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Debatable: Mifepristone review

Morgan Chalfant
Morgan Chalfant
Deputy Washington editor, Semafor
Updated Dec 19, 2025, 5:21am EST
Politics
FDA Commissioner Marty Makary at a press conference
Elizabeth Frantz/Reuters
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what’s at stake

The Trump administration’s handling of the abortion drug mifepristone is dividing the Republican Party.

Bloomberg reported this month that FDA Commissioner Marty Makary is slow-walking the administration’s promised safety review of the approved abortion drug for political reasons, looking to put it off until next year’s midterm elections.

A White House official denied to Semafor that the review is being delayed, noting that “comprehensive and exhaustive reviews take time.” Still, the report — as well as the lack of public action by the FDA — has led conservative abortion opponents to call for Makary’s ouster.

They include former Vice President Mike Pence, who this week also called for the firing of HHS Secretary Robert F. Kennedy Jr. over the lack of action on the drug, which is widely viewed as safe by physicians.

HHS did not return a request for comment for this story.

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who’s making the case

Marjorie Dannenfelser, president of the anti-abortion organization Susan B. Anthony Pro-Life America, argues that Makary should be removed from his position due to the FDA’s failure to place restrictions on the drug:

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“For months, we have urged the FDA to end Biden’s COVID-era abortion drug policy and the restore in-person doctor visits required under President Trump. That demand is echoed by 22 attorneys general, 51 senators, and 175 members of the House.

“By allowing abortion drugs to be shipped by mail without screening, the Biden administration stripped away common-sense safeguards that exist for countless other high-risk drugs. The consequences are real. Women are coming forward after being poisoned by abusers. In Ohio, a medical resident was criminally indicted for forcing these drugs into his pregnant girlfriend’s mouth, sending her to the ER and killing her baby. Unfortunately, this case is not isolated. Unfettered abortion drugs by mail are creating a tragic public health crisis.

“Voters see the danger. Seven in ten agree this policy is radical and unsafe, including many who are ‘pro-choice.’ Yet the FDA has failed to act. The promised safety study has reportedly not even begun, a new generic abortion drug was just recklessly approved and mail-order abortions increased 40% this year.

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“This is a failure of leadership. Every day this policy continues, women are put at risk, unborn children die and abusers are empowered. Enough is enough.”

Sen. Ron Johnson, R-Wis., who was among the lawmakers who signed on to a letter urging the FDA to rethink its approval of a generic version of mifepristone, voiced disagreement with calls for the commissioner’s ouster:

“I am not going to tell the secretary how to run his agency. I am a big supporter of the secretary and he’s got a tough job.”

White House spokesman Kush Desai made clear that Makary has the full backing of the president:

“FDA Commissioner Marty Makary is working diligently to ensure that Americans have the best possible, Gold Standard Science study of mifepristone. The White House maintains the utmost confidence in Commissioner Makary, whose leadership at the FDA has delivered and continues to deliver one landmark victory for the American people after another, from cracking down on artificial ingredients in our food supply to conducting the first safety review of baby formula in decades.

“Uninformed attacks against Commissioner Makary from individuals outside the administration will not change these facts.”

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Notable

  • A coalition of anti-abortion groups wrote to President Donald Trump earlier this week expressing “deep concernabout the FDA’s actions with respect to mifepristone.
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