The Food and Drug Administration's recent review of the abortion pill mifepristone has drawn sharp criticism from medical experts and pro-life advocates who argue the agency is leaning on flawed data that cannot be trusted. The review, launched earlier this month, relies heavily on the FDA's Adverse Event Reporting System (FAERS), a database that experts say captures at most 10 percent of actual adverse events.
FAERS collects data from drug manufacturers, healthcare providers, and patients, but reporting is voluntary and often incomplete. The system is particularly problematic for mifepristone, where the three approved manufacturers—Danco Laboratories, Evita Solutions, and GenBioPro—have a direct financial stake in the drug's continued approval. Critics argue this creates an obvious conflict of interest, as these companies' business models depend entirely on mifepristone sales.
Dr. Christina Francis, a board-certified OB/GYN and CEO of the American Association of Prolife OB/GYNs, told The World Signal that the FDA's reliance on FAERS data is a critical flaw. "When the agency updated the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone in 2016, it removed the requirement to report non-fatal adverse events," she said. "This effectively means the FDA only tracks deaths, not the full range of complications like hemorrhage, infection, sepsis, or missed ectopic pregnancy."
The problem is compounded by the fact that pharmaceutical companies only learn of complications if patients or doctors voluntarily report them. Many women are unaware they can submit reports or how to do so, further skewing the data. A study cited in the original article found that the number of complications recorded in FAERS equaled only 43 percent of those noted by a single abortion provider—Planned Parenthood, which at the time provided 37 percent of U.S. abortions.
Even former FDA Commissioner Marty Makary recognized the shortcomings of FAERS data and raised concerns within the administration. His departure from the agency, following a policy shift that led to the review of Moderna's mRNA flu shot, has only heightened scrutiny of the FDA's decision-making process.
Public trust in the FDA is already fragile. A June 2026 poll from the Harvard T.H. Chan School of Public Health found that only 53 percent of Americans trust the agency's health recommendations. Similarly, Kaiser Family Foundation polling from April showed that just 36 percent of the public believe the FDA acts independently of outside interests.
Pro-life advocates, including Dr. Francis and policy strategist Gavin Oxley of Americans United for Life, argue that the FDA should use robust, real-world data sources—such as anonymized medical claims data—rather than relying on FAERS. They point to a 2025 report from the Ethics and Public Policy Center that used such data to highlight safety concerns.
The FDA's review comes amid broader political pressure, including a recent Supreme Court decision that sidestepped a ruling on mifepristone telehealth prescriptions, leaving the legal landscape uncertain. Critics warn that without a credible data foundation, the review will fail to restore public confidence.
"Our patients and our citizens deserve better," Dr. Francis said. "The FDA must prioritize transparency and accurate data if it hopes to regain trust."
