Abortion Pills are Injuring Thousands of Women Every Single Year

Just a little bit over ten months ago, the Ethics & Public Policy Center (EPPC) released a study which really upset the dominant media narrative about the safety of the abortion pill. While the abortion industry had used a few limited studies to convince the U.S. Food and Drug Administration (FDA) that serious complications were less than half a percent, EPPC looked at more than 865,000 insurance claims of actual mifepristone patients and determined that the serious adverse events rate was closer to 11%!

Abortion advocates attacked with a fury. They complained this wasn’t one of their carefully controlled clinical studies, ignoring the fact that EPPC offered documentable, real world patient data, not the industry’s hand-picked samples and spun data with its most problematic cases “lost to follow-up.”

That was last year. Now, the team at EPPC is back with new data. This makes it plain that the latest changes the FDA made to the mifepristone protocol from abortion industry data – eliminating a required in-person office visit, allowing these pills to be ordered online and mailed to a woman’s home without full screening or a physical exam – didn’t make things safer, but more dangerous.

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Revealing Data from Court Filing

Details on the new data have yet to be fully released, but the findings were made known in an amicus filing EPPC made on behalf of a case being brought by the state of Louisiana against the FDA in federal district court – State of Louisiana v. FDA. In the lawsuit Louisiana is challenging the government’s decision to abandon the in-person dispensing requirement and claiming the new rules opened the door to coercion.

That brief argues that, far from being beneficial or even neutral, the change the FDA made dropping the required in-person visit and allowing pills to be mailed without any direct screening or exam, actually made things worse, more dangerous, for mifepristone patients.  And EPPC said new data from the previous report proved it.

Full numbers and data tables are not yet available, but the EPPC amicus says its latest analysis shows,

…the rate of serious adverse events was significantly higher when the FDA’s in-person dispensing requirement was not in effect….  Indeed, the data indicates that a serious adverse event was from 1.53 to 2.33 times as likely with remote dispensing as with in-person dispensing.

Note that this is NOT saying that the adverse event rate was between 1.5 and 2.3%. It makes the case that the rate with remote (versus in-person) dispensing without the in-person visit was 1.5 to 2.3 times what it was with the in-person visit.

Abortion pill advocates say ectopic pregnancies should be counted as complications of chemical abortions since mifepristone doesn’t work in these situations. They say it is not supposed to be prescribed for ectopic pregnancies, when the child implants outside the womb, perhaps in the fallopian tube.

But this ignores how the new no-visit, no-exam protocol lends itself to these conditions going undetected. This turns dangerous when patients interpret the pain, cramping, and bleeding of a rupturing tube as the ordinary process of a chemical abortion. By the time woman and doctor figure out that this is not abortion, but a ruptured ectopic pregnancy, it may be too late.

The EPPC amicus points out that the FDA protocol change– the dropping of the in-person visit– is especially problematic for those women who take the drugs not knowing they have an ectopic pregnancy. And their new data confirms this.

The disparity was, not surprisingly, especially true of the incidence of ectopic pregnancy, a life-threatening condition that can be diagnosed by a physician only in an in-person visit. The data indicates that the provision of mifepristone to a woman with an ectopic pregnancy was from three to six times as likely with remote dispensing as with in-person dispensing.

Again, no base numbers are given here, but this would mean that the incidence of women with ectopic pregnancies being given mifepristone (the “abortion pill”) jumped by three to six times.  So, if 50 cases slipped by when the in-person visit was required, there would have been 150 or even 300 cases when the FDA dropped that requirement.

EPPC shares additional data

More information on frequency of complications before and after the Biden FDA’s decision to drop the in-person distribution requirement came from a report EPPC president Ryan T. Anderson shared with activists being briefed on Louisiana v. FDA.

Again, full data tables were not made available, but Anderson noted the severe complication rates increased after the in-person requirement was dropped. Anderson said it was 10.15% before and 11.5 percent after the FDA dropped the in-person dispensing requirement.

Without knowing how many records came in before the requirement was dropped and how many after, we cannot be certain of the numbers. However, if half the 865,727 records came in before and half after, that would mean 5,840 more women suffered serious complications because the in-person dispensing requirement was dropped.

Women who saw their prescriber in person could be ultrasonically screened for gestational age (complications increase as the baby grows older, more developed) or ectopic pregnancy (which mifepristone does not treat). Some ectopic pregnancies got through, even with the in-person screening but EPPC data clearly show more were missed once the in-person visit was scrapped.

With in-person visits required, Anderson said 0.27% claims showed an ectopic pregnancy. By contrast when that requirement was dropped, there was a 52% greater likelihood (0.41% )of seeing an ectopic pregnancy.

Split those 865,727 claims in half, assume half occurred before the FDA removed the in-person visit requirement, half after. That would mean more than six hundred additional women with ectopic pregnancy were given mifepristone inappropriately after the required in-person visits were stopped.

These are not merely statistical losses or injuries. These are women who suffered, who faced heightened risk of serious complications because of the FDA’s decision to drop one of its critical safeguards.

The FDA claimed, every time it reduced regulations, that it had seen studies (from the abortion industry) showing that women’s safety would not be jeopardized by these changes. Pro-life doctors and others pointed out that in the changes the FDA made to regulations in 2016, 2021, and 2023, it only considered smaller individual changes (changing doses, broadening the field of prescribers, extending the cutoff, reducing or eliminating visits, etc.) and not all the changes the FDA was combining together.

Sen. Bill Cassidy (R-LA) and several other members of Congress, in their own amicus brief in Louisiana v. FDA, faulted the FDA for not adequately considering the impact of these regulatory changes.

When looking at the full administrative record, it becomes clear that rather than letting science and evidence drive its decision making, the Biden FDA reached a predetermined and politically motivated conclusion to expand access to abortion drugs despite lacking enough evidence to show the change would be safe. This is a clear violation of FDA’s legal responsibilities and a fact acknowledged by current Secretary of Health and Human Services Robert F. Kennedy, Jr., and FDA Commissioner Martin A. Makary, who both stated in September 2025 that there was a “lack of adequate consideration” of the safety risks “underlying the prior REMS [Risk Evaluation and Mitigation Strategies] approvals,” including the Biden FDA’s decision to “remov[e] the in-person dispensing requirement.”

The latest data from EPPC make it clear that the Biden FDA’s decision put abortion politics and pleasing its pro-abortion allies ahead of women’s safety.

As a result, thousands of women have suffered the consequences.

LifeNews.com Note: Randall O’Bannon, Ph.D., is the director of education and research for the National Right to Life Committee.

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