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The U.S. Food and Drug Administration (FDA) has launched a study that purports to examine the safety of the widely used abortion medication mifepristone, a move that critics say could be used as a means to further regulate the drug and restrict abortion access.
FDA administrators deny that the study, revealed in a Wall Street Journal report late last week, is new, asserting it has been going on for several months.
“Any reporting suggesting otherwise, including that a study is just being started, is either false or based on a fundamental misunderstanding of how complex scientific safety studies work,” a spokesperson for the agency said.
The timing of the study being disclosed may cause some to think otherwise, as it comes just weeks after the Supreme Court took action to halt restrictions on mifepristone.
Last year, the state of Louisiana sued to stop the FDA’s current practice of allowing mifepristone to be delivered through the U.S. Postal Service. On May 4, the Fifth Circuit Court of Appeals sided with the state and placed restrictions on the drug, only allowing it to be prescribed and delivered in person — a nearly impossible option for Louisiana residents, given the state’s extreme restrictions on abortion in general.
However, the following week, the Supreme Court placed a stay on that order, allowing, for now, the sending of mifepristone by mail to continue as the issue is further litigated in lower courts.
Less than one month after that action, the existence of an FDA study on the drug came to light.
Abortion medication accounts for approximately two-thirds of all abortions performed in the U.S. The FDA’s study is expected to last for about six months, but “preliminary results” could come as soon as July. Critics maintain that the study’s true scope and purpose are to eventually place more burdensome restrictions on abortion medication.
“The FDA’s review is a politically motivated farce,” read a statement from Planned Parenthood Action Fund President and CEO Alexis McGill Johnson. “Mifepristone is safe and effective. We know it, the FDA knows it, and the more than 7.5 million people who’ve used mifepristone for abortion and miscarriage care over the past 25 years know it too.”
“The Trump administration is bulldozing the overwhelming body of medical research and evidence to try to make it harder for everyone, everywhere to get an abortion,” McGill Johnson added. “It’s time for every American to take this threat seriously.”
In a social media post, reproductive rights reporter Garnet Henderson suggested that the Trump administration was opening the inquiry into mifepristone to placate far right, anti-abortion voters in the lead-up to this fall’s elections.
“Anti-abortion groups have long complained about the Trump admin’s inaction on this. Serious threats to withhold electoral support must have been made for this to happen before the midterms,” Henderson said.
“[The] FDA opening a new study has nothing to do with science and everything to do with advancing the anti-abortion movement’s agenda to control women’s bodies and lives,” Sen. Patty Murray (D-Washington) said.
“The Trump administration is using this sham review to tee up baseless, nationwide restrictions on medication abortion,” read a post on Bluesky by the American Civil Liberties Union. “Mifepristone is safe and effective — just ask the millions of patients who have used it.”
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