Push for Stricter Mifepristone Regulations Gains Traction with FDA Review Pledge
Missouri Senator Josh Hawley announced a significant development in the ongoing debate over the safety of the chemical abortion drug mifepristone. Hawley revealed that Health and Human Services Secretary Robert F. Kennedy Jr. has pledged to conduct a comprehensive review of the drug’s safety profile, citing new data that raises concerns about its risks. Hawley stated, “A new study on the chemical abortion drug shows 11% of women experience adverse effects serious enough to send them to the ER. [Secretary Kennedy] just pledged to conduct a top-to-bottom review of the drug – and said the FDA label needs to change. That’s a win for life.”
Read More
The study, published by the Ethics and Public Policy Center (EPPC) on April 28, analyzed 865,727 mifepristone abortions between 2017 and 2023. It found that nearly 11% of women—more than 1 in 10—experienced serious adverse events, such as sepsis, infection, hemorrhaging, or emergency room visits within 45 days of taking the drug. This rate is reportedly 22 times higher than the less than 0.5% adverse event rate indicated on the FDA’s current drug label under the Biden administration. Hawley emphasized the urgency of the situation, stating in a letter to FDA Commissioner Marty Makary, “The time to act is now. It is time to revisit and restore the FDA’s longstanding safety measures governing mifepristone.”
During a Senate Health, Education, Labor, and Pensions Committee hearing on May 14, Hawley pressed Kennedy on the issue. He referenced the EPPC study, asking, “Since the last time you and I spoke, there’s been a major study by the Ethics & Public Policy Center of 865,727 prescribed cases of mifepristone, abortions—chemical abortions—between 2017 and 2023. Have you seen this study? Are you familiar with this?” Kennedy confirmed he was aware of the study, calling its findings “alarming” and stating, “Clearly it indicates that, at very least, the label should be changed.” He further noted that he had already directed FDA Commissioner Makary to conduct a “complete review” of mifepristone and report back.
Hawley’s Consistent Advocacy
Hawley’s advocacy for stricter regulations on mifepristone has been consistent. On April 28, he posted, “Explosive report this AM demonstrating stunning health risks of chemical abortion drugs. More than 1 in 10 women who took the drugs experienced serious ‘adverse health events’ – like hemorrhaging. The FDA needs to reinstate in-person dispensing immediately, at a minimum.” He followed up with a call to action: “I’m calling on the FDA to reinstate safety regulations on the chemical abortion drug immediately. New data out today show a massive number of severe medical side effects.”
The senator has also introduced legislation to address these concerns. On May 6, Hawley proposed the Restoring Safeguards for Dangerous Abortion Drugs Act, which aims to reinstate safety regulations removed by the Obama and Biden administrations. The bill would require the FDA to restore measures such as in-person dispensing, allow women harmed by the drug to sue telehealth providers, and ban foreign companies from mailing mifepristone into the U.S. Hawley stated, “I’m introducing the Restoring Safeguards for Dangerous Abortion Drugs Act after a bombshell study revealed the truth about mifepristone: it’s dangerous. The data shows 1 in 10 women who take mifepristone experience adverse health effects, like going to the ER or suffering from sepsis. The FDA needs to act to protect women now.”
The time to act is now. It is time to revisit and restore the FDA’s longstanding safety measures governing mifepristone. – Senator Josh Hawley
Despite these criticisms, Hawley’s efforts have garnered support from pro-life advocates. The advocacy group Susan B. Anthony Pro-Life America praised his actions, stating, “Senator Hawley is absolutely correct. We cannot let women, girls, and babies continue to be harmed by these dangerous drugs. Great to hear [Secretary Kennedy] promise to have [FDA Commissioner Makary] conduct a safety review of the high-risk drugs.”
Mifepristone was approved by the FDA in 2000 and accounts for about two-thirds of abortions in the U.S. and has been deemed safe by over 100 studies, with a complication rate lower than that of common medications like Tylenol. Hawley and his supporters argue that relaxed regulations, such as the Biden administration’s 2023 decision to allow mail-order dispensing, have compromised women’s safety.
As the FDA prepares to review the new data under Kennedy’s directive, the outcome could have significant implications for mifepristone’s regulation and access.
