20 attorneys general demand safety review of abortion drug mifepristone

CNA Staff, Aug 13, 2025 / 14:49 pm (CNA).

A coalition of 22 attorneys general — all Republican — led by Kansas Attorney General Kris Kobach, has called on the Trump administration to reinstate safety protocols for the abortion drug mifepristone, citing severe risks to women’s health. 

In a letter addressed to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and Food and Drug Administration (FDA) Commissioner Martin Makary, the attorneys general urge Kennedy and Makary to restore safeguards removed by the Obama and Biden administrations or consider withdrawing the drug from the market.

The letter references a study published in April by the Ethics and Public Policy Center (EPPC), a Washington, D.C.-based advocacy group. The EPPC study claims mifepristone causes many more serious adverse events, including hemorrhage, sepsis, emergency room visits, and ectopic pregnancy, than stated on the drug’s label, which shows a less than .5% rate of adverse events.

“Recent comprehensive studies of the real-world effects of the chemical abortion drug mifepristone report that serious adverse events occur 22 times more often than stated on the drug’s label, while the drug is less than half as effective as claimed. These facts directly contradict the drug’s primary marketing message of ‘safe’ and ‘effective,’” the letter states.

The study, which examined 865,727 prescribed mifepristone abortions from 2017 to 2023, is the largest known study of the abortion pill. It found that 11% of women “experience at least one serious adverse event or repeated abortion attempt within 45 days of first attempting a mifepristone abortion.”

The attorneys general argue that the FDA should reinstate safety protocols from the 2011 Risk Evaluation and Mitigation Strategy, which required in-person prescriptions and provider follow-ups but were later relaxed by the Biden administration.

“The FDA’s removal of these crucial safety protocols in 2016 (and in 2023) that only five years before the FDA considered necessary begs the question of whether the removal was motivated by considerations other than the safety of patients,” the attorneys general wrote. “The current FDA’s dedication to the health and well-being of all Americans is encouraging, as is the much-needed review of mifepristone that Secretary Kennedy has promised.” 

The letter continues: “Currently, a woman can obtain a mifepristone abortion by participating in only one telehealth visit with any approved health care provider (not necessarily a physician), ordering the drugs through a mail-order pharmacy, and self-administering them. And the prescriber is only required to report an adverse event if he or she becomes aware that the patient has died.”

This push follows similar urging by U.S. Sen. Josh Hawley, R-Missouri, who, echoing the same EPPC findings, introduced the Restoring Safeguards for Dangerous Abortion Drugs Act in May. 

The bill would direct the FDA to create safeguards on mifepristone. It would also give women who have suffered complications from mifepristone the right to file lawsuits against telehealth providers and pharmacies. It would also prohibit foreign companies from importing and shipping the drug into the U.S.

Hawley urged immediate action to restore safety measures, and like the attorneys general, warned that without such measures, the FDA should consider removing mifepristone until the agency completes a thorough review.

When Hawley asked Kennedy if he was familiar with the study during a Senate Health, Education, Labor, and Pensions Committee hearing in May, Kennedy said he was. “It’s alarming, and clearly it indicates that, at very least, the label should be changed,” Kennedy said.

Kennedy also “pledged to conduct a top-to-bottom review of the drug,” Hawley said.

Also in May, a coalition of more than 100 pro-life groups, including various Catholic organizations, called for HHS to review the drug’s safety and restore previous federal safety regulations in light of the EPPC study.

Makary previously stated he had no plans to alter mifepristone policies unless data indicated a safety issue. The FDA, which first approved mifepristone in 2000 after a “thorough and comprehensive review,” maintains that periodic evaluations have not identified new safety concerns.

Mifepristone, used with misoprostol to terminate early pregnancies, accounted for 63% of U.S. abortions in 2023, according to the Guttmacher Institute. The number of actual abortions might be higher due to underreporting, according to the organization, which was affiliated with Planned Parenthood until 2007.

The Supreme Court rejected a challenge to mifepristone’s availability in 2024, declining to rule on the legality of relaxed regulations under the Obama and Biden administrations.

Source: https://www.catholicnewsagency.com/news/265931/20-attorneys-general-demand-safety-review-of-abortion-drug-mifepristone