HYDE-SMITH SUGGESTS RESTORING FDA ABORTION DRUG SAFETY MEASURES IN LIGHT OF NEW DATA
At Hearing, Miss. Senator Says Higher Rates of Adverse Mifepristone Reactions Merit Serious FDA Review
WASHINGTON, D.C. – U.S. Senator Cindy Hyde-Smith (R-Miss.), chair of the Senate Pro-Life Caucus, is suggesting that new data should prompt the Food and Drug Administration (FDA) to begin restoring abandoned safety requirements regarding Mifepristone, the chemical abortion drug.
At an appropriations subcommittee hearing Thursday on the FY2026 FDA budget request, Hyde-Smith asked FDA Commissioner Martin A. Makary, M.D., M.P.H., about reinstating the original safeguards on Mifepristone in light of new data published by the Ethics and Public Policy Center (EPPC) showing higher levels of adverse reactions to the drug.
“This data reveals a much higher risk from the abortion drug Mifepristone than previously acknowledged,” Hyde-Smith said. “It makes me question if the FDA should reinstate the original safeguards in order to protect vulnerable women and minors from experiencing the horrible adverse and life-threatening complications that could follow a chemical abortion regimen.”
Hyde-Smith cited findings from EPPC and the Foundation for the Restoration of America researchers, who America reviewed the outcomes of 865,727 drug-induced abortions from 2017 to 2023. All these abortions occurred after the FDA stopped requiring doctors to report non-fatal adverse complications. Among the findings:
- 10.93 percent of women experience serious or life-threatening adverse events—such as sepsis, hemorrhage, infection, or emergency surgery—within 45 days of taking the abortion pill.
- This real-world complication rate is 22 times higher than what the FDA currently acknowledges on the mifepristone label.
“If serious complications have increased as safety rules have been loosened over the last 25 years, then logically, it makes sense to bring those safety protections back. At the very least, the FDA should restore the original safety requirements from 2000 under its Risk Evaluation and Mitigation Strategy,” Hyde-Smith said.
Asked whether the FDA would review this data to restore commonsense protections, Makary said his agency would take a “hard look” at available data.
“I think a lot of people are asking those questions,” Makary said. “I did see those topline results that you referenced and we are going to take a look at those data as they become available. There is no peer-reviewed publication and the underlying data set is not available, but when it does become available we're going to take a hard look at it.”
###