The Food and Drug Administration’s safety investigation of the chemical abortion pill mifepristone, used in most abortions, is progressing, according to a senior FDA official.
The official claimed that a study has been ongoing for months, as first reported by the Wall Street Journal.
“The FDA has been actively working on a science-based safety review of the mifepristone REMS [Risk Evaluation and Mitigation Strategy] for months, as the agency has stated publicly and in court filings,” an FDA official said, according to a Department of Health and Human Services statement shared with EWTN News.
“Any reporting suggesting otherwise, including that a study is just being started, is either false or based on a fundamental misunderstanding of how complex scientific safety studies work,” the official said.
The study is expected to take a total of six months, according to the Wall Street Journal report. It could be released in July, according to a CBS report.
Throughout Donald Trump’s presidency, pro-life advocates have been calling for regulation of the abortion pill mifepristone and for a reinstation of in-person dispensation amid abortion pill poisonings and safety concerns for women.
A 2025 study found that 1 in 10 women experience serious adverse events after taking the abortion pill mifepristone. Studies often have difficulty estimating the exact number of adverse effects due to loose reporting requirements and chemical abortions supplied by companies outside the U.S. healthcare system.
“In 2016, the FDA, under the Obama administration, told abortion providers, hospitals, and emergency rooms that, even if there are complications, they no longer needed to report these ‘adverse’ events to the FDA, only deaths,” Carol Tobias, president of National Right to Life, told EWTN News. “That action allows abortion proponents to make the outrageous claim that ‘mifepristone is safe because no complications have been reported.’”
Tobias celebrated the current move by the FDA.
“We are happy that the FDA is looking into the so-called safety of abortion pills,” Tobias said.
But another pro-life group urged the current administration to do more to protect women and children.
When asked about the development, Susan B. Anthony Pro-Life America urged the administration to settle a case related to the abortion pill, Louisiana v. FDA, “to end mail-order abortion drugs.”
“The FDA admits abortion drugs are more dangerous to women than many of them know,” the group said in a statement shared with EWTN News. “As many as 1 in 11 women experience serious side effects such as hemorrhage, infection, and sepsis.”
“Every month the DOJ waits to settle in Louisiana v. FDA, 15,000 more unborn children die in states with pro-life laws, women experience life-threatening side effects from mifepristone, and abusers obtain abortion drugs to poison women,” the statement continued.
