Statement on the FDA’s Mifepristone Study Update
For Immediate Release: Oct 7, 2026
Contact: [email protected] | View Newsroom
Washington, D.C. – In response to the U.S. Food and Drug Administration’s court-ordered update on its abortion drug study, SBA Pro-Life America President Marjorie Dannenfelser issued the following statement:
“The FDA’s court-ordered update on its abortion-drug study is alarming. Twenty months after first promising this review, administration officials continue to describe it as, in Secretary Kennedy’s words, ‘grounded in gold-standard science.’ FDA nominee Dr. Heidi Overton echoed that claim last week, testifying that the study is being conducted in ‘the most durable, scientific way possible.’
“But instead of the promised gold-standard study, the FDA is trying to peddle fool’s gold. There is no indication that the agency has obtained commercially available data. And it remains unclear whether the FDA will even analyze crucial Medicaid data that reflect the 2023 changes to the abortion-drug regimen given Sentinel 2.0’s limitations.
“The administration must correct course – and, more importantly, it must not wait for the study to conclude before acting. Peer-reviewed evidence shows that the Biden administration relied on insufficient evidence and flawed assumptions when it removed the in-person dispensing requirement. Even HHS Secretary Kennedy and former FDA commissioner Makary have admitted that the agency’s safety analysis was inadequate.
“The Trump administration must restore the vital safeguard of in-person dispensing immediately by settling the federal government’s litigation against Louisiana.
“Even under the FDA’s current timeline, the study will not be completed for at least another six months. Without action, that means 90,000 additional abortions in states whose strong protections for unborn children are being circumvented by the mail-order abortion-drug policy. It also means more women left vulnerable to coercion and abuse because basic medical oversight is absent, denying women the healthcare they deserve and instead empowering abusers. Action is long overdue.”
This week, the Charlotte Lozier Institute released peer-reviewed research showing the FDA lacked evidence to remove the in-person dispensing requirement for mifepristone in 2021. The agency relied on inadequate adverse event reporting and studies lacking real-world conditions in which abortion drugs are used, according to the research. The FDA cited or relied on letters, clinical guidance, and other input from groups with financial or political incentives to support a weakened REMS during the review.
Susan B. Anthony Pro-Life America is a network of more than one million pro-life Americans nationwide, dedicated to ending abortion by electing national leaders and advocating for laws that save lives, with a special calling to promote pro-life women leaders.
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