'Fool's gold': Pro-life groups trash FDA abortion pill safety review as sham after details exposed

A federal court this past spring gave the Food and Drug Administration six months to prove it was making progress on a promised safety review of the abortion pill mifepristone, in Louisiana's litigation challenging the Biden administration's relaxed prescribing conditions, or the judge might reimpose politically popular restrictions including in-person dispensing.

That deadline came Wednesday, a month before midterm elections projected to rip the House if not the Senate away from Republicans, and pro-life groups crucial to mitigating Democratic inroads are crying foul at the Justice Department's status report to U.S. District Judge David Joseph, which finally describes the review's sources and timeline after nearly a year of vagaries.

A final safety-review report won't be completed until March 2027, and the status report makes no mention of reviewing commercial databases or "crucial Medicaid data" following the permanent elimination of the in-person dispensing requirement in 2023, opening the floodgates to pills by mail, as Susan B. Anthony Pro-Life America President Marjorie Dannenfelser fumed.

The supposed "gold-standard study," in the words of Health and Human Services Secretary Robert F. Kennedy Jr., is actually "fool’s gold," Dannenfelser said, mocking FDA Commissioner nominee Heidi Overton's pledge to Senate Republicans that the study will be done "in the most durable scientific way possible and the results communicated transparently."

Live Action President Lila Rose, who made international waves in 2024 by publicly abandoning Trump's re-election, blasted the FDA for the March 2027 completion deadline yet "no deadline for taking action" on mifepristone's risk-mitigation evaluation and mitigation strategy (REMS), through which it would change prescribing conditions.

"This delay is UNACCEPTABLE," she wrote in an email blast. "The FDA must pull the abortion pill from the market NOW."

The safety review's details continue the sins of Democratic predecessors, in the view of pro-life groups: intentionally looking away from data that could reveal a higher rate of complications from mifepristone when followed by misoprostol, which evacuates the uterus.

The movement's disillusionment with the president's second term, after a first term that clinched the elimination of federal abortion rights via three Supreme Court appointments, is emblematic of a voter enthusiasm gap going into midterms – what the political analyst Charlie Cook recently termed a "red undertow" rather than a blue wave.

Only 30% of Trump's 2024 voters are "very enthusiastic" about voting in midterms, in contrast to 48% of Democratic nominee Kamala Harris's voters, according to a six-day Reuters-Ipsos poll that ended Monday. For ordinary enthusiasm, those figures are 21% for Trump voters and 18% for those of Harris. 

Among Harris backers, 76% said they're likely to vote, in contrast to 63% of Trump's backers. The poll's margin of error was 3 percentage points.

A financial behemoth in primary and general elections on behalf of preferred GOP candidates and nominees, SBA Pro-Life America has repeatedly warned the administration that GOP midterm turnout will crater unless it settles the Louisiana litigation by restoring in-person dispensing as the safety review continues.

Busy reviewing multiple 'citizen petitions' and following contrary court orders

The FDA's 2016 removal of mandatory non-fatal adverse event reporting from the mifepristone REMS, based on its allegedly clean 15-year safety record, prompted the 5th U.S. Circuit Court of Appeals to block the 2023 removal of in-person dispensing that made permanent a COVID-19 emergency order, functionally circumventing red states' pro-life laws.

The Supreme Court has repeatedly blocked 5th Circuit mifepristone orders in various litigation, however, leaving its judges shrugging last month at what they can do without getting overturned again until the conclusion of a full district court proceeding.

The FDA is "on track to obtain study results by mid-December 2026," then to review and evaluate the results and draft a report "not later than March 2027," DOJ's status report says. "FDA anticipates that it will be able to provide an update" at that point on whether and how it will revise the REMS for mifepristone.

The agency has completed a feasibility assessment to determine "whether there are enough exposures (the number of persons who receive the interventions of interest) and outcomes (the adverse events of interest) available for the study across relevant time periods," settling on 100,000 women each for "mifepristone and the comparator group."

It will compare the two-drug cocktail's "profile to that of surgical abortion through 70 days gestation" – President Obama's FDA expanded the usage window from 49 days – and statistically data mine the results to "discover unknown safety concerns (if any)," using what's known as a TreeScan analysis.

The agency is using "a variety of data sources" within its Sentinel 2.0 distributed database for monitoring the post-market safety of drugs, datasets of which are hosted by external partners, and "continues to gather and analyze additional data outside of the Sentinel system," the status report says.

It emphasizes the FDA is both reviewing "multiple pending Citizen Petitions" to reinstate removed provisions such as in-person dispensing, for which "hundreds of public comments have been submitted," and subject to two court orders to reconsider the 2023 REMS in abortion-rights challenges that portray its conditions as still too restrictive.

Even if the FDA restricts the pill's conditions in a revised REMS, that translates to 90,000 mifepristone-enabled abortions in states that ban the pill by the end of March, Dannenfelser said in an email blast. The administration is leaving more women "vulnerable to coercion and abuse because basic medical oversight is absent."

Both SBA Pro-Life America and Live Action pointed to new research on the gap between the evidence and the loosening of mifepristone's restrictions, published in the peer-reviewed journal operated by the first legal challenger to the mifepristone regimen, the Alliance for Hippocratic Medicine, whose failure based on legal standing prompted red states to sue.

Authored by scholars with the Charlotte Lozier Institute, the pro-life research counterpart to the abortion-rights Guttmacher Institute, the paper said the studies the FDA cited in 2016 to remove in-person dispensing don't "adequately reflect real-world conditions" because most "included in-person exams, bloodwork, or ultrasounds," unlikely to happen online.

It alleged "possible bias" because the FDA "largely excluded" input from groups worried about the safety of the pill while citing or relying on "letters, clinical guidance, and other input from groups with financial or political incentives to support a weakened REMS."

Beyond the FDA's removal of mandatory reporting of non-fatal adverse events, providers frequently told women to "misrepresent their experience as a miscarriage if seeking treatment after taking mifepristone," according to the paper in Issues in Law and Medicine.

"This gap in complication reporting and miscoding of post-abortion treatment left regulators largely dependent on voluntary reports that fail to detect many real-world harms," yet the agency justified the REMS change by citing "a limited number of complication reports," the paper says.