Health and Human Services Secretary Robert F. Kennedy Jr. has ordered a complete FDA review of mifepristone after disturbing new data reveals the abortion pill may be 22 times more dangerous than currently labelled.
At a Glance
- RFK Jr. has directed the FDA to conduct a comprehensive review of the abortion pill mifepristone following alarming new safety data
- A major study found nearly 11% of women experienced serious adverse events after taking mifepristone, far exceeding the FDA’s labeled risk of 0.5%
- The study analyzed insurance claims from over 865,000 mifepristone prescriptions between 2017 and 2023
- More than 5% of women required a second abortion attempt after the pill failed
- Pro-life advocates have welcomed Kennedy’s decision to reassess the medication’s safety profile
Alarming New Safety Data Prompts Review
During a recent Senate committee hearing, Health and Human Services Secretary Robert F. Kennedy Jr. revealed he has ordered FDA Commissioner Dr. Marty Makary to conduct a thorough reassessment of the abortion drug mifepristone. The directive follows a comprehensive study by the Ethics & Public Policy Center that analyzed insurance claims data from 865,727 mifepristone prescriptions between 2017 and 2023. The research uncovered troubling statistics about the medication’s safety profile that significantly contradict current FDA labeling information.
“It’s alarming,” Kennedy stated during the hearing. “I have asked Marty Makary, who is the director at FDA, to do a complete review and report back.”
The study’s findings revealed that 10.93% of women experienced serious adverse events such as sepsis, infection, or hemorrhaging within 45 days of taking mifepristone. Senator Josh Hawley emphasized during questioning that this rate is approximately 22 times higher than what appears on the FDA’s current label, which states a risk of less than 0.5%. Additionally, researchers discovered that more than 5% of women required a second abortion procedure after the medication failed to terminate the pregnancy as intended.
Label Changes and Regulatory History
Mifepristone was initially approved by the FDA in 2000 for use up to seven weeks into pregnancy. During the Obama administration, this approval was extended to allow usage up to 10 weeks. More recently, the FDA removed requirements for in-person acquisition of the medication, permitting its purchase online. These regulatory changes have increased access to the medication while potentially reducing medical supervision for patients experiencing complications.
“Clearly, it indicates that at the very least the label should be changed,” Kennedy stated, referring to the significant discrepancy between the actual adverse event rate and what’s currently disclosed to patients and providers.
The Ethics & Public Policy Center, which conducted the study, is a conservative think tank focused on applying Jewish and Christian traditions to contemporary policy issues. Their research methodology involved analyzing a large dataset of insurance claims rather than relying on voluntary adverse event reporting, which may provide a more comprehensive picture of real-world complications.
Conservative Response and Political Implications
The announcement of the review has been welcomed by pro-life advocates who have long expressed concerns about the medication’s safety profile and the regulatory framework surrounding it. Many conservatives had been curious about Kennedy’s position on reproductive issues, and this directive provides some clarity on his approach to abortion medication regulation, focusing on accurate labeling and patient safety rather than outright prohibition.
“We applaud Robert F. Kennedy Jr. for his swift directive to FDA for a thorough study of the dangerous chemical abortion pill,” said Doug Truax from the Foundation for the Restoration of America.
Kennedy has previously expressed nuanced views on abortion, acknowledging its complexity while opposing state intervention in women’s reproductive choices. His focus on ensuring accurate safety information aligns with his broader emphasis on transparency in healthcare and pharmaceutical regulation. During the same Senate hearing, Kennedy also defended proposed budget cuts to HHS, stating they would generate savings without impacting critical services to the American public.
Implications for Women’s Health
The review could have significant implications for how mifepristone is prescribed and regulated in the United States. If the FDA determines the current labeling understates the risks, providers may be required to offer more comprehensive counseling about potential complications. The agency could also potentially reinstate restrictions on how the medication is distributed. The study’s finding that over 5% of women require a follow-up surgical abortion due to incomplete termination raises additional questions about the drug’s efficacy claims.
Kennedy’s directive represents a substantial regulatory development for a medication used in approximately 63% of all abortions performed in the United States. The timeline for the FDA’s review and any potential regulatory changes has not yet been announced, but the matter has clearly been prioritized by the HHS Secretary based on the concerning safety data presented during the Senate hearing.
