Tags: fda | mifepristone | marty makary | josh hawley

FDA's Makary Says Agency Will Review Mifepristone

By    |   Tuesday, 03 June 2025 05:25 PM EDT

Food and Drug Administration Commissioner Marty Makary has reportedly committed to investigating the safety of the abortion drug mifepristone, according to The Hill.

In a letter, Makary told Sen. Josh Hawley, R-Mo., that the "FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy."

"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," he wrote, according to The Hill.

Access to the abortion drug is the subject of ongoing litigation and Makary reportedly did not go into further detail about the FDA review.

In April, Hawley sent a letter to Makary, urging him to review new data on mifepristone and "take all appropriate action to restore critical safeguards" on its use.

The Missouri senator also criticized Makary's statement that he had "no plans to take action" on mifepristone, while reminding the commissioner that he pledged to "review the totality of the data and ongoing data" during his confirmation hearing.

The data Hawley referenced in his letter comes from a study of more than 865,000 prescribed mifepristone abortions published by the Ethics and Public Policy Center in April. The conservative think tank's stated mission is to "push back against the extreme progressive agenda."

According to the study's findings, nearly 11% of women who use mifepristone to induce an abortion experience "sepsis, infection, hemorrhaging, an emergency room visit, or another serious adverse event within 45 days."

The Hill reported that the study Hawley cited has a much higher rate of serious adverse reactions than other clinical studies, which determined the rate to be 0.5%. The database where the insurance claims that were used were obtained is also not clearly identified, according to the outlet.

Mifepristone was first approved by the FDA as an abortion-inducing medication in 2000, along with companion drug misoprostol.

According to data from reproductive rights group the Guttmacher Institute, 63% of U.S. clinician-provided abortions in 2023 were medication abortions, which do not need to take place in a clinic. Patients can pick up the medications at an abortion clinic and take them home or opt to receive the two-drug regimen in the mail.

Last year, the Supreme Court dismissed a lawsuit filed against the FDA by a group of anti-abortion activists and doctors, which challenged the agency's approval of mifepristone. But in January, a Texas federal judge ruled that three Republican-led states – Idaho, Kansas and Missouri – could intervene and move forward with the case, which aims to restrict access to the abortion drug.

Nicole Weatherholtz

Nicole Weatherholtz, a Newsmax general assignment reporter covers news, politics, and culture. She is a National Newspaper Association award-winning journalist.

© 2025 Newsmax. All rights reserved.


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Food and Drug Administration Commissioner Marty Makary has reportedly committed to investigating the safety of the abortion drug mifepristone, according to The Hill.
fda, mifepristone, marty makary, josh hawley
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2025-25-03
Tuesday, 03 June 2025 05:25 PM
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