FDA Head: Abortion Capsule Assessment Will Be Launched As soon as Accomplished

U.S. Food and Drug Commissioner Marty Makary confirmed on Wednesday that his agency’s review of the drug responsible for a majority of the nation’s abortions is underway and will be publicized as soon as results are finalized.

As stories of women suffering injuries and even death after taking abortion pills without medical supervision gained traction, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. pledged that the administration would “study the safety of mifepristone.” By March 2025, Makary also promised “to review the ongoing data.”

News of the review, however, remained sparse and vague for most of 2025, prompting Congress and pro-life organizations to pressure the FDA to roll back Biden-era expansions that make it easier for people to obtain mifepristone via mail or a drug store pharmacy without a doctor visit or medical oversight. Polling suggesting a majority of likely voters also want the FDA to protect women from the dangers of abortion pills, also made an appearance shortly after both Kennedy and Makary announced the FDA “is conducting its own review of the evidence.”

The FDA previously failed to respond to The Federalist’s 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. In his December 9 sitdown with the Daily Signal, however, Makary confirmed that the FDA’s mifepristone review is in the “data acquisition phase” and will continue “under my auspices.”

“It’ll be reported up to me,” he said,.

While Makary did not specify the review’s timeline or end date, he committed to publicizing the FDA’s findings as soon as they “are available.”

“We’re not going to decide what the results are before we’ve done the study,” he continued. “We’re doing the study the right way. And when you do the study the right way, and I’ve done dozens of these studies as a Johns Hopkins professor, you gotta do the studies in data the right way with the right pace.” 

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. This determined rate of life-threatening complications, such as hemorrhage and infection, after pill-induced abortion is at least 22 times higher than what the FDA and mifepristone manufacturer Danco Laboratories boast.

The FDA’s study, Makary announced, is even “bigger” and “more robust” than EPPC’s undertaking. While the EPPC study was the “largest known study of the abortion pill” at the time, Makary said “it didn’t have granularity into the patient characteristics in a way that many researchers would want to have” which is why the FDA plans to probe mifepristone with an expanded review.

Makary’s comments come shortly after Bloomberg published an anonymously-sourced article claiming the FDA head was “Slow Walking a Long-Awaited Abortion Pill Safety Study.” Pro-life group SBA List Pro-Life America used the article to call for Makary’s firing.

No review is required for the FDA to reinstate some of the common-sense abortion pill safeguards. In fact, an embrace of requirements such as an in-person doctor visit would bring the second Trump administration’s FDA up to speed with the parameters that were present during the first Trump administration. Until that happens, it is easier now than ever for anyone to obtain mifepristone regardless of state laws prohibiting it.

The majority of abortions, 70 percent, are already believed to be unwanted, coerced, or inconsistent with the mother’s values and desires. A rise in abortion pill poisoning anecdotes further confirms that abusers and other bad actors take advantage of the FDA’s currently relaxed mail-order abortion drug provisions to force mifepristone on pregnant women.

The FDA recently added more mifepristone options to the market by approving a generic version of the abortion pill. The FDA claimed 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 253 days under Trump before the FDA greenlit it.

Jordan Boyd is an award-winning staff writer at The Federalist and producer of “The Federalist Radio Hour.” Her work has also been featured in JP, Fox News, and RealClearPolitics. Jordan graduated from Baylor University where she majored in political science and minored in journalism. Follow her on X @jordanboydtx.