(Oregon Right to Life) — The abortion drug mifepristone will now be subject to a review by the U.S. Food and Drug Administration (FDA), the federal agency’s commissioner announced this week. The move follows the recent release of a new study finding that the serious adverse reaction rate associated with mifepristone is far higher than previously reported.
FDA Commissioner Marty Makary pledged Monday that he would carry out “a review of mifepristone” alongside “the professional career scientists at the Agency who review this data.”
“FDA is committed to safeguarding public health by ensuring the safety, efficacy, and quality of the products it regulates,” he said.
Makary made the remarks in a letter to pro-life Republican Senator Josh Hawley of Missouri just a few weeks after Trump administration U.S. Health and Human Services (HHS) head Robert F. Kennedy Jr. told senators he had asked the FDA commissioner “to do a complete review, and to report back.”
National Right to Life president Carol Tobias praised the FDA’s decision in a press statement shared with Oregon Right to Life, highlighting the importance of reviewing the drug’s risks.
“The FDA owes it to the American people—especially to women—to reconsider the standards under which this drug was approved and is currently being distributed,” Tobias said. “At the very least, the agency should reinstate pre-2016 safety protocols, including in-person physician oversight, an earlier gestational cutoff, and full adverse event reporting.”
In 2016, the FDA implemented a policy widening the timeframe in which mifepristone could be prescribed during pregnancy. It also removed the requirement to report complications that do not result in death. In 2021, during the COVID-19 pandemic, the FDA permitted mifepristone to be prescribed online and distributed via mail. Local pharmacies were also authorized to dispense the drugs, and in January 2023, that permission was extended to retail pharmacies like Walgreens and CVS.
In her press statement, Tobias emphasized that a review of mifepristone safety is “a matter of public health and ethical responsibility.”
The announcement of the FDA review follows close upon the late April release of blockbuster new research on the abortion pill published by the Ethics and Public Policy Center.
The study, based on an analysis of public and private insurance claims submitted by 330 million U.S. patients from 2017 to 2023, calculated the severe complication rate associated with the drug to be twenty-two times the one currently listed on the drug’s official FDA label.
READ: Report: Abortion Pills Result in Serious Complications in at Least One in Every Ten Cases
According to the research, 10.93% of the 865,727 women prescribed mifepristone for abortions over the seven year period suffered a serious adverse event within 45 days of taking the drug. That percentage dwarfs the less than 0.5% rate of severe adverse event rate listed on the current FDA label for the two-drug mifepristone and misoprostol regimen.
EPCC researchers have urged the FDA to “immediately reinstate its earlier, stronger patient safety protocols to ensure physician responsibility for women who take mifepristone under their care, as well as mandate full reporting of its side effects.”
The EPPC report carries strong significance in a post-Roe v. Wade nation in which chemical abortions have become increasingly common, especially as a way of getting around pro-life state laws that have led to the closures of brick-and-mortar abortion facilities across the country. In 2023, chemical abortions accounted for 63% of all abortions nationwide – up from 53% in 2020.
RELATED: U.S. Lawmaker Urges Trump DOJ to Reconsider Call to Dismiss Abortion Pill Lawsuit
If its findings correspond with the EPCC research, the newly announced FDA review could lead to significant changes to the prevalence of mifepristone, potentially shielding many women from serious medical risks and protecting the lives of many unborn babies.
