The court said a preliminary review suggests that a statute of limitations barred a challenge to the FDA’s 2000 approval of the abortion drug.
The order from the conservative U.S. Court of Appeals for the 5th Circuit came after the Justice Department and the drug manufacturer on Monday asked the court to put on hold the decision by the judge in Texas. Mifepristone is used in more than half of all abortions in the United States.
On Friday evening, U.S. District Judge Matthew Kacsmaryk, a nominee of President Donald Trump with long-held antiabortion views, sided with conservative groups that had sued the Biden administration. He agreed that the Food and Drug Administration did not follow proper procedure two decades ago when it approved mifepristone — one of the two medications used to terminate pregnancies — and ignored safety concerns.
The Justice Department appealed the decision Monday in the 5th Circuit, saying that the challengers, a group of antiabortion doctors and medical associations, had no right to file the lawsuit because they were not personally harmed by the abortion pill and that their claims were baseless.
The FDA approved the drug after clinical trials involving thousands of pregnant patients showed a low rate of complications. More than 5 million women in the United States have used the medication.
Ultimately, the issue of access to mifepristone is likely to be decided by the Supreme Court and would present the nation’s highest court with its biggest test on abortion access since its landmark decision in June to knock down the nearly 50-year federal guarantee of abortion rights provided by Roe v. Wade.
In November, the Alliance for Hippocratic Medicine filed the lawsuit in Kacsmaryk’s Amarillo, Tex., courthouse seeking to reverse the FDA’s approval of mifepristone as safe and effective, including in states where abortion rights are protected. The attorneys for the groups argued that mifepristone is unsafe — a claim that has been rejected by medical experts — and that the FDA did not follow proper protocol when approving its use.
The government’s attorneys argued that the scientific evidence has repeatedly proved mifepristone to be safe and effective since the FDA approved its use in 2000. The agency has subsequently taken steps to loosen restrictions on how the pill is administered.
Both groups acknowledged in the hearing that there is no precedent for a court to order the suspension of a long-approved medication.
Separately, a group of Democratic state attorneys general filed a lawsuit in February in Washington state seeking to expand access to mifepristone.
Shortly after Kacsmaryk issued his ruling Friday, Judge Thomas O. Rice delivered his ruling in the Washington state case, ordering the FDA to preserve “the status quo” and retain access to the abortion medication in the jurisdictions that filed the lawsuit, including 17 states and the District of Columbia. Rice was appointed during the Obama administration.
On Monday, the Justice Department asked the judge in the Washington state case for clarification on how to reconcile the contradictory opinions.
