Investigation Launched on Abortion Drug Mifepristone
Robert F. Kennedy Jr., who heads the Department of Health and Human Services (HHS), has initiated an inquiry into the potential risks associated with the abortion drug mifepristone.
In a letter dated September 19, addressed to 22 Republican attorneys general, both Kennedy and FDA Commissioner Marty McCurry indicated that the FDA is undertaking a “unique review” of available evidence, focusing on real-world outcomes and the drug’s safety and efficacy.
Back in July, the FDA was prompted to reassess the safety of abortion medications. It seems mifepristone has gained traction in various states, particularly those imposing restrictions—two-thirds of abortions now utilize this method.
In their correspondence, Kennedy and McCurry wrote, “Concerns raised during your review are closely considered. This administration is committed to ensuring women’s health is safeguarded through a comprehensive investigation into the safe distribution of mifepristone.”
They noted that this review was triggered by questions surrounding prior considerations involved in the approval process of the Risk Evaluation and Mitigation Strategy (REMS). Recent studies, they pointed out, have cast doubt on the safety of mifepristone, which is widely used today.
One study by the Center for Ethics and Public Policy looked into insurance data and revealed that nearly 11% of patients reported “serious adverse events,” contrasting sharply with the 0.5% rate declared on the drug’s label. These events included issues like bleeding and sepsis.
A separate peer-reviewed study, which was not mentioned by Kennedy, argued there’s no strong scientific support for frequent concerns raised. In fact, it claimed that mifepristone is safer than commonly used medications like Tylenol.
“HHS is dedicated to investigating the reported adverse effects associated with mifepristone. This is crucial to ensuring that REM remains adequate for protecting women from unforeseen risks,” Kennedy and McCurry remarked.
Under the Biden administration, the requirements for obtaining abortion pills have been notably eased. The FDA eliminated face-to-face dispensing mandates for these medications in 2023. Furthermore, the Supreme Court dismissed a challenge to these FDA regulations in 2024, deciding the plaintiffs lacked a strong legal standing.
A recent investigation revealed that five online abortion providers were dispensing pills for “future use” without adequately verifying key medical information, such as the stage of pregnancy. This raises further concerns about the safety and regulatory oversight in the distribution of abortion medications.
