US Senators James Lankford (R-OK) and Bill Cassidy (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, have led a group of Republican senators in questioning the Food and Drug Administration’s (FDA) recent approval of a new generic chemical abortion drug. The senators expressed concerns about the safety of the drug for women and argued that the decision goes against President Trump’s pro-life agenda.
The group of senators includes Tommy Tuberville (R-AL), Rand Paul (R-KY), Josh Hawley (R-MO), Pete Ricketts (R-NE), Mike Lee (R-UT), Jim Risch (R-ID), John Cornyn (R-TX), Lindsey Graham (R-SC), Ted Budd (R-NC), Marsha Blackburn (R-TN), Roger Wicker (R-MS), Jon Husted (R-OH), Steve Daines (R-MT), Tim Scott (R-SC), and Mike Rounds (R-SD).
In a letter to FDA Commissioner Marty Makary, the senators wrote, “To be clear: this approval fails to mitigate the risks to women that have been identified and fails to protect women from the coercive use of the drug. It also flies in the face of President Trump’s strong statement that he is ‘the most pro-life president’ in history and his dedication to protecting the lives of unborn children and keeping women safe.”
The senators criticized the FDA for not reinstating previous safeguards for chemical abortion drugs. During confirmation hearings, both FDA Commissioner Makary and Department of Health and Human Services Secretary Robert F. Kennedy Jr. had pledged to review the safety of these drugs and consider restoring protections that had been removed by previous administrations.
“In light of the FDA’s approval of another means of chemical abortion under the same flawed REMS framework, it is imperative that you provide an update on your review of mifepristone and your plans to reinstate necessary safeguards,” the senators continued.
The letter is supported by Susan B. Anthony Pro-Life America. Marjorie Dannenfelser, President of the organization, stated, “Abortion drugs are taking the lives of unborn children, risking the lives of women across America, and undermining the sovereignty of states’ pro-life laws. Women, children and our citizens deserve better. The lawlessness surrounding the distribution of these drugs—kicking the physician out of the doctor-patient relationship—has put drugs in the hands of abusers of underage girls and women. The horror stories and facts roll in daily, yet the response from the FDA was to approve a cheaper version of a drug that ends unborn lives and sends women to the ER. We are deeply grateful to Chairman Cassidy and his Senate colleagues for leading this critical oversight letter to the FDA.”
The senators’ letter highlights concerns about changes to the Risk Evaluation and Mitigation Strategies (REMS) for mifepristone. They note that a 2016 policy change removed requirements for prescribers to report non-fatal adverse events, which they argue has left the FDA without important safety data. The letter also points to the removal of the in-person dispensing requirement for mifepristone during the COVID-19 pandemic, which became permanent in 2023. The senators argue that this change could increase risks to women by allowing access to the drug without a medical examination.
Citing news reports, the letter mentions cases where women were forced to take chemical abortion pills without their knowledge, or where individuals obtained drugs through the mail to coerce others. The senators request that the FDA provide an update on its review of mifepristone and any plans to reinstate safeguards by October 30, 2025.
