U.S. Senator Bill Cassidy, chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, led a group of Republican senators in seeking information from the Food and Drug Administration (FDA) regarding its recent approval of a new generic chemical abortion drug. The senators expressed concerns that the approval could pose risks to the health and safety of women.
The letter, signed by Cassidy and several other Republican senators, stated: “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 certain safety requirements, known as Risk Evaluation and Mitigation Strategies (REMS), which they argue are necessary to protect women from serious health risks. They noted that both FDA Commissioner Marty Makary and Department of Health and Human Services Secretary Robert F. Kennedy Jr. had previously pledged to review the safety of chemical abortion drugs and consider whether to reinstate these protections.
“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 letter continued.
The advocacy group Susan B. Anthony Pro-Life America supported the letter. Marjorie Dannenfelser, President of SBA Pro-Life America, said: “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 also referenced previous actions by the Obama and Biden administrations, which removed certain reporting requirements for non-fatal adverse events related to mifepristone, as well as changes to in-person dispensing rules during the COVID-19 pandemic. They argued that these changes reduced oversight and increased risks, citing specific cases where women were allegedly coerced into taking abortion drugs without their knowledge.
The letter requested detailed information from the FDA about its review process, safety studies, and the timeline for approving the generic drug application from Evita Solutions. The senators asked for responses by October 30, 2025.
For further updates from HELP Republicans, information is available on their website or via Twitter at @GOPHELP.
