverse-event rate closer to 11 percent, against the abortion industry’s claim of less than half a percent. That means tens if not hundreds of thousands of women have suffered abortion pill injuries.
Data filed in State of Louisiana v. FDA said a serious adverse event was “from 1.53 to 2.33 times as likely with remote dispensing as with in-person dispensing.”
EPPC President Ryan T. Anderson said the rate was 10.15 percent before the FDA dropped the in-person requirement and 11.5 percent after. The same filing found mifepristone was given to women with ectopic pregnancies “from three to six times as likely” without an in-person visit, and that more than 600 additional women with ectopic pregnancies were given the drug inappropriately after those visits stopped.
Dannenfelser said the administration should not wait for the study to finish.
“Given that the Biden administration relied on insufficient evidence and flawed assumptions in removing the in-person dispensing requirement, the FDA should restore that safeguard immediately,” she said. “And it can do so by settling its litigation against Louisiana.”
In May, Justice Samuel Alito issued an administrative stay that temporarily restored nationwide mail-order access to mifepristone, pausing a unanimous 5th U.S. Circuit Court of Appeals order that the in-person requirement be reinstated while the case proceeded.
The 5th Circuit said the FDA “conceded it had failed to adequately study whether remotely prescribing mifepristone is safe” and could not say when its review would be done. The appeals court wrote that every abortion facilitated by the FDA’s action “cancels Louisiana’s ban on medical abortions” and undermines the state’s policy that “every unborn child is human being from the moment of conception and is, therefore, a legal person.”
An August report led by Sen. Bill Cassidy, R-La., said abortion-pill companies have left mothers at risk.
“Abortion drug companies are putting mothers at risk through their failure to properly oversee the prescription and distribution of their products,” Cassidy said. “We are seeing that the explosion in online sales of chemical abortion drugs has opened the door to coercion and abuse of women.” The report concluded that “more stringent oversight mechanisms are needed, beginning with the reinstatement of the in-person dispensing requirement.”
