A coalition of 22 Republican attorneys general is calling on the Trump administration to reinstate stringent safety measures for mifepristone, a key drug used in medication abortions, citing significant health risks to women. In a compelling letter to Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin Makary, obtained by Fox News Digital, the group argues that the drug’s current accessibility overlooks critical safety concerns, urging immediate action.
Alarming Data Creates Concern
Recent studies have cast a shadow over mifepristone’s safety profile, prompting the attorneys general to act. “Recent comprehensive studies of the real-world effects of the chemical abortion drug mifepristone report that serious adverse events occur 22 times more often than stated on the drug’s label, while the drug is less than half as effective as claimed. These facts directly contradict the drug’s primary marketing message of ‘safe’ and ‘effective,’” the letter states, referencing findings from the Ethics and Public Policy Center.
The report reveals that 1 in 10 women using mifepristone face a “serious adverse event,” such as severe bleeding, emergency room visits, or ectopic pregnancies. These findings challenge the FDA’s initial approval of the drug in 2000, which followed “a thorough and comprehensive review” deeming it safe and effective.
A Call to Restore Protections
Led by Kansas Attorney General Kris Kobach, the coalition is pressing the FDA to bring back safety protocols established in 2011 under the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. These measures, later dismantled during the Obama and Biden administrations, were designed to ensure safe use.
“Based on that review, the FDA should consider reinstating safety protocols that it identified as necessary as recently as 2011 in its issuance of a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, but which were removed by the Obama and Biden administrations,” the letter urges. If reinstating these safeguards proves unfeasible, the group suggests withdrawing mifepristone from the market.
This push follows Kennedy Jr.’s directive to Makary to scrutinize the latest data on mifepristone. Missouri Senator Josh Hawley also amplified the call, urging swift action in a letter last month. While Makary has indicated no immediate plans to alter mifepristone policies absent clear safety concerns, the mounting pressure signals a pivotal moment for the drug’s regulation.
Accessibility Under Scrutiny
Medical abortions accounted for over half of U.S. abortions in 2023, per the Guttmacher Institute. Yet, the attorneys general criticize the ease of obtaining Mifepristone, noting that “currently, a woman can obtain a mifepristone abortion by participating in only one telehealth visit with any approved healthcare provider (not necessarily a physician), ordering the drugs through a mail-order pharmacy, and self-administering them.” They also highlight lax reporting requirements, where prescribers only need to report adverse events if a patient dies.
The rollback of safety protocols in 2016 and 2023 has raised questions about the FDA’s priorities. “The FDA’s removal of these crucial safety protocols in 2016 (and in 2023) that only five years before the FDA considered necessary begs the question of whether the removal was motivated by considerations other than the safety of patients,” the letter contends.
A Shifting Legal Landscape
The debate follows a 2024 Supreme Court ruling that upheld mifepristone’s availability, rejecting efforts to curb access nationwide. The court avoided weighing in on whether the FDA’s decisions to relax restrictions were lawful, leaving the issue unresolved.
As the Trump administration grapples with these demands, the attorneys general express optimism about the FDA’s commitment to public health. “The current FDA’s dedication to the health and wellbeing of all Americans is encouraging, as is the much-needed review of mifepristone that Secretary Kennedy has promised,” they conclude.
The Fairview Gazette will keep you informed on any updates regarding new regulations surrounding mifepristone.
