Robert F. Kennedy Jr., is using his role as United States Health and Human Services Secretary to put an abortion drug back in the spotlight. He and Food and Drug Administration Commissioner Marty Makary announced a new safety review of mifepristone, the pill most commonly used for abortions, in a letter to Republican attorneys general dated Sept. 19.
Kennedy orders safety review
The review will examine whether the medication’s current guidelines remain safe or need adjustments, signaling a potential shift in how one of the country’s most widely used reproductive drugs is regulated. It could also change the way mifepristone is dispensed and prescribed.
Today, patients can access mifepristone through telehealth appointments and have the medication delivered by mail. Critics of abortion rights argue that this approach bypasses state-level abortion restrictions. Medication has become the most common method for abortions in the United States, accounting for 63% of all procedures in 2023, according to the Guttmacher Institute.
According to ABC News, the letter cited concerns from 22 state attorneys general as a reason for reviewing mifepristone.
“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 said.
Attorneys general cite new study
The attorneys general’s appeal references a study by the Ethics and Public Policy Center that reviewed 865,727 mifepristone prescriptions from 2017 through 2023 using an all-payer insurance database, which collects claims from both private and public insurers.
The study was not peer-reviewed and was conducted by the EPPC, a conservative organization that seeks to apply Christian and Jewish traditions to law, culture and public policy.
The research found that 10.93% of women experienced serious complications, including sepsis, infections or hemorrhaging, within 45 days of taking the medication, compared with the 0.5% rate listed 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,” the attorneys general wrote.
Planned Parenthood Action Fund criticized Kennedy’s move, saying it dismisses evidence-based public health at a critical time. The organization also argued that the decision overlooks the broader reproductive health services people depend on.
In a sharper statement, the group said, “This isn’t an exaggeration: What RFK Jr. doesn’t know about public health science could kill you.”
The letter urged the FDA to restore 2011-era safety regulations removed under prior administrations. It also recommends that, if the FDA cannot reinstate these safeguards, that they consider withdrawing mifepristone from the market until a full review of safety and efficacy can be completed.
What is mifepristone?
Mifepristone, often paired with another drug called misoprostol, is designed to end a pregnancy up to 10 weeks gestation, according to the FDA. The pill works by blocking progesterone, a hormone essential for maintaining pregnancy. Typically, patients take 200 mg of mifepristone by mouth on the first day, followed 24 to 48 hours later by 800 mcg of misoprostol in a cheek pouch.
The FDA first approved Mifeprex, the brand-name version of mifepristone, in 2000 for pregnancies up to seven weeks and extended approval to 10 weeks in 2016. A generic version was approved in 2019 and is considered therapeutically equivalent.
The agency said both the original and generic products are safe when used as directed under the Mifepristone Risk Evaluation and Mitigation Strategy program.
The FDA says the agency monitors reports of serious adverse events, and as of Dec. 31, 2024, there have been 36 deaths reported since approval, though causal links to the drug are uncertain.
The FDA emphasized that while mifepristone is associated with risks like sepsis, hemorrhaging or complications from ectopic pregnancies, it continues to be approved for use under strict guidelines, and health care providers are advised to follow labeling and monitor patients closely.
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