Sen. Daines, Pro-Life Leaders Urge FDA to Reassess Abortion Pill Safety After New Study

U.S. Senator Steve Daines is calling on the Food and Drug Administration (FDA) to reinstate stricter safety protocols for mifepristone following the release of a new study that reports significantly higher rates of serious complications from the abortion drug than previously acknowledged.

The study, published by the Ethics and Public Policy Center, found that approximately 11% of women who used mifepristone experienced sepsis, hemorrhage, infection, or another serious adverse event within 45 days of administration. That rate, the authors say, is 22 times higher than what has been publicly reported by the FDA.

“The science is clear: the abortion pill is not safe for women, and it never has been,” Daines said in a statement. “This recent study is proof that pro-abortion advocates care more about promoting their radical agenda than they do about women’s health.”

Robin Sertell, chair of Montanans for Life, said the findings confirm longstanding concerns that the abortion pill has been deceptively marketed. “Women are being lied to,” she said. “They’re told that mifepristone is safer than medications like penicillin or Tylenol, but this study proves otherwise.”

Sertell also criticized the FDA’s decision to loosen safety requirements during the COVID-19 pandemic, allowing the pill to be prescribed through telehealth and taken at home. “Women are now expected to be their own abortionist,” she said. “The medical guardrails have been removed, and the result is a trail of injury and trauma that’s gone largely unreported.”

Dr. Ingrid Skop, a practicing OB-GYN and senior fellow at the Charlotte Lozier Institute, authored the study. “Chemical abortion is a public health crisis hidden in plain sight,” Skop said in an EPPC statement. She called for congressional oversight and accountability from the FDA, citing decades of underreporting and deregulation.

National pro-life groups have echoed those concerns. “This research confirms what women have suffered in silence for too long,” said Susan B. Anthony Pro-Life America President Marjorie Dannenfelser. “Mifepristone is dangerous, and the FDA’s failure to collect accurate data is a dereliction of duty. It’s time for Congress to hold the FDA accountable and stop ignoring the harm to women.”

Live Action also amplified the findings, criticizing the lack of mandatory adverse event reporting and pointing to the study’s 1 in 10 complication rate as cause for urgent regulatory reform.

Mifepristone was originally approved in 2000 under the Clinton administration and was initially dispensed only in person over multiple visits. During the COVID-19 pandemic, the FDA relaxed those requirements, allowing abortion pills to be prescribed via telehealth and delivered by mail. Under current policy, most adverse effects do not need to be reported unless the outcome is fatal.

Both Daines and national pro-life leaders are urging the FDA to reevaluate its position on mifepristone in light of the study’s findings.