The head of the FDA, Commissioner Marty Makary, confirmed Wednesday that the agency’s long-awaited review of mifepristone — the abortion pill responsible for most abortions in the United States — is finally underway and will be released to the public as soon as it’s complete. In other words, accountability might finally be on the horizon after years of the Biden administration pretending nothing was wrong.
The review comes after a rising number of horror stories involving women suffering severe complications — and in some cases dying — after taking abortion pills without any medical oversight. These aren’t isolated incidents; they’ve become common enough that even HHS Secretary Robert F. Kennedy Jr. had to admit the issue was serious enough to “study the safety of mifepristone.” By March 2025, Makary joined the chorus, promising to “review the ongoing data.”
Yet throughout 2025, the FDA offered nothing but vague assurances and bureaucratic fog. No timeline. No process. No transparency. Congress — along with pro-life organizations — finally had to pressure the agency to roll back the reckless Biden-era rules that allow anyone to grab abortion pills through the mail or at a local pharmacy without even seeing a doctor. Polling shows that most likely voters want the FDA to protect women from these dangers — a fact Democrats conveniently ignore when claiming they’re the “party of women.”
The Federalist repeatedly pressed the FDA for clarity. The agency stonewalled every question. But in a December 9 interview with the Daily Signal, Makary finally confirmed what many suspected — the review is in the “data acquisition phase” and fully under his direction.
“It’ll be reported up to me,” he said — a subtle but important reminder that the adults may finally be back in charge at the FDA.
Makary didn’t provide a completion date, but he did promise the findings would be made public the moment they’re ready. And unlike past administrations that delivered politically pre-cooked “science,” Makary emphasized that the study will be done the right way — real data, real methods, real science.
That alone is a refreshing break from the activist-driven FDA we saw under Biden.
Back in April 2025, the Ethics and Public Policy Center released a bombshell analysis of private insurance records showing that more than 1 in 10 women who take mifepristone experience a serious adverse event. Let’s be clear: that’s a life-threatening complication rate 22 times higher than the rosy numbers repeated by the FDA and Danco Laboratories. For years, the Biden administration insisted the pills were “safer than Tylenol.” Women paid the price.
Makary says the FDA’s own study will be even “bigger” and “more robust,” digging deeper into patient characteristics and outcomes — the kind of detail the EPPC study couldn’t access. That’s exactly why this review matters: women deserve real data, not political propaganda dressed up as healthcare.
Unsurprisingly, the Left isn’t thrilled. Bloomberg published an anonymously sourced hit piece accusing Makary of “slow walking” the study. Pro-life groups, understandably skeptical of anything coming out of the bureaucracy, used the report to push for more accountability. But the truth remains: no “review” is even needed to reinstate the basic safeguards Biden tore down. The second Trump administration could restore Trump-era protections — such as mandatory in-person doctor visits — today.
Until then, it’s easier than ever to obtain mifepristone in defiance of state laws — a loophole that abusers and traffickers are already exploiting. A staggering 70% of abortions are believed to be unwanted, coerced, or contrary to the mother’s own values. And stories of abortion pill poisonings continue to pile up — the dark, predictable result of the Biden administration treating abortion pills like candy.
And in the latest twist, the FDA just approved a generic version of mifepristone — despite the agency claiming the HHS secretary was “required by law” to approve a drug once it meets criteria. Interesting, considering that the same generic pill sat unapproved for over 1,200 days under Biden and 253 days under Trump before magically getting the green light.
The bottom line: after years of political manipulation masquerading as healthcare policy, there may finally be a real, independent review of the abortion pill’s risks. And once those results come out, Washington’s long-protected abortion-pill industry may have a much harder time pretending women aren’t being harmed.
