Sen. Hawley asks FDA to address concerns over incomplete data in abortion drug safety study

U.S. Sen. Josh Hawley, R-Missouri, sent a letter to Food and Drug Administration (FDA) Acting Commissioner Kyle Diamantas last week asking whether the agency “is reviewing all relevant data” in the mifepristone safety study it has undertaken.

Hawley questioned whether the study is accurately measuring risks to women of the abortion drug, which since 2021 has been available by mail. The FDA halted in-person dispensing requirements during the COVID-19 pandemic and formally modified the policy in 2023, continuing to allow abortion pills by mail.

He expressed concern that the study did not provide dates for what it called “relevant time periods” during which the drug’s effects were measured. He wrote that the study relies on Sentinel, a database of insurance claims and health records, but does not provide the time frame being analyzed. He expressed concern that data must include dates “after the Biden Administration gutted safety regulations in 2023.”

Hawley noted that Louisiana is challenging the FDA in a federal suit alleging the government did not adequately ascertain the drug’s safety before removing safeguards.

The senator asked Diamantas to provide answers in writing by…