More than 20 Republican attorneys general have joined a formal call for the Trump administration to reinstate the safety protocols for mifepristone, an abortion drug, citing recent studies that suggest it poses significant risks to women. In a letter obtained by Fox News Digital, the attorneys general, led by Kansas Attorney General Kris Kobach, are urging Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drug Administration (FDA) head Martin Makary to re-evaluate the drug’s safety and potentially restore the 2011 safeguards that were removed under the Obama and Biden administrations.
The letter highlights research published earlier this year by the Ethics and Public Policy Center (EPPC), which claims that mifepristone is associated with serious adverse effects occurring 22 times more frequently than reported on the drug’s label. According to the EPPC, the drug is also less than half as effective as claimed, contradicting its marketing as ‘safe’ and ‘effective.’ The letter further notes that 1 in 10 patients undergoing the procedure may experience complications such as hemorrhage, emergency room visits, or ectopic pregnancy.
The attorneys general argue that the FDA’s removal of the 2011 safety protocols, which included a Risk Evaluation and Mitigation Strategy (REMS), raises questions about whether the decision was motivated by factors other than patient safety. They emphasize that the current FDA’s commitment to public health is encouraging, and they welcome the promised safety review of the drug by Secretary Kennedy.
This development comes after Sen. Josh Hawley, R-Mo., sent a similar letter to Kennedy Jr., urging swift action to reinstate the safety measures for mifepristone. Makary had previously stated that the FDA has no plans to change current policies unless the data reveals a significant safety issue, but the attorneys argue that the current procedures lack adequate protections for patients.
Mifepristone, which is administered alongside misoprostol to end an early pregnancy, was first approved by the FDA in 2000 after an extensive review. The FDA has maintained that the drug is safe and effective, and routine reviews have not identified new concerns. However, the attorneys argue that the lack of safeguards in the current system may jeopardize patient safety, calling for a reevaluation of its use and availability.
Meanwhile, medical groups have also urged the FDA and Kennedy to re-examine the broad approval of mifepristone and other abortion drugs. The attorneys general stress that the FDA’s removal of these safety measures in 2016 and 2023, despite its previous acknowledgment of their necessity, casts doubt on the agency’s commitment to public health. They argue that the current system allows for telehealth access and mail-order pharmacies, raising concerns about oversight and patient safety.