In a bold move highlighting growing concerns over women's health, more than 20 Republican attorneys general are urging the Trump administration to reinstate vital safety regulations for the abortion pill Mifepristone.
According to Breitbart, Led by Kansas Attorney General Kris Kobach, these officials sent a letter to Health and Human Services Secretary Robert F. Kennedy Jr. and the Food and Drug Administration, citing a recent Ethics and Public Policy Center study that reveals complication rates far higher than previously acknowledged, prompting calls for either restoring old protocols or pulling the drug pending review.
Mifepristone, the first pill in a two-drug regimen for medication abortions, gained fast-tracked FDA approval in 2000 during the Clinton administration by classifying unwanted pregnancy as a serious illness.
The original FDA label from September 2000 limited use to seven weeks of pregnancy and included safeguards like three office visits, prescriptions only by informed physicians, administration under medical supervision, and access to surgical or transfusion care if needed. These measures aimed to protect women from risks such as incomplete abortions or severe bleeding, ensuring physician oversight for assessing gestational age and diagnosing issues like ectopic pregnancies. Over two decades, however, these protections were gradually eroded through policy changes.
Under the Obama and Biden administrations, key safeguards vanished, culminating in the 2023 Risk Evaluation and Mitigation Strategy that allows telehealth prescriptions by any approved provider, mail-order delivery, self-administration, and use up to 10 weeks of gestation. In 2016, the FDA stopped requiring reports of serious adverse events except deaths, a shift that critics say may have masked rising dangers. This deregulation, the attorneys general argue, prioritized other factors over patient safety, raising questions about true motivations in a politically charged arena.
A comprehensive Ethics and Public Policy Center study, authored by President Ryan T. Anderson and fellow Jamie Bryan Hall, analyzed 865,727 mifepristone abortions from 2017 to 2023 using insurance claims data.
It found 10.93% of women suffered severe complications like sepsis, infection, or hemorrhaging within 45 days, 22 times higher than the under-0.5% rate from label-cited clinical trials. The study also deemed the drug less than half as effective as claimed, contradicting its "safe and effective" marketing and highlighting real-world risks amplified by removed safeguards.
In their letter, the attorneys general commended Kennedy and FDA Commissioner Marty Makary for pledging a safety review based on objective data following the study's release. They suggested reinstating 2011 protocols deemed necessary just years before their removal, or temporarily withdrawing mifepristone to prevent harm during evaluation. "The FDA’s removal of important safeguards starting in 2016 may explain in part why the real-world risk of serious adverse events from 2017–2023 is so much higher than the risk identified in clinical trials cited in mifepristone’s label," the letter states.
But one might politely ask: if safety was the goal, why strip away protections that once seemed essential, especially when new evidence shows such stark dangers? Mississippi Attorney General Lynn Fitch, a signatory, told Breitbart News she's hopeful the review will prioritize women's health. "The evidence is clear that there can be serious adverse health impacts for women who use this drug and we do a disservice to women to pretend otherwise," Fitch said, adding a thoughtful zinger about inconsistent warnings on unknown drugs versus mail-order abortions driven by politics.
Mifepristone blocks progesterone, deteriorating the uterine lining and cutting off nourishment to the developing baby, who dies in the womb; misoprostol then induces contractions to expel remains. Pro-abortion advocates from Planned Parenthood and the American College of Obstetricians and Gynecologists argue deregulation boosts access, particularly after the Supreme Court's 2022 Dobbs decision overturned Roe v. Wade's 50-year abortion right, returning the issue to states. Yet, in a landscape where empathy for vulnerable women should transcend agendas, sidelining safety for convenience feels like a risky bet on ideology over evidence.
Danco Laboratories, maker of brand-name Mifeprex, notes on its site that cramping and bleeding are expected, but serious issues like life-threatening infections rarely occur post-abortion or childbirth. "Seeking medical attention as soon as possible is needed in these circumstances. Serious infection has resulted in death in a very small number of cases. There is no information that use of Mifeprex and misoprostol caused these deaths," the site advises, urging contact with providers for concerns.
While this disclaimer sounds reassuring, the EPPC's data on rampant complications suggests the real story may be less benign, underscoring why balanced reviews matter in debunking overly optimistic claims.
Medication abortions hit 63% of U.S. healthcare system terminations in 2023, up from 53% in 2020 and 39% in 2017, per the Guttmacher Institute, with about 642,700 such procedures that year—not counting underground sources. Earlier this year, Idaho, Missouri, and Kansas advanced a lawsuit against FDA deregulation after the Supreme Court in June 2024 dismissed a pro-life doctors' case for lack of standing, without addressing the rollback's legality.
As these developments unfold, the attorneys general's push reminds us that true progress means safeguarding health without succumbing to woke pressures that downplay risks to fit narratives.