Senator Hyde-Smith Questions FDA on Mifepristone Safety Amid New Data

New Data on Mifepristone Safety

• 💡 Mifepristone safety is being re-examined in light of new data from the Ethics and Public Policy Center.
• 📊 The data, covering over 865,000 drug-induced abortions from 2017-2023, suggests a higher risk than previously acknowledged.
• ⚠️ This new analysis indicates that 10.93% of women experience serious adverse events like sepsis, infection, or hemorrhaging within 45 days.

FDA's Role and Previous Safeguards

• 📉 The FDA removed the requirement for doctors to report non-fatal adverse complications in 2016, coinciding with the period studied.
• ⚖️ The reported real-world complication rate is 20 times greater than the rate used by the FDA during the drug's original approval.
• 🔒 Senator Hyde-Smith questions whether the FDA should reinstate original safeguards, such as requiring an in-person doctor visit, to protect women and minors.

FDA Commissioner's Response

• 🤔 Dr. McCary acknowledged seeing the topline results and stated the FDA will review the data once it becomes available.
• 🔬 He noted that the data is not yet peer-reviewed and the underlying dataset is not publicly accessible.