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| FDRLST/CANVA |
The FDA appears to be slow-walking its mifepristone review, frustrating Trump allies in both Congress and pro-life states.
It is well established that mifepristone, the popular abortion drug, is deadly to unborn babies and dangerous to women — especially those who take it without medical oversight. Confidence that the Trump administration will do anything to curb the harms wrought by the Biden administration’s radical expansion of mail-order abortion drugs, however, is dwindling.New polling from Cygnal suggests that 32 percent of Republican voters are unmotivated to show up for the midterms “if Republican leaders weaken or abandon pro-life policies.” Trump, who fears impeachment if the GOP loses control of Congress come November, can’t afford to be shunned by the pro-life base that played a pivotal role in electing and reelecting him. Yet, he has deliberately avoided addressing mifepristone and the Biden-era mail-order scheme that has contributed to the deadly drug’s popularity.
Trump’s silence is unsurprising given his history of blaming pro-life issues for Republicans’ political losses. What is surprising to the pro-life organizations and GOP legislators is that their demands that the U.S. Food and Drug Administration at least restore the mifepristone safeguards present during the first Trump administration have yet to manifest in any measurable action.
Pro-lifers believe this stalling is deliberate. SBA List Pro-Life America and Live Action’s Lila Rose used an anonymously-sourced article claiming the FDA head was “Slow Walking a Long-Awaited Abortion Pill Safety Study” to call for FDA Commissioner Marty Makary’s firing. The FDA called the accusation “baseless.”
Sen. Josh Hawley, R-Mo., told The Federalist in a phone call that he also believes, after conversations with Makary, that the FDA’s “safety study thing is just a dead end.”
“Women are being lied to, babies are being killed, and we need to do something about it. I’ve concluded that the safety study, which the FDA promised they would initiate a year ago, it just doesn’t seem to be going anywhere to me,” Hawley said.
Empty Promises?
Both U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and Makary pledged throughout 2025 to review the data suggesting the popular abortion pill drug regimen linked to hemorrhage, “fast, weak pulse,” “trouble breathing,” diarrhea, dizziness, headache, vomiting, and “pain” across the back, arms, neck, and abdomen.
The real push for the FDA to act didn’t heat up after the Ethics and Public Policy Center’s April 2025 examination of private medical insurance data determined that more than one in 10 women who take mifepristone suffer a serious adverse event such as hemorrhage or infection. The risk of contracting a life-threatening side effect linked to pill-induced abortion, according to EPPC’s findings, is at least 22 times higher than what the FDA and mifepristone manufacturer Danco Laboratories boast.
New polling suggesting a majority of likely voters also want the FDA to protect women from the dangers of abortion pills also made a debut as Congress and pro-life organizations teamed up to pressure the FDA to at least roll back Biden-era expansions that make it easier for people to obtain and take mifepristone without medical oversight.
HHS and the FDA appeared receptive to these calls to action, but ultimately failed to respond to The Federalist’s repeated questions about who is leading the review, what process the review will follow, whether it had formally commenced, and how long it is estimated to take.
Hawley said that the FDA, despite previously confirming that the mifepristone review is in “data acquisition phase” and will continue “under [Makary’s] auspices,” is “not even reviewing any data yet.”
The only mifepristone-related activity out of the FDA thus far occurred in October when the agency approved a generic version of the abortion pill for sale and distribution. The FDA claimed at the time to The Federalist that the HHS secretary was required “by law” to “approve an application if it demonstrates that the generic drug is identical to the brand-name drug.” The off-brand abortion pill, however, went unapproved for 1,207 days under the Biden administration and another 253 days under Trump until the FDA ultimately greenlit it.
Waiting on the FDA to do anything to limit mifepristone in a timely manner, Hawley added, “doesn’t seem to be remotely on the horizon.”
“The FDA could reinstate the safety protocols that President Trump had in his first term, and that would be certainly a step in the right direction. So I continue to believe that that’s what the FDA should do. I just — the safety study was supposed to be a precursor to that and they don’t even seem to be doing the study. So I just don’t have a lot of confidence that they’re going to act,” Hawley said.
No review is required for the FDA to reinstate some of the common-sense abortion pill safeguards, such as an in-person doctor visit, that were stripped from the FDA’s Risk Evaluation and Mitigation Strategy (REMS) at President Joe Biden’s behest. Doing so would bring the second Trump administration’s mifepristone policy up to speed with the first Trump administration’s parameters. Yet, the FDA recently declared it does not plan to act on those REMs until it concludes its official abortion drug evaluation.
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