Kennedy Says FDA Reviewing Safety of Abortion Pill Mifepristone

Key Takeaways

• The U.S. Food and Drug Administration is conducting a safety review of the abortion pill mifepristone

• The review comes after conservative and anti-abortion groups raised concerns about the drug and access to it

• The review may alter how the drug is prescribed, but an outright ban is unlikely

MONDAY, Sept. 29, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) is reviewing the safety of mifepristone, a drug used in medication abortions for 25 years, amid a push from conservative state attorneys general and anti-abortion groups. 

The announcement was made in a letter from Health and Human Services Secretary Robert F. Kennedy Jr, according to CBS News.

The review, spearheaded by Kennedy, focuses on compliance with an FDA safety program aimed at ensuring a drug’s benefits outweigh its risks. He said it will review “the latest data” and "real-world outcomes and evidence" related to the drug's safety and effectiveness.

The review follows action in 2023 by the Biden administration allowing patients to receive mifepristone by mail and through telehealth appointments. Conservatives have criticized the move. A majority of abortions in the U.S. are now done using medication, with mifepristone being the first of a two-drug regimen.

The letter from Kennedy cited a study by the Ethics and Public Policy Center (EPPC) that suggested "potential dangers that may attend offering mifepristone without sufficient medical support or supervision." The letter also mentioned FDA data, which reported 2,740 adverse events from 2000 to 2012, including 416 requiring blood transfusions, CBS News reports. 

The EPPC study said nearly 11% of women experience a serious adverse event. Other sources contest that figure.

"Other data sources show the rate of serious complications to be much lower, at less than 1 in 200," CBS News medical contributor Dr. Céline Gounder said.

Advocates for the drug’s use insist it has a strong safety record. 

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"More than 100 studies confirm mifepristone's exceptional safety record," the American Civil Liberties Union (ACLU) said in a statement. It noted that the drug has been used by more than 7.5 million women since its initial FDA approval in 2000. It is approved to terminate pregnancy through 10 weeks of gestation.

While the review could lead to changes in how the drug is prescribed, such as limiting its availability through telehealth or to certain types of health care providers, experts suggest an outright ban is unlikely. 

Gounder said it would be "an extraordinary step" for the FDA to withdraw its approval for mifepristone and would likely face immediate legal challenges.

While Kennedy's letter did not provide a timeline for completion of the review, he said the FDA would keep states informed of its progress.

More information

The U.S. National Library of Medicine has more information about mifepristone.

SOURCES: CBS News, Sept. 26, 2025 

What This Means For You

The outcome of this federal government review could affect how and where women can access mifepristone for a medication abortion or for miscarriage care.