Sen. Josh Hawley, R-Mo., is demanding answers from Food and Drug Administration Commissioner Dr. Marty Makary after he declined to give The Daily Signal a time frame for his review on the abortion pill.
“Yesterday, in response to the latest reports, you said, ‘There has been an ongoing review of mifepristone. It’s actually required as part of a policy called REMS,’” Hawley wrote, linking to The Daily Signal interview. “But that is not what you promised. You promised a new and comprehensive study taking account of all available safety data, not the standard monitoring FDA already performs for countless drugs.”
Makary told The Daily Signal Tuesday that the review of the abortion drug mifepristone is in the “data acquisition phase,†following a Bloomberg report saying he is delaying the process until after midterms.
“We do an ongoing review, but we’re also engaging in a robust study that can serve to validate or not validate other numbers that have been put out there in the literature,†the FDA chief said.
Makary and Secretary of Health and Human Services Robert F. Kennedy Jr. have pledged to do a review of the safety of abortion drugs. But Hawley said it is unclear if Makary is “conducting an independent safety review at all.”
“This is totally unacceptable,” the senator wrote. “I cannot emphasize enough the danger of playing politics with women’s health.”
The Ethics & Public Police Center study found that about 11% of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion. This has led to calls to reinstate the in-person dispensing requirement for mifepristone.
“The safety regulations from President [Donald] Trump’s first term should be reinstated,” Hawley said. “But you have not done so. And news reports indicate you are attempting to sideline any review of mifepristone safety.”
In response to Hawley’s letter, HHS press secretary Emily Hilliard said, “FDA’s comprehensive scientific reviews take the time necessary to get the science right, and that is what Dr. Makary is ensuring as part of the Department’s commitment to gold-standard science and evidence-based reviews.”
Hawley demanded direct answers on what the FDA is doing regarding the safety review.
“Is the FDA conducting a comprehensive safety review of mifepristone separate from the REMS process?” Hawley asked, specifying that the answer should include when the study began and a specific timeline for its completion.
“If you are conducting a comprehensive safety review, did you order it to be delayed? Why? Until when?” Hawley asked.
When questioned by The Daily Signal about the timeline of the review, Makary said he is unable to predict the “results or the timeframe†of it.
“The shutdown was a little bit of a setback in that, but we’re gonna do it and whenever the results are available,†he said, “we’re gonna make them public.â€
Hawley also asked if the FDA has plans to update the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) “to restore basic safety guardrails from President Trump’s first term, such as in-person dispensing.”
When asked by The Daily Signal if it’s safe for women to take the abortion pill at home without seeing a doctor first, Makary said the Ethics & Public Police Center study “was done in claims data, so it didn’t have granularity into the patient characteristics in a way that many researchers would want to have.â€
He dismissed the report that he is delaying the review of the abortion pill as a rumor circulating on social media.
“There’s a lot of rumors that are circulating out there,†he said. “We live in a very partisan time, and so you’re going to see the echo chambers of social media sort of magnify rumors, things that are just not true. There has been an ongoing review of mifepristone.â€
Susan B. Anthony Pro-Life America said “the reality is far worse” than a social media rumor.
“Now, nearly a year into the Trump administration, the Dr. Makary abortion drug safety review hasn’t even passed the data-gathering phase and there’s no ETA,” the organization wrote on X in response to The Daily Signal’s interview. “That’s the definition of slow-walking.”
“We repeat: Makary must go,” the leading pro-life organization said.
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