Show-Me State Times

U.S. Senator Josh Hawley from Missouri has addressed a letter to the FDA Commissioner, Marty Makary, emphasizing the need to re-evaluate the safety regulations concerning the abortion drug mifepristone. Hawley's appeal comes following new research that suggests the risks associated with mifepristone are significantly higher than those indicated by current FDA reports.

In the letter, Senator Hawley refers to comments by Dr. Makary, where he expressed having "no plans to take action" on the drug mifepristone. Hawley urges the Commissioner to reconsider his stance, stating, "[D]uring your confirmation hearing, you pledged to me that you would ‘review the totality of the data and ongoing data’ to inform action on the drug. I urge you to follow this new data and take all appropriate action to restore critical safeguards on the use of mifepristone. The health and safety of American women depend on it."

The research cited by Hawley, from the Ethics and Public Policy Center, reviews over 865,000 cases where mifepristone was prescribed. The findings indicate that nearly 11% of women experienced severe adverse effects such as sepsis, infection, hemorrhaging, emergency room visits, or other significant health events within 45 days of taking the medication. This figure is substantially higher than the nearly 0.5% rate shown on the FDA-approved drug label.

Senator Hawley underscores the urgency, stating, "The time to act is now. It is time to revisit and restore the FDA’s longstanding safety measures governing mifepristone."

The letter also highlights the changes in regulations that occurred during previous Democratic administrations, namely those under Presidents Obama and Biden, which Senator Hawley claims have reduced or removed essential safety protocols around mifepristone.

Senator Hawley has requested a response from the FDA by May 15, 2025, addressing whether they plan to restore previous safety measures, update the drug's safety label, and evaluate mifepristone's effects on women's health.

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