WASHINGTON – U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, led Republican senators seeking answers on the Food and Drug Administration’s (FDA) recent approval of another generic chemical abortion drug that endangers the health and safety of mothers. This decision undermines President Trump’s pro-life and pro-family agenda.
Cassidy was joined by U.S. Senators Tommy Tuberville (R-AL), Rand Paul (R-KY), Josh Hawley (R-MO), Pete Ricketts (R-NE), Mike Lee (R-UT), James Risch (R-ID), John Cornyn (R-TX), James Lankford (R-OK), 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).
“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,” wrote the senators. “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.”
In addition to approving another form of the chemical abortion drug, the FDA has failed to take concrete steps to reinstate commonsense protections to safeguard women from serious safety risks. Both FDA Commissioner Marty Makary and Department of Health and Human Services Secretary Robert F. Kennedy Jr. pledged to senators in their confirmation hearings to study the safety of chemical abortion drugs and assess whether to reinstate these commonsense protections that past Democrat administrations removed.
“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,” continued the senators.
This letter is supported by Susan B. Anthony Pro-Life America.
“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,” said Marjorie Dannenfelser, President, SBA Pro-Life America. “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.”
Read the letter here or below.
Commissioner Makary:
We write to express significant concerns with the Food and Drug Administration’s (FDA) approval of another generic form of the chemical abortion drug, mifepristone,[1] and to request information about the safety studies currently being conducted on the chemical abortion regimen.
During your confirmation hearing before the Senate HELP Committee, multiple Republican senators expressed concerns with the safety of mifepristone and actions taken by the Biden and Obama administrations to remove longstanding Risk Evaluation and Mitigation Strategies (REMS) safeguards for the drug. In response to these concerns, you reiterated your commitment to “take a solid hard look at the data and to meet with the professional career scientists who have reviewed the data at the FDA and to build an expert coalition to review the ongoing data which is required to be collected as a part of the REMS program.”[2] Additionally, Department of Health and Human Services (HHS) Secretary Kennedy told senators in his confirmation hearing before the Senate Finance Committee that “President Trump . . . asked [him] to study the safety of mifepristone” and that he would “ask NIH and FDA to do that.”[3]
Despite making these commitments to senators in the beginning of the year, FDA waited nearly six months after your confirmation before announcing any concrete action to evaluate and mitigate the safety risks of mifepristone, and even then, did so in a non-public letter to state attorneys general[4] without any press release or public acknowledgement of the letter until a post on X by Secretary Kennedy on October 2, 2025.[5] The letter stated that “HHS—through the FDA—is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug.”[6] However, it does not provide any further information on the scope or other potential details of this review.
As you know, and acknowledge in the letter to the state attorneys general,[7] the Obama administration in 2016 removed the REMS requirement for prescribers to report non-fatal adverse events to the drug manufacturers,[8] depriving FDA of much needed evidence to ensure the mifepristone REMS sufficiently protects women. Secretary Kennedy acknowledged the harm this decision caused, saying in his confirmation hearing that removing the requirement to report adverse events is “against everything we believe in this country” and that “it’s immoral to have a policy where patients are not allowed to report adverse events and where doctors are discouraged from doing that.”[9] He further stated that “[w]e need to know what the adverse events are.”[10]
On top of the fact that non-fatal adverse events have not been required to be reported since 2016, leaving FDA without critical insights into the safety of the drug, the Biden administration in 2021 caved to radical left-wing activists to temporarily halt enforcement of the in-person dispensing requirement for mifepristone under the guise of the COVID-19 pandemic.[11] Then, in case it was not already obvious that the COVID-19 justification was a ruse, the Biden FDA permanently removed the in-person dispensing requirement in 2023 to further its push for abortion-on-demand across the country.[12] All of this happened without any evidence to justify the departure from 20 years of precedent requiring this dangerous drug to be dispensed in-person where a proper medical examination could be conducted to ensure a woman does not have an undiagnosed ectopic pregnancy, does not take the chemical abortion drugs too late in pregnancy, and does not have Rh-factor incompatibility that could put future pregnancies at risk, among others. You noted this fact in your letter to the state attorneys general, stating that there was a “lack of adequate consideration underlying the prior REMS approvals.”[13]
The in-person dispensing requirement also helped guard women from being coerced into having chemical abortions against their will. Since its removal in 2021, multiple news reports indicate that women have been forced to take chemical abortion pills or even given them without their knowledge. In one case in Texas, a man was convicted of repeatedly attempting to kill his unborn child by secretly spiking his pregnant wife’s drinks seven times with chemical abortion drugs.[14] In another case in Louisiana, a woman was charged with obtaining chemical abortion drugs through the mail and forcing her teenage daughter to take them to end her unborn child’s life.[15] Tragically, these are just some of the many stories of the danger caused by removing the in-person dispensing requirement.
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. 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[16] and his dedication to protecting the lives of unborn children and keeping women safe. To help inform our understanding of FDA’s work on the chemical abortion drug, please respond to the following questions, on a question-by-question basis, no later than October 30, 2025.