Some Senate Republicans emerged disappointed from a closed-door briefing Tuesday with FDA Commissioner Marty Makary, saying the agency is not taking a safety review of the abortion pill mifepristone seriously and calling for congressional action to curb access to the drug.
Sen. Josh Hawley (R-Mo.) said in an interview Makary failed to give a timeline for completion of the review, explain what the audit will involve and disclose whether it was even underway.
“I think that this safety study is a dead end,” Hawley said. “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.”
Sen. Bill Cassidy (R-La.), the chair of the Senate Health, Education, Labor and Pensions Committee who organized the briefing for select GOP senators, in a statement also blasted “the lack of progress on HHS and FDA’s promised safety study on these dangerous drugs” as “disappointing,” and complained the review was “moving too slowly.”
It’s not clear what comes next. Republicans have previously tried and failed to impose restrictions on mifepristone, which is used in more than two-thirds of abortions, through government funding legislation. Hawley said he has not yet decided whether to attempt to place guardrails on the drug as part of the next appropriations process or introduce a standalone bill, but that he will roll out his plans in the coming weeks.
“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.”
Reached for comment, HHS spokesperson Andrew Nixon referred POLITICO to a previous agency statement asserting 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,” the statement reads, adding that such reviews “often take approximately a year or more to conduct.”
Conservative anger with the Trump administration has boiled over in recent months over its decision to leave in place Biden-era rules that expanded access to abortion pills via mail and telemedicine, and for approving a new generic version of the drug. Administration officials took narrower steps in January to roll back access to mifepristone at retail pharmacies, but the anti-abortion movement and its allies in Congress are pressuring the FDA to abolish telemedicine prescription of the pills or ban them altogether.
At the same time, several GOP states are suing the agency, including Cassidy’s Louisiana and Hawley’s Missouri. The administration has tried to rebuff these lawsuits, asking judges to wait until FDA’s ongoing study is completed before issuing a ruling. Anti-abortion activists, tired of waiting, have threatened to withhold resources from the GOP in the upcoming midterm elections if they don’t see action on the drugs.
