The majority of Republican senators on Thursday called on Health and Human Services Secretary Robert F. Kennedy Jr. to reconsider the approval of a new generic version of the abortion pill mifepristone.
Fifty GOP senators signed on to a letter written by Sen. Lindsey Graham (R-SC) calling on Kennedy and Food and Drug Administration Commissioner Marty Makary to “take decisive action to reevaluate whether this generic version of mifepristone is suitable to enter the market.”
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“We are committed to continuing to work together to give a voice to the voiceless and protect women from the dangerous effects of unregulated access to chemical abortion drugs. The life, safety, freedom, and health of millions of Americans, born and unborn, depend on it,” the letter said.
It was signed by all the Republican senators except Sens. Susan Collins (R-ME) and Lisa Murkowski (R-AK).
Republican senators have expressed anger after the FDA granted approval for the company Evita Solutions to start producing a second generic formulation of the abortion drug mifepristone, the pill used in roughly two-thirds of all abortions in the United States.
Mifepristone, which was approved by the FDA in 2000, is a progesterone blocker that effectively prevents nutrients from reaching a developing fetus. A secondary agent, misoprostol, is used 24 to 48 hours after taking mifepristone to induce contractions to expel pregnancy tissue.
Opponents of the pill say the FDA’s decision in 2016 to no longer require physicians to report nonfatal adverse complications has led to skewed safety statistics for the drug. They also argue that removing in-person screening requirements for dispensing mifepristone endangers women, as ultrasounds are necessary to determine the gestational age of the fetus and to ensure the abortion is complete.
During their respective Senate confirmation hearings, Kennedy and Makary said President Donald Trump was interested in the FDA performing a post-market safety review of mifepristone following a report by the anti-abortion Ethics and Public Policy Center that nearly 11% of women prescribed mifepristone experience possibly life-threatening complications within 45 days of a medication abortion.
After HHS and the FDA received pushback following the news of the generic approval, HHS spokesman Andrew Nixon told reporters that the agency is statutorily required to approve generic drugs if they are the same chemical formula as the original product and that HHS is not allowed to ask the manufacturer for new information, including safety data.
However, the GOP senators wrote that they “are deeply concerned” about the timing of the approval.
“While we recognize the FDA’s statutory responsibility in evaluating drug applications, the timing of this approval appears inconsistent with the comprehensive safety reassessment your agencies have prioritized,” the senators wrote.
When asked about the letter, White House spokesman Kush Desai told the Washington Examiner that the FDA is “very limited in deciding whether to approve a generic drug, and the FDA’s approval of a generic mifepristone is not an endorsement of the product.”
The quiet approval of the new generic version of the drug has led some conservatives to question whether Kennedy and Makary are indeed conducting a safety review of the abortion drug.
Sen. Josh Hawley (R-MO), who also signed on to Graham’s letter, told the Washington Examiner last week that he believes he was “misled” by Makary during his confirmation hearing about his commitment to a review of safety data on mifepristone.
In their letter, the senators asked Kennedy and Makary to suspend the approval of the new generic mifepristone and commit to re-instituting in-person screening requirements, which were removed during the COVID-19 pandemic under the Biden administration.
“President Biden used the COVID-19 pandemic as a pretext to remove these critical safeguards and fundamentally undermine women’s reproductive health. But in November 2024, seventy-three million Americans voted to bring a stop to this radical abortion agenda,” the Republicans wrote.
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Desai said in a statement that, “By law, the FDA is very limited in deciding whether to approve a generic drug, and the FDA’s approval of a generic mifepristone is not an endorsement of the product. HHS remains committed to its study of the reported adverse effects of mifepristone.”
Evita Solutions did not respond to the Washington Examiner‘s request for comment.