FDA leader says he has no plan to act on abortion pill access

Food and Drug Administration Commissioner Marty Makary said he has no plans to change government policy on the abortion pill mifepristone, a hot-button issue in the U.S. since the Supreme Court overturned the landmark Roe v. Wade decision in 2022. 

Makary would reconsider the issue if new data emerged that signaled a safety issue with the drug that is now used in more than half of U.S. abortions, he said during an appearance at the Semafor World Economy Summit on Thursday.

While anti-abortion groups have sought to restrict access to mifepristone, the Supreme Court preserved full access to it in June 2024 when it rejected a ruling that would have barred mail-order prescriptions. It was approved for use by the FDA in 2000.

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Health and Human Services Secretary Robert F. Kennedy Jr. said in January that President Donald Trump asked him to investigate safety issues with mifepristone, which has been studied extensively. The FDA, which falls under the broader health agency, is ultimately responsible for policy on access to mifepristone.

Policy on the abortion pill was a flashpoint during Makary's confirmation process and Democratic senators pressed him on the issue. During his Senate hearing, Makary said he didn't have preconceived plans to act to restrict access to it, but he would review the data once he took office. 

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Mifepristone and access to the pill has been swept up in the U.S. court system in recent years. The FDA currently allows mifepristone to be prescribed through telehealth services, which has increased access to it. Missouri, Kansas and Idaho are suing the FDA to change that ruling for mifepristone, arguing that the pill can only be prescribed through in-person doctor's visits.

The suit, State of Missouri et al v. U.S. Food and Drug Administration et al, is ongoing and filed in a Texas court.