FDA commissioner: 'No plans' to restrict mifepristone

WASHINGTON (OSV News) -- Food and Drug Administration Commissioner Martin Makary said April 24 he has "no plans" to restrict the availability of mifepristone, a pill commonly used for abortion.

In comments at the Semafor World Economy Summit, April 24, Makary said there was no plan to restrict mifepristone, which is the first of two drugs used in a medication or chemical abortion.

But Makary did not entirely rule out such restrictions, saying, "there is an ongoing set of data that is coming into the FDA on mifepristone."

"So if the data suggests something or tells us that there's a real signal, we can't promise we're not going to act on that data," he continued.

Semafor noted Makary "took a firmer stance on the issue" at their summit than he did in his Senate confirmation hearing in March, when he said he would "do a review of the data," neither committing to implementing restrictions on mifepristone nor outright rejecting them.

Pro-life activists have sought to reverse COVID-era rollbacks to restrictions on the drug or eliminate its approval altogether. Sen. Josh Hawley, R-Mo., called Makary's comments "exceptionally disappointing" in a post on X.

"Not a good beginning at the FDA," he wrote.

The U.S. Supreme Court unanimously dismissed a challenge to the drug's FDA approval last year, finding that the challengers lacked standing to bring the case.

A coalition of pro-life doctors and activists--represented by Erin Hawley, senior counsel at Alliance Defending Freedom and vice president of its Center for Life and Regulatory Practice and the senator's wife -- filed suit after the FDA loosened restrictions on the drug, including making it available by mail, arguing the government violated its own safety standards in doing so.

In its response to the case, the FDA argued the drug poses statistically little risk to the mother in the early weeks of pregnancy.

The Catholic Church teaches that all human life is sacred from conception to natural death, and as such, opposes direct abortion.