Associated Press FILE – Boxes of the drug mifepristone, a medication widely used in abortions. (AP Photo/Allen G. Breed, File) The Food and Drug Administration officially launched its review of the abortion pill mifepristone earlier this month, with internal results expected soon. And while on the surface this seems like a hopeful development, the agency’s review is destined for failure if data is sourced from “existing drug-safety surveillance systems” — namely the FDA’s Adverse Event Reporting System.
This system, commonly known as “FAERS,” is fraught with unreliability. Its data is collected directly from abortion pill manufacturers, which are required to report adverse events, as well as from medical professionals and patients (though many are unaware that they can submit reports, or how to do so). Pharmaceutical companies only know whether women experience complications if they voluntarily submit reports to them.
That means when it comes to abortion pill safety and efficacy, abortion pill manufacturers are the last place the public or the FDA should be looking for reliable post-market reporting.
Danco Laboratories, Evita Solutions and GenBioPro — the three abortion pill companies approved by the FDA to manufacture and distribute these drugs — operate business models exclusively reliant on abortion drugs. If mifepristone is proven dangerous, as the real-world data suggests it is, these companies lose everything — an obvious conflict of interest.
Pharmaceutical and public health experts have long pointed to the data-driven reality that, at most, only 10 percent of adverse events are ever documented in FAERS. Furthermore, the longer the drug is on the market, the fewer reports are ever submitted. But where reliance on FAERS data is problematic in accurately assessing the safety of any drug, mifepristone’s risk profile — including hemorrhage, infection, sepsis and missed ectopic pregnancy, among others — demands a higher level of scrutiny.
The problem goes back to the FDA itself.
When the agency updated the Risk Evaluation and Mitigation Strategy for mifepristone back in 2016, it removed the required reporting of non-fatal adverse events. These new REMS nullified FAERS data, essentially communicating to the public that the agency only cares when women die. Even when all adverse events had to be reported to the FDA, one study showed that the number of complications on the FAERS dashboard only equaled 43 percent of the complications noted by a single abortion provider (Planned Parenthood, which provided 37 percent of abortions in the U.S. at the time). A report by the U.S. Government Accountability Office noted that the only internal data used by the FDA in its 2016 review was sourced from FAERS — the same data already known to be a problematic data source.
Even former Commissioner Marty Makary understood the flaw of using FAERS data in the agency’s review and brought his concerns to the administration. The integrity of the FDA’s safety review, as well as full transparency surrounding the investigators and the data, are even more essential as institutional trust, both in scientific and governmental bodies, is failing.
A June 2026 poll by the Harvard T.H. Chan School of Public Health exemplified this distrust, finding only 53 percent of the public trusts the FDA’s recommendations “to improve health.”
Previous administrations have lost the trust of the American public, but conducting this review with “gold standard” methodology can win it back.
Similar Kaiser Family Foundation polling from April found only 36 percent of the public hold confidence the FDA will “act independently without outside interference from outside interests,” where Democrats actually hold more confidence than self-identified independents or Republicans.
Pro-life advocates and physicians have no interest in interfering with the FDA’s review of the drug. Rather, we aim to bring transparency where the agency has historically operated behind closed doors with respect to mifepristone.
For the review to withstand the necessary scrutiny it will face upon publication, the FDA must prioritize robust, real-world data sources, as it acknowledges having a “long history” of utilizing, including anonymized medical claims data such as was used in the 2025 Ethics and Public Policy Center report.
Relying on incomplete data that does not reflect the real-world conditions under which mifepristone is being dispensed (where women order it online with little to no medical supervision) robs the American public of the assurance they deserve that the FDA is advancing and protecting their health.
Our patients and our citizens deserve better.
Dr. Christina Francis is a board-certified OB/GYN who practices in Indiana and is the CEO of the American Association of Prolife OB/GYNs. Gavin Oxley is a media and policy strategist with Americans United for Life.
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