Pro-life advocates are calling for action as top federal health officials deny reports that they are delaying a promised safety review of the abortion pill. / Credit: Yta23/Shutterstock
CNA Staff, Dec 10, 2025 / 18:30 pm (CNA).
Pro-life advocates are calling for action as top federal health officials deny reports that they are delaying a promised safety review of the abortion pill.
The Food and Drug Administration (FDA), an agency of the U.S. Department of Health and Human Services, “has delayed a promised review of safety data” until after midterm elections at Commissioner Marty Makary’s request, a Tuesday report by Bloomberg Law claimed, citing unnamed sources.
The U.S. Department of Health and Human Services (HHS) has denied the claim, saying it is “baseless.”
“Assertions that the FDA is slow walking this review for political purposes are baseless,” an HHS spokesperson told CNA.
“FDA takes the time necessary to conduct comprehensive scientific reviews, and that is what Dr. Makary is ensuring as part of the Department’s commitment to gold-standard science and evidence-based reviews,” the statement continued.
In response, Republican Sen. Josh Hawley of Missouri — an outspoken advocate for reviewing abortion pill safety regulations — called the FDA’s actions “unacceptable.”
In a letter addressed to Makary, Hawley urged the FDA to conduct a safety review and reinstate safety regulations that were removed during the pandemic under the Biden administration.
“It is unclear whether you are conducting an independent safety review at all,” Hawley said in the Dec. 10 letter. “I cannot emphasize enough the danger of playing politics with women’s health.”
In June of this year, Makary told Hawley that he would conduct a review of the abortion drug. In May, HHS Secretary Robert F. Kennedy Jr. also said the FDA would do a review of the drug.
Since then, the FDA has not completed a safety review, but has approved a generic version of the abortion drug mifepristone.
“There are more abortions in America now than when Roe was still law,” Hawley said in the letter.
Pro-life advocates are demanding action from the FDA, saying the issue is urgent because of the lives that are at risk given the danger of mail-order prescriptions of the drug.
Two recent, peer-reviewed studies found that one in 10 women experience serious adverse reactions after having a chemical abortion.
FDA regulations allow abortion pills to be shipped to patients without a telehealth visit. Multiple cases have been reported where the father of the unborn child has allegedly coerced or poisoned the mother with the abortion drug.
“The FDA must act NOW to protect children and their mothers,” said Lila Rose, founder of Live Action.
Susan B. Anthony Pro-Life America President Marjorie Dannenfelser has called for Makary to be fired, saying he is “undermining President Trump and Vice President Vance’s pro-life credentials and their position that states should have the right to enact and enforce pro-life protections.”
“The FDA is doing nothing while every single day abortion drugs take the lives of children, put women and girls at serious risk, empower abusers and trample state pro-life laws,” Dannenfelser said in a Dec. 9 statement shared with CNA.
Dr. Christina Francis, head of the American Association of Pro Life OBGYNs (AAPLOG) called on the FDA to review the drug immediately and to reinstate safeguards around the drug.
“We are tired of empty promises,” Francis said in a statement. “Women’s health matters more than political elections.”
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