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 — which the judge granted, in part — to halt the use of mifepristone nationwide while the case plays out.
"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.
On Friday night, the Department of Justice filed a notice of appeal to the Fifth Circuit Court of Appeals, indicating that the government plans to appeal. Attorney General Merrick Garland also said in a statement that the DOJ plans to appeal Kacsmaryk’s decision.
“Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective. The Department will continue to defend the FDA’s decision,” Garland said.