The FDA approved mifepristone more than 20 years ago to be used in combination with a second drug, misoprostol, to terminate pregnancies at up to 10 weeks.
Over half of U.S. abortions are done by
medication abortion, according to the
Guttmacher Institute, a research group that supports abortion rights.
The pills have become increasingly significant in the fights over abortion access that have ensued since Roe v. Wade was overturned.
A coalition of anti-abortion groups, collectively called the Alliance for Hippocratic Medicine,
sued in November challenging the process through which the FDA evaluated and approved mifepristone. They argue that the government did not adequately assess the drug’s safety and should not have made it accessible via telehealth during the pandemic.
The plaintiffs sought an injunction to halt the use of mifepristone nationwide while the case plays out, which the judge granted, in part, on Friday.
"The Court does not second-guess FDA’s decision-making lightly," Kacsmaryk wrote. "But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions."
If the stay on the FDA's mifepristone approval goes into effect, the drug would no longer be available anywhere in the U.S. That would leave a surgical procedure or off-label use of misoprostol on its own as the only options in states where abortion is legal.
Misoprostol, which is not affected by the injunction, is not FDA-approved to terminate pregnancies on its own — doctors would have to prescribe it off-label for that purpose. Some abortion providers said they intend to do that if access to mifepristone is cut off, even though the one-drug approach has been shown in
clinical trials to be somewhat less effective than the two-pill regimen.