FDA Chief Commits To Full Review Of Abortion Pill

FDA Commissioner Marty Makary has committed to reviewing the abortion pill’s safety, according to Sen. Josh Hawley (R-MO).

Hawley posted a letter he received from Makary on social media, noting the FDA head promised to review the safety of mifepristone, the popular abortion drug.

“As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the Agency who review this data,” Makary wrote in his letter to Hawley.

FDA chief Marty Makary just committed to me to do a full review of the chemical abortion drug’s safety: “As Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone” 👇 pic.twitter.com/nMxUhE18UA

— Josh Hawley (@HawleyMO) June 3, 2025

“As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy,” Makary wrote.

Makary also noted that mifepristone is currently enmeshed in legal battles.

“FDA generally does not comment on matters that are the subject of pending litigation and therefore is unable to provide further information on this topic at this time,” the FDA chief said.

“FDA is committed to safeguarding public health by ensuring the safety, efficacy, and quality of the products it regulates,” Makary wrote. “The Agency carefully evaluates the scientific data, leveraging rigorous science to make informed decisions.”

The two-pill chemical abortion regimen — mifepristone, usually followed by misoprostol — aims to end the life of the unborn baby and expel it from the woman’s uterus. However, the drugs sometimes fail to expel all the fetal tissue, which can cause life-threatening complications.

An analysis released in April found that more than one in 10 women experienced a “serious adverse event” after taking the mifepristone abortion pill in 2023. This can include hemorrhaging, needing a blood transfusion, an emergency room visit, and even deadly conditions like sepsis.

That is about 22 times higher than what the FDA listed on its label for the brand Mifeprex in 2023. The FDA cited clinical studies saying less than 0.5% of women suffered “serious adverse reactions” to mifepristone.

Meanwhile, more than one in 20 women need a second abortion attempt after the abortion pill fails, another analysis of insurance claim data released this week showed.

Last month, Robert F. Kennedy Jr., head of the Department of Health and Human Services, told lawmakers he had requested the FDA do a “complete review” of the abortion pill in the wake of the new data.

“It’s alarming,” RFK Jr. told Hawley during a Senate committee hearing.

“Clearly, it indicates that at the very least the label should be changed,” he said. “I’ve asked Marty Makary, who’s the director of the FDA, to do a complete review and to report back.”

A few months before Roe v. Wade was overturned, the FDA scrapped the requirement that women must obtain abortion pills in person from a healthcare provider, allowing them to get them online through the mail.