August 13, 2025
(Washington) – In a joint letter released this week, attorneys general from 22 states call on Health and Human Services Secretary Robert F. Kennedy Jr. and the Food and Drug Administration (FDA) to reinstate safeguards for the abortion pill, citing EPPC’s real-world study of the serious adverse effect rate of the drug.
This largest-known study of the abortion pill is based on analysis of data from an all-payer insurance claims database that includes 865,727 prescribed mifepristone abortions from 2017 to 2023. EPPC found that 10.93 percent of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion, an order of magnitude above the 0.5 percent claimed on the FDA label.
“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 from the attorneys general states.
The attorneys general called for the reinstatement of 2011-era safety regulations which were dismantled by the Obama and Biden administrations.
“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 letter continues.
“I’m thankful for the action of these attorneys general. Tragically, previous presidential administrations have watered down basic safety requirements for the abortion pill and American women have paid the price. We hope that the FDA will move swiftly to reinstate these safeguards and protect women.” – EPPC President Ryan T. Anderson
“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,” concludes the letter.
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Media Inquiries:
Hunter Estes
Director of Communications
Ethics and Public Policy Center
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