Health and Human Services Secretary Robert F. Kennedy Jr. has launched an investigation into the risks of the abortion drug mifepristone, the Daily Caller News Foundation confirmed.

In a letter to 22 Republican attorneys general dated recently, reviewed by the DCNF, Kennedy and Food and Drug Administration Commissioner Marty Makary said the FDA is conducting “its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug.”

The attorneys general had urged the FDA earlier this year to reassess the safety of the abortion pill, which now accounts for nearly two-thirds of abortions annually and is increasingly common even in states with restrictions.

“The concerns you have raised in your letter merit close examination. This Administration will ensure that women’s health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed,” Kennedy and Makary wrote.

They added that the review was prompted by “the lack of adequate consideration underlying the prior [Risk Evaluation and Mitigation Strategy] approvals, and by recent studies raising concerns about the safety of mifepristone as currently administered.”

One such study, conducted by the Ethics and Public Policy Center, analyzed insurance data and found nearly 11% of patients reported a “serious adverse event” after taking the abortion pill — including hemorrhaging, sepsis, fallopian tube rupture, and infection — compared to the 0.5% rate listed on the drug label.

A separate peer-reviewed study concluded there is no scientifically valid basis for the oft-repeated claim that mifepristone is safer than Tylenol.

“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. Therefore, through the FDA, HHS will conduct a study of the safety of the current REMS, in order to determine whether modifications are necessary,” Kennedy and Makary added.

The requirements for obtaining the abortion drug were significantly reduced under the Biden administration, with the FDA permanently eliminating an in-person dispensing requirement for the abortion pill in 2023.

The Supreme Court dismissed a challenge to the FDA’s regulations brought by doctors and pro-life medical associations in 2024, finding they lacked standing to sue.

During a DCNF investigation earlier this year, five online abortion providers supplied pills for “future use” without a doctor verifying key medical information, like the stage of pregnancy.

The investigation represents a major shift from Biden administration policies that loosened access restrictions for mifepristone.

Kennedy’s focus on drug safety reflects the Trump administration’s commitment to rigorous review of pharmaceutical approvals.

The dramatic difference between reported adverse events (11%) and the official drug label rate (0.5%) raises serious questions about data accuracy.

Studies showing mifepristone may not be safer than Tylenol contradict years of public health messaging about the drug’s safety profile.

The elimination of in-person dispensing requirements under Biden removed important safety protocols and medical oversight.

Online providers dispensing pills without proper medical verification creates dangerous situations for women’s health.

The attorney generals’ concerns about inadequate safety review validation suggest previous approvals lacked thorough analysis.

Kennedy’s investigation could lead to significant changes in how mifepristone is regulated and dispensed.

The focus on “real-world outcomes” indicates the review will examine actual patient experiences rather than just clinical trial data.

This investigation aligns with RFK Jr.’s broader mission to scrutinize pharmaceutical safety and regulatory capture.

The Supreme Court’s dismissal of previous challenges means this administrative review represents the best path for addressing safety concerns.

The high percentage of serious adverse events reported in insurance data suggests underreporting in official statistics.

This review could restore important safety protocols that were removed during the previous administration.

The investigation demonstrates the Trump administration’s commitment to protecting women’s health through rigorous drug safety standards.