Inside the FDA's Mifepristone Safety Study: Why the WSJ Report Is Alarming Reproductive Health Advocates — and What It Could Mean for Abortion Access Across America

FDA's Mifepristone Safety Study: What the WSJ Report Reveals and Why It Matters

The US Food and Drug Administration (FDA) is officially conducting a comprehensive safety study of mifepristone — the most widely used abortion drug in the United States — and the stakes could not be higher for the approximately 65% of American women who choose medication abortion as their method. The Wall Street Journal recently confirmed reporting that the review is underway, detailing a process that was formally launched in September 2025 when Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary wrote to 22 Republican state attorneys general to announce the agency's review of mifepristone's safety and efficacy. Health researchers say they're concerned that the review will be politicized and based on flawed reports. More than 100 studies published over the past few decades have shown that the drug, which was approved by the FDA in 2000, is safe and effective at ending a pregnancy. Here is everything you need to know about the FDA's abortion pill safety review — what triggered it, what it covers, who is driving it, and what it could mean for abortion access in post-Roe America.

What Exactly Is the FDA Studying — and Why Now?

Mifepristone (brand name Mifeprex) is an oral drug typically used in combination with a second drug, misoprostol, to induce a medication abortion or help manage an early miscarriage. Mifepristone, used alongside misoprostol to terminate pregnancies, has been approved as a safe and effective drug by the FDA since 2000. The FDA prescribing information notes that 10 clinical trials with collectively more than 30,000 patients found that serious adverse effects occur in fewer than 0.5% of patients. In the 26 years since its approval, mifepristone has been taken by millions of women, and the scientific consensus on its safety record has been consistent across the peer-reviewed literature.

The FDA is reviewing evidence about the safety and efficacy of mifepristone to investigate how it can be safely dispensed. Kennedy and Makary said the FDA would conduct "its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy" of mifepristone, writing: "This Administration will ensure that women's health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed."

Crucially, the formal HHS/FDA statement about the review's scope is careful: an HHS spokesperson stated the agency "is conducting a study of the reported adverse effects of mifepristone to ensure the FDA's risk mitigation program for the drug is sufficient to protect women from unstated risks." The phrase "risk mitigation program" points specifically to the FDA's Risk Evaluation and Mitigation Strategies (REMS) framework — a regulatory tool the FDA uses for drugs with known serious risks to ensure they are dispensed safely. Mifepristone has been subject to a REMS program since its approval, and the current review is focused on whether that program needs to be strengthened — potentially by reimposing restrictions that were relaxed in recent years.

The Political Trigger: 22 Republican AGs, the EPPC Study, and RFK Jr.'s Intervention

The FDA's safety review did not emerge from scientific necessity — it emerged from political pressure. A study cited by the Republicans, Kennedy and Makary was conducted by the Ethics and Public Policy Center (EPPC), a conservative think-tank whose president formerly worked at the Heritage Foundation, which published Project 2025. The study was not peer-reviewed or published in a scientific journal. It reported that almost 11% of women experienced a "serious adverse event" due to mifepristone, which is much higher than the 0.5% rate found in clinical studies and listed by the FDA on the medication label.

Despite being widely criticized for methodological flaws, lack of transparency, and distortion, findings from the report have been used to amplify false claims that mifepristone is unsafe. The scientific community's response to the EPPC study was swift and nearly unanimous in its criticism. The FDA has "not identified any new safety concerns" with Mifeprex or the approved generic mifepristone to terminate pregnancies through 70 days gestation, the agency said in an online Q&A last reviewed in April 2026. "We've been using mifepristone in the US for over two decades and we aren't seeing legitimate studies that are documenting any medical fallout or medical complications from this drug," Rachel Jones, a Guttmacher Institute principal research scientist, told reporters. Nevertheless, the EPPC study provided the political pretext for 22 Republican attorneys general to formally request an FDA safety review — and the Kennedy-Makary letter of September 2025 granted that request.

Kennedy already told senators that the FDA is collecting new data for a safety review of mifepristone and that "those studies are progressing and that they're ongoing." Kennedy claimed that the Biden administration "twisted the data" on mifepristone to "bury one of the safety signals," but didn't provide additional details about what the safety issue could be. These claims are directly contradicted by independent research. According to a January 2026 study by Johns Hopkins Bloomberg School of Public Health, a review of 264 internal FDA documents totaling 5,239 pages found the agency generally followed cautious and evidence-based recommendations from staff scientists regulating mifepristone from June 2011 to January 2023.

What Changes Could the FDA Safety Review Trigger?

