HHS and FDA confirm Mifepristone investigation still ongoing in letter 

The Food and Drug Administration is continuing to investigate the risks of the chemical abortion pill, according to a letter replying to an inquiry from attorneys general in 22 states.

“The FDA continuously reviews reports of adverse events to determine, among other things, whether they are known risks or whether they are signals of emerging safety concerns,” reads the Sept. 19 letter from Secretary of Health and Human Services Robert F. Kennedy and Commissioner of Food and Drugs Martin Makary.

The update suggests the review is still ongoing but made no indication of altering current regulations. Kennedy provided nearly the same update before the U.S. Senate Sept. 4.

In the letter, Kennedy and Makary discussed the FDA’s Risk Evaluation and Mitigation Strategy (REMS) that they admitted “relaxed” requirements for mifepristone prescriptions in 2016 and 2023.

“Safeguards for women regarding the administration of mifepristone have been significantly reduced,” the letter reads.

The FDA temporarily removed the in-person doctor visit requirement during the COVID pandemic and then officially in 2023.

The letter recognized the serious “potential dangers” mifepristone may pose to women, as reported in The Ethics and Public Policy Center’s research.

“The concerns you have raised in your letter merit close examination,” the letter concludes. “This Administration will ensure that women’s health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed.”

Sen. Steve Daines, R-Montana, said he is encouraged by the FDA’s promise and will continue to work with the administration to “protect women and fight for the most vulnerable in our society.” He further emphasized how the drugs “present a clear danger to women” and why previous safeguards must be reinstated.

“These deadly drugs should not be available over the counter or online without any doctor’s care,” Daines said in a statement. “Ensuring the safety of women and the reliability of products approved by the FDA is something that all parties should agree on.”