At least two Senate Republicans are accusing the Food and Drug Administration of dragging its feet on a promised safety review of the abortion pill mifepristone, raising the prospect of congressional action to curb access to the drug.

The criticism came after a closed-door briefing Tuesday with FDA Commissioner Marty Makary, according to reports.

Sen. Josh Hawley, R-Mo., said Makary failed to provide basic details about the review, including when it would be completed, what it would examine or whether it is underway.

"I think that this safety study is a dead end," Hawley said, according to Politico. "I just think that FDA is not serious about it. I don't think that they're proceeding with any sense of urgency whatsoever. If they're really proceeding at all. I frankly, can't tell."

Hawley added that he has "lost confidence" in Makary's leadership and told reporters he was "really disappointed" with the briefing.

"I don't think he's serious about it," Hawley told Semafor.

Sen. Bill Cassidy, R-La., chairman of the Senate Health, Education, Labor and Pensions Committee, organized the session and echoed the frustration.

In a statement, Cassidy criticized "the lack of progress on HHS and FDA's promised safety study on these dangerous drugs" as "disappointing," saying the review is "moving too slowly."

Makary previously committed to examining mifepristone's safety after initially signaling he would not revisit the issue.

The drug's safety profile has been studied extensively, but Republicans argue that Biden-era changes expanding access — including mail distribution and telemedicine prescriptions — warrant further scrutiny.

An HHS spokesperson defended the agency's process, stating that the FDA "is taking care to do this study properly and in the right way."

"We are planning to complete the study as soon as possible while ensuring we are not cutting any corners from a scientific research standpoint," a previous statement read, adding that such reviews "often take approximately a year or more to conduct."

Mifepristone is used in more than two-thirds of abortions nationwide. Previous Republican efforts to restrict the drug through appropriations bills have failed.

Hawley said he has not decided whether to pursue limits through upcoming funding legislation or introduce a standalone bill but indicated plans are coming soon.

"I don't have confidence [the FDA review] is going to amount to anything," he said. "My view is Congress now needs to get involved."

Several GOP-led states, including Missouri and Louisiana, are also suing the FDA over its abortion pill policies as pressure builds within conservative circles for tougher action.

• WH Backs FDA Chief Makary After Anti-Abortion Groups Demand His Firing
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