The central concern for reproductive healthcare advocates is not whether the FDA will formally conclude mifepristone is unsafe — the scientific literature makes such a conclusion extraordinarily difficult to justify — but whether the review process will be used as a mechanism to reimpose access restrictions that were progressively relaxed over the past decade. The specific policy changes that critics of mifepristone have been pushing for include:

• Reversal of Telehealth Prescribing: In 2023, the FDA stopped requiring doctors to dispense mifepristone in person, allowing it to be prescribed via telehealth appointments and delivered by mail. That remains the situation, even in states where abortion is banned — although that could change. Reimposing the in-person requirement would effectively eliminate medication abortion access in states with abortion bans, where telehealth and mail-order are currently the primary channels through which women access the drug.
• Narrowing the Gestational Window: Mifepristone is currently approved for use through 70 days gestation (10 weeks). Pro-restriction advocates have pushed to narrow this window back to 49 days, which was the original approval limitation. A reduced window would eliminate medication abortion as an option for a significant proportion of women who discover their pregnancies after 7 weeks.
• Reimposing Pharmacy Dispensing Restrictions: Before 2021, mifepristone could only be dispensed at certified healthcare facilities. Reopening this restriction would eliminate the ability of certified retail pharmacies — including major chains like CVS and Walgreens — to dispense the drug, significantly reducing the geographic availability of medication abortion in rural and underserved areas.
• Reviving Prescriber Certification Requirements: Previous REMS requirements mandated that prescribers complete a specific certification process before they could prescribe mifepristone. Reinstating these barriers would reduce the number of providers capable of prescribing the drug and lengthen wait times for patients.

The Scientific Community's Response: Concern About a "Predetermined Conclusion"

The scientific and medical community has been vocal and unified in expressing concern about the FDA's review — not necessarily about the fact of a review, but about the political context in which it is being conducted and the methodological choices being made. "Based on what we have seen from this administration to date," says Peter Lurie, the FDA's former associate commissioner for public health strategy and analysis, "there is every reason to fear that this study will be a cherry-picking, data-contorting exercise designed to support a predetermined conclusion of lack of safety."

The concern about predetermined conclusions is rooted in the administration's own communications. Given Kennedy's history of misrepresenting scientific evidence about vaccines, autism and Tylenol, some scientists say they worry that the health secretary will base the FDA report on unreliable sources. The EPPC study — which forms the empirical basis for the Republicans' request and the Kennedy-Makary letter — has been comprehensively critiqued in peer-reviewed responses for using insurance claims data in a methodologically flawed way that dramatically inflates apparent adverse event rates by including outcomes unrelated to mifepristone in its "serious adverse events" count.

The WSJ Reporting: Slow-Walking Allegations and the Makary Firing Threat

The Wall Street Journal's coverage of the FDA's mifepristone safety review has focused on an irony that underscores the deeply political nature of the entire process: pro-life groups are growing concerned that the review is being deliberately slow-walked. For advocates who pushed for the review specifically to create the regulatory foundation for restricting mifepristone access, any delay in the process is deeply frustrating — and they have not been shy about expressing that frustration. In a May 4, 2026, letter to Acting Attorney General Todd Blanche and FDA Commissioner Marty Makary, Bishop Daniel E. Thomas of Toledo, Ohio, chairman of the US bishops' pro-life committee, wrote that while the group is "grateful for the FDA's undertaking the needed study of mifepristone," he is concerned about "reports alleging a deliberate delay in the completion of that review."

The political pressure on FDA Commissioner Makary from the anti-abortion right has become so intense that it has reportedly cost him his job. The Wall Street Journal reported that, per people familiar with the matter, Trump has officially signed off on a plan to fire Makary, amid controversy on how the commissioner has handled abortion, drug policies, and vaping. This extraordinary development — a sitting FDA Commissioner potentially being fired for insufficient speed in restricting a drug that the agency's own scientists have consistently found to be safe — illustrates the degree to which the mifepristone safety review has become a proxy battle in the broader post-Roe abortion policy war.

Timeline and What Comes Next

In February 2026, the FDA claimed the safety review would be completed in one year or sooner. In April 2026, HHS spokesperson Andrew Nixon told Bloomberg Law the FDA plans "to have this study done sooner than that timeframe." An HHS statement claimed the FDA "is conducting its safety study of mifepristone, including the collection of robust and timely data, evaluation of data integrity, and implementation of the analyses, validation, and peer-review." Once the FDA finishes its analysis of the data, the agency will decide whether to make substantive changes to how abortion pills are accessed.

However, in court filings, the Department of Justice has indicated the review may come after November's midterm elections — a timeline that would push any regulatory action derived from the review into the post-midterm political landscape, when the partisan composition of Congress may be significantly different. This political timing dimension adds another layer of complexity to an already deeply contested process.

For women who currently depend on mifepristone for medication abortion — and for the healthcare providers who prescribe it across all 50 states — the FDA's safety review represents a period of profound uncertainty. The scientific evidence for mifepristone's safety after 26 years and tens of millions of prescriptions is overwhelming and consistent. Whether that evidence will determine the regulatory outcome of this review — or whether political considerations will drive the FDA toward imposing restrictions that the science does not support — is the question that will define one of the most consequential reproductive healthcare policy decisions of the decade.