The FDA’s ongoing review of mifepristone may ignore established science, health experts warn.
By Jackie Flynn Mogensen edited by Clara Moskowitz
Soumyabrata Roy/NurPhoto via Getty Images
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The Trump administration is officially investigating the safety of the abortion pill mifepristone, the Wall Street Journal reports. Health experts are concerned that the process could be politically motivated rather than science-based.
Mifepristone has been approved by the United States Food and Drug Administration since 2000 and is widely considered by healthcare professionals to be safe and effective. Last year, Health and Human Services Secretary Robert F. Kennedy, Jr. announced plans to review the safety of mifepristone, quoting concerns about a pandemic policy that allowed medications to be prescribed via telehealth. After months of no apparent progress on the review, the Trump administration faces criticism from abortion advocates, who have urged the administration to pick up the pace.
The FDA now appears to be speeding up this process. “Based on what we have seen from this administration so far, there is every reason to be concerned that this study is an exercise in cherry-picking and data distortion designed to support a predetermined conclusion of lack of safety,” said Peter Lurie, former associate commissioner for public health strategy and analysis at the FDA. has Scientific American last October, shortly after Kennedy’s announcement.
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The Trump administration says the investigation is ongoing. “The FDA has been actively working on a scientific review of the safety of mifepristone REMS. [risk evaluation and mitigation strategy] “Any reports suggesting otherwise, including that a study has only just begun, are either false or based on a fundamental misunderstanding of how complex scientific safety studies work.”
Mifepristone is currently available by mail, but legal challenges continue. Last month tthe Supreme Court extended a stay over a lower court ruling that would have made it illegal to mail the drug nationwide.
If access to mifepristone by mail is ultimately canceled, doctors could answer moving on to prescribing misoprostol, another drug that can cause an abortion, on its own. But misoprostol can cause additional side effects, which would cause more patients to seek care for possible complications and prescribers would face an additional level of complexity.
The review will take about six months, sources told the Wall Street Journaland the results will likely be released after the midterm elections in November.
Editor’s Note (06/05/26): This is a breaking news story and will be updated.
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