Health and Human Services Secretary Robert F. Kennedy Jr. has initiated a thorough investigation into the potential risks associated with the abortion medication mifepristone.
This development was confirmed by the Daily Caller News Foundation on Thursday. The inquiry comes in response to growing concerns about the drug's safety and efficacy, particularly as it becomes more prevalent in abortion procedures across the United States.
In a letter addressed to 22 Republican attorneys general on September 19, Kennedy, alongside Food and Drug Administration Commissioner Marty Makary, indicated that the FDA is undertaking a comprehensive review of the existing evidence. This includes real-world outcomes and data concerning the safety and effectiveness of mifepristone.
According to the Daily Caller, the attorneys general had previously urged the FDA in July to reevaluate the safety profile of the abortion pill, which now accounts for nearly two-thirds of all abortions annually, even in states with restrictive abortion laws.
Kennedy and Makary emphasized the importance of the investigation, stating, "The concerns you have raised in your letter merit close examination. This Administration will ensure that womens health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed."
This statement underscores the administration's commitment to safeguarding women's health by scrutinizing the conditions under which the drug is administered.
The impetus for this review stems from what Kennedy and Makary describe as "the lack of adequate consideration underlying the prior [Risk Evaluation and Mitigation Strategy (REMS)] approvals," as well as recent studies that have raised alarms about the drug's safety.
One such study, conducted by the Ethics and Public Policy Center, revealed that nearly 11% of patients experienced a "serious adverse event" after taking mifepristone. These events included severe complications such as hemorrhaging, sepsis, fallopian tube rupture, and infection, a stark contrast to the 0.5% adverse event rate listed on the drug's label.
Moreover, a separate peer-reviewed study, although not cited by Kennedy, challenged the common assertion that mifepristone is safer than Tylenol, suggesting there is no scientifically valid basis for such a claim. Kennedy and Makary reiterated the HHS's dedication to examining the adverse effects associated with mifepristone, stating, "HHS is committed to studying the adverse consequences reported in relation to mifepristone to ensure the REMS are sufficient to protect women from unstated risks."
The regulatory landscape for obtaining mifepristone has shifted significantly under the Biden administration. In 2023, the FDA permanently removed the requirement for in-person dispensing of the abortion pill. The Supreme Court, in 2024, dismissed a legal challenge to these regulations from doctors and pro-life medical associations, citing a lack of standing to sue.
A separate investigation by the Daily Caller News Foundation in June uncovered that five online abortion providers were distributing pills for "future use" without verifying essential medical information, such as the stage of pregnancy. This revelation further underscores the need for a rigorous review of the drug's safety protocols to ensure the protection of women's health.
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