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EXCLUSIVE: A coalition of 22 Republican attorneys general is urging for the reinstatement of critical safety measures for the abortion drug mifepristone, citing significant health risks to women. This demand targets the Biden administration and seeks a review of existing regulations originally established during the Obama era.
In a letter secured by Fox News Digital, the attorneys general addressed Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Chief Martin Makary, insisting that the safety protocols, previously eliminated, must be reinstated to protect women’s health.
The correspondence warns that extensive studies have shown that adverse effects related to mifepristone occur at rates 22 times higher than what the drug’s labeling suggests. Furthermore, the drug’s efficacy is claimed to be less than half of what was originally marketed. The letter references recent findings put forth by the Ethics and Public Policy Center, a Washington, D.C.-based advocacy organization.
According to the EPPA study, one in ten women taking the medication suffers from serious complications, which include hemorrhage, emergency room visits, and even ectopic pregnancies. These alarming statistics raise significant concerns about the drug’s safety profile.
The letter, spearheaded by Kansas Attorney General Kris Kobach, follows Kennedy Jr.’s initiative to request a fresh evaluation of mifepristone’s safety data from the FDA.
“Based on that review, the FDA should contemplate reinstating necessary safety protocols that it identified as crucial as recently as 2011 under a Risk Evaluation and Mitigation Strategy,” the attorneys general stated in the letter. They emphasized that if such protocols cannot be reintroduced, the drug should be withdrawn from the market entirely.
The letter outlined, “Alternatively, given the serious risks to women prescribed this drug without essential safeguards, if the FDA is unable to restore the 2011 safety protocols, it should consider removing mifepristone from distribution until it completes a thorough review.” This call reflects heightened scrutiny from state leaders regarding the safety of abortion drugs.
In a parallel action, Senator Josh Hawley of Missouri also contacted Secretary Kennedy last month, urging swift steps to restore safety regulations for mifepristone following the secretary’s commitment to reassess the drug’s safety.
Despite these pressures, Makary earlier indicated that while there are currently no plans to amend the existing mifepristone policies, the FDA would take action if presented with evidence of safety concerns.
Mifepristone, which is typically used alongside misoprostol to terminate an early pregnancy, was first approved by the FDA in 2000 after an extensive review established its safety and effectiveness. Periodic assessments since its approval have not revealed new safety issues, according to agency sources.
Last year, a Supreme Court decision upheld the drug’s continued availability, rejecting attempts to limit access to mifepristone, even in states where abortion remains legal. Notably, the court did not determine whether the FDA’s modifications during the previous administrations to ease mifepristone’s usage guidelines were lawful.
In the current healthcare landscape, medication abortions accounted for over half of all abortions in the United States in 2023, according to data from the Guttmacher Institute. This statistic underscores the significance of the ongoing debate surrounding mifepristone and its regulatory oversight.
The attorneys general expressed further concerns regarding the ease with which women can obtain a mifepristone abortion. They noted that current regulations permit access through a single telehealth appointment without requiring a doctor’s presence, allowing prescriptions to be filled via mail-order pharmacies while patients self-administer the medication. Alarmingly, prescribers are obligated to report adverse events only if they become aware of a patient’s death.
