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GOP Divides Over Mifepristone Safety Review as Critics Demand FDA Action

GOP Divides Over Mifepristone Safety Review as Critics Demand FDA Action

Summary: The Republican Party is divided over reports that FDA Commissioner Marty Makary has delayed a promised safety review of mifepristone for political reasons. The White House says the review is thorough and not intentionally delayed, while anti‑abortion leaders — backed by dozens of state attorneys general and members of Congress — press for restrictions and even the commissioner's removal. Supporters of Makary say he has presidential backing and that the review will be rigorous.

The Trump administration's handling of the abortion medication mifepristone has exposed a sharp rift within the Republican Party, with conservative activists and some lawmakers accusing the Food and Drug Administration (FDA) of stalling a promised safety review for political reasons.

Bloomberg reported this month that FDA Commissioner Marty Makary has been slow-walking the administration's pledged safety review of the approved drug, allegedly to avoid taking substantive action before next year's midterm elections. A White House official told Semafor that the review is not being delayed and that "comprehensive and exhaustive reviews take time."

Still, the Bloomberg report and the FDA's limited public activity on the matter have prompted renewed calls from anti-abortion leaders and some Republican figures for firings and stricter restrictions on the drug.

Former Vice President Mike Pence joined those urging action this week, and Marjorie Dannenfelser, president of Susan B. Anthony Pro‑Life America, publicly called for Makary's removal. HHS did not respond to a request for comment for this story.

Marjorie Dannenfelser: "For months, we have urged the FDA to end Biden's COVID-era abortion drug policy and restore the 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 administration stripped away safeguards that exist for many other high-risk drugs. We are hearing reports of women harmed by abusers, and a recent criminal case in Ohio involved a medical resident alleged to have forced these drugs into his pregnant girlfriend's mouth, sending her to the ER and causing a fetal death. Advocates say mail-order access has increased dramatically — Bloomberg cites a reported 40% rise this year — and that the FDA's promised safety study has not yet begun."

Not all Republicans support immediate disciplinary action against the commissioner. Sen. Ron Johnson (R-Wis.) — who signed a letter urging the FDA to reconsider the approval of a generic version of mifepristone — pushed back on calls to fire Makary: "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 emphasized presidential backing for Makary: "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." Desai added that attacks from outside the administration would not change those facts.

A coalition of anti-abortion groups also wrote to President Donald Trump earlier this week expressing "deep concern" about how the FDA is handling mifepristone. Advocates on both sides continue to cite studies and anecdotes to support their positions: many physicians and public-health experts regard mifepristone as safe when used as directed, while opponents argue that expanded mail-order access and the removal of in-person screening increase risks.

The dispute highlights a broader political and public-health debate over regulation, access, and the timing of safety reviews in the run-up to high-stakes elections.

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