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EXCLUSIVE: More than 20 Republican attorneys general are demanding that the Trump administration reinstate safety protocols for the abortion drug mifepristone, saying it poses “serious risks to women.”
In a letter obtained by Fox News Digital, 22 attorneys general called on Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drugs Administration head Martin Makary to bring back safeguards for the pills that were scrapped by the Obama and Biden administrations.
“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 reads, citing studies published earlier this year by the Ethics and Public Policy Center (EPPA), a Washington, D.C.-based advocacy group.
The EPPA report claims the pill presents harm to women, causing 1 in 10 patients to experience a “serious adverse event,” including hemorrhage, emergency room visits and ectopic pregnancy.
FDA CHIEF HAS ‘NO PLANS’ FOR ABORTION PILL POLICY CHANGES BUT CONTINUES SAFETY REVIEW
The letter, led by Kansas Attorney General Kris Kobach, comes after Kennedy Jr. asked Makary to review the latest data on mifepristone and its safety.
“Based on that review, the FDA should consider reinstating safety protocols that it identified as necessary as recently as 2011 in its issuance of a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, but which were removed by the Obama and Biden administrations,” the letter reads, adding that the drug should be taken off the market if safeguards cannot be put in place.
“Alternatively, in light of the serious risks to women who are presently being prescribed this drug without crucial safeguards, and in the event the FDA is unable to reinstate the 2011 safety protocols for mifepristone, the FDA should consider withdrawing mifepristone from the market until it completes its review and can decide on a course of action based on objective safety and efficacy criteria,” the attorneys general wrote.
Sen. Josh Hawley, R-Mo., also sent a letter to Kennedy Jr. last month urging him to take immediate action to reinstate safety guardrails on mifepristone following the secretary’s commitment to conducting a safety review of the drug.
Makary had previously said that he had no plans to modify policies surrounding mifepristone but that the FDA would act if the data suggested there was a safety issue.
Mifepristone, which is taken with another drug called misoprostol to end an early pregnancy, was first approved by the FDA in 2000 after “a thorough and comprehensive review” found it was safe and effective, according to the agency’s website, which noted that periodic reviews since its approval have not identified new safety concerns.
Last year, the Supreme Court rejected a challenge targeting the drug’s availability. The plaintiffs had sought to restrict access to mifepristone across the country, including in Democrat-led states where abortion remains legal. The court did not rule on whether the FDA acted lawfully when it moved during the Obama and Biden administrations to ease the rules for mifepristone’s use that had been established during the Clinton administration.
Medication abortions made up more than half of all abortions in the U.S. health care system in 2023, according to a study by the Guttmacher Institute.
MEDICAL GROUPS URGE FDA, KENNEDY TO REEXAMINE BROAD APPROVAL OF ABORTION DRUGS
“Currently, a woman can obtain a mifepristone abortion by participating in only one telehealth visit with any approved healthcare provider (not necessarily a physician), ordering the drugs through a mail-order pharmacy, and self-administering them,” the attorneys general wrote. “And the prescriber is only required to report an adverse event if he or she becomes aware that the patient has died.”
“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 current FDA’s dedication to the health and wellbeing of all Americans is encouraging, as is the much-needed review of mifepristone that Secretary Kennedy has promised,” the letter concludes.
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