The Food and Drug Administration will conduct a review of the abortion pill mifepristone following intense pressure from Sen. Josh Hawley (R-MO) and anti-abortion advocates to review updated safety information for medication abortions.
FDA Commissioner Marty Makary wrote in a letter to Hawley on Monday that he is “committed to conducting a review of mifepristone and working with professional career scientists at the agency who review this data.”
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The review comes after Hawley and anti-abortion groups slammed Makary in April after he said he had “no plans to take action” regarding FDA regulations on mifepristone that have allowed healthcare providers to ship the abortifacient to patients in other states, irrespective of state laws prohibiting elective abortions.
FDA regulations on mifepristone, the first medication involved in the two-part medication abortion protocol, have been a flashpoint in the abortion debate since the 2022 Dobbs v. Jackson Women’s Health Organization decision, which overturned federal protections for abortion.
In a medication abortion, mifepristone blocks the hormone progesterone, which is necessary for fetal development. Up to 48 hours after taking mifepristone, the drug misoprostol is used to induce contractions to expel the fetal remains and other pregnancy tissue.
In 2016, the FDA loosened safety regulations on mifepristone, allowing it to be used to terminate pregnancies up to 10 weeks of gestation, and it no longer required that doctors report complications other than death.
During the COVID-19 pandemic, the Biden administration’s FDA removed in-person screening requirements for patients to obtain the medication, allowing healthcare providers to ship mifepristone to patients without a physical consultation.
Mifepristone is used in nearly two-thirds of abortions in the United States, according to the Guttmacher Institute, the research arm of Planned Parenthood Federation of America.
Being able to mail mifepristone to patients is credited as one of the reasons the number of abortions in the U.S. has increased post-Dobbs, even in states that have banned elective abortions.
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But a new study from the Ethics and Public Policy Center, a think tank that is opposed to abortion, used public and private health insurance data to find that the rate of severe complications from mifepristone abortions is 22 times higher than FDA data indicate.
The EPPC study found that more than 1 in 10 women may experience serious or possibly life-threatening complications, such as hemorrhaging or sepsis, from medication abortions.
In his letter to Hawley, Makary did not provide a time frame for when the review would occur or what data would be included in the agency’s review, saying that the litigation from anti-abortion groups against the FDA limits the extent of his public comments.
Hawley’s wife, Erin Morrow Hawley, argued before the Supreme Court last year against the Biden administration’s FDA on behalf of her legal advocacy firm Alliance Defending Freedom in an attempt to persuade the court that the FDA had overstepped its authority in deregulating the drug.
The Supreme Court dismissed the case due to its lack of legal standing, but ADF is continuing to litigate the merits of the case on behalf of several states.
When asked for comment, Hawley’s office did not provide more context for the Washington Examiner other than the letter.