Dr. Christina Francis, CEO of the American Association of Pro-Life Obstetricians and Gynecologists, has raised concerns about the FDA's reliance on insurance claims data from its Sentinel System, a national electronic infrastructure that allows the agency to monitor the real-world safety of approved medical products using electronic health care data.
She warns that incomplete insurance claims data could underestimate mifepristone's complications because the records may not capture all abortions, emergency room visits or subsequent medical treatment, potentially leaving serious adverse events undercounted and giving regulators an incomplete picture of the drug's safety.
She says the data set lacks Medicaid records after 2021, the year the FDA lifted in-person dispensing requirements, allowing the drug to be delivered by mail.
"It's after that that we know that the rate of complications started to increase dramatically," she recently told the "Washington Watch" program. "It appears that they're not even looking at the right data to be able to pull those complications."
Francis argues that political considerations are taking priority over patient safety and standard medical protocols.
"This is the classic example of the abortion distortion, which is where access to abortion is prioritized over everything else, including the health and safety of women and girls across this country," she lamented.
Susan B. Anthony Pro-Life America President Marjorie Dannenfelser has also criticized the FDA's handling of the review as inadequate, urging the Trump administration to immediately restore in-person dispensing requirements because delays could allow thousands more abortions and leave women vulnerable to coercion and abuse.
Alliance Defending Freedom has criticized the timeline for the review, likewise arguing that the agency should immediately restore in-person dispensing requirements and resolve a lawsuit challenging its removal of those safeguards.
Francis' organization has also cited separate analyses of commercial insurance claims that it says found substantially higher complication rates than those reported by the FDA.
Following a court-ordered update from the Justice Department, preliminary study results are not expected until mid-December, with a full report delayed until early next year. The FDA's broader safety study is expected to be completed by March 2027.
It's possible the president is seeking a stronger scientific and legal basis for changing restrictions, but this path seems to conflict with the Trump administration's pro-life commitments, and the lengthy review has frustrated pro-life advocates who want immediate action to protect women and unborn children.
Pro-life medical groups are urging the agency to reinstate in-person dispensing requirements or consider removing mifepristone from the market entirely.
