Last week, Amna Nawaz of PBS News asked Dr. Marty Makary, new commissioner of the Food and Drug Administration, if he planned to impose restrictions on the distribution and use of mifepristone and misoprostol in chemical abortions. The FDA approved mifepristone for chemical abortions in 2000, after a selective, limited study determined that it was “safe and effective.” Since 2016, citing that conclusion, the FDA eroded all safeguards on chemical abortions. Today, chemical abortions can be prescribed in every state, without an in-person visit, by someone who is not a physician, and distributed through the mail. Women self-administer the abortion drugs at home without a required follow-up visit. Clinics or administrating entities are not required to report adverse effects.
Even so, Dr. Makary said that he “ha(d) no plans to take action on mifepristone,” but then added:
I believe as a scientist, you got to evolve as the data comes in.
And, as you may know, there is an ongoing set of data that is coming into FDA on mifepristone. So, if the data suggests something or tells us that there’s a real signal, then I — we can’t promise we’re not going to act on that data that we have not yet seen.
Almost on cue, a new report was released on Monday by the Ethics and Public Policy Center. Whereas the FDA originally relied on data from 10 clinical trials with nearly 31,000 participants, the new data is based on the “largest-known study of the abortion pill” and “is based on analysis of data from an all-payer insurance claims database that includes 865,727 prescribed mifepristone abortions from 2017 to 2023.” In other words, this data is the most recent available and is far more representative of the chemical abortions typically obtained today. The women in this dataset are,
[B]roadly representative of the women who obtain mifepristone abortions in the U.S.; they are not a prescreened group of generally healthy women recruited into various clinical trials conducted at different times around the world.
Also, the medical care these women received is common to chemical abortions and not “the carefully controlled regimen of care that ordinarily prevails in clinical trials.”
The results, according to this analysis, is that the abortion pill harms women. Some of the disturbing findings found that 10.93% of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion. The real-world rate of serious adverse events following mifepristone abortions is at least 22 times as high as the summary figure of “less than 0.5%” in clinical trials reported on the drug label.
Of course, even if the new study suggested that mifepristone is “safe and effective” for women, it would still be a dangerous lie to claim, as proponents have, that it is “like Tylenol.” As Ob-Gyn physician Dr. Christine Francis argued in a What Would You Say video, having an abortion is nothing like treating a headache. When Tylenol works, pain is eliminated. When mifepristone works, a developing human life in the womb is ended. “If the medication is successful,” Francis observed, “someone always dies. That is the furthest thing from safe.”
Even more, women are not sufficiently warned that they are, to put it gently, likely to see the result of their chemical abortion. What the EPPC study does not quantify is the emotional and psychological trauma that women have experienced.
Also, like the data used by the FDA to justify its systemic reduction of all restrictions on mifepristone, the comparison with Tylenol is misleading and false. The claim is based on the total number of hospitalizations of each, but that comparison is “terribly misleading” since so many more people take Tylenol than mifepristone. When compared on a per capita basis, there is no comparison.
In the interview with PBS News, Dr. Makary called himself “a data guy.” I believe that he is. At the very least, these data findings require a reexamination of the FDA’s current regulations and protocol on chemical abortions. The Ethics and Public Policy Center further recommends:
The FDA should reinstate the original patient safety protocols that were required when mifepristone was first approved. Doing so will likely reduce the harms to women and permit better monitoring to determine whether this drug should remain on the market.
Certainly, it should not remain on the market. But this study is incredibly important to reverse some of the damage the FDA has caused. The stakes could not be higher. Today, the vast majority of chemical abortions “are performed using a combination of mifepristone and misoprostol,” and “chemical abortions now account for nearly two-thirds of all abortions in the United States.” Fifteen years ago, the world learned that the mass-murdering abortionist Kermit Gosnell had been enabled by a severe lack of oversight and regulation. This new report from the EPPC suggests that chemical abortion is its own “house of horrors.”
Copyright 2025 by the Colson Center for Christian Worldview. Reprinted from BreakPoint.org with permission.
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