Appeals Court Rules Abortion Pill Mifepristone Can Remain Temporarily Available

Federal judge in Texas had last week suspended FDA’s approval of the abortion pill

A federal appeals court approved an emergency request by the Biden administration to allow a widely used abortion pill to remain on the market while a lawsuit challenging the drug’s approval continues.

A federal judge in Texas issued a ruling late last week suspending the U.S. Food and Drug Administration’s approval of the abortion pill, known as mifepristone, a decision that was set to take effect Friday.

The New Orleans-based Fifth U.S. Circuit Court of Appeals put the Texas decision on hold in a ruling late Wednesday, following a motion filed by the Justice Department. While the decision means mifepristone can remain on the market while the legal case continues, the court upheld some restrictions on its availability.

The drug can only be used during the first seven weeks of pregnancy and requires three in-person doctor visits.

The Justice Department had asked the appeals court to rule by Thursday afternoon, so the administration would have enough time to seek intervention from the Supreme Court, if necessary.

White House press secretary Karine Jean-Pierre said Thursday, “We are going to continue to fight in the courts. We believe the law is on our side and we will prevail.”

Mifepristone is used in more than half of abortions around the country. U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, ruled on April 7 that the FDA had improperly approved the drug in 2000 under a pathway used for medications to treat life-threatening illnesses and had failed to adequately assess its safety. He put his ruling on hold for a week to give the parties an opportunity to appeal.

The Biden administration argued in its request to stay the ruling that it could cause nationwide harm. “If allowed to take effect, the court’s order would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity,” it said in court papers.

The case has captured nationwide attention over its potential to upend the abortion landscape even in places such as New York and California, where the procedure remains legal.

Dozens of parties filed amicus briefs this week, including more than 300 members of Congress, 55 former high-ranking Justice Department officials, and Democratic and Republican state attorneys general. A coalition of pharmaceutical and biotech companies—including Pfizer Inc. and Gilead Sciences Inc.—filed a brief that said allowing the Texas judge’s ruling to stand would harm drug development and patients broadly.

The possibility that the pill could be pulled from the market set off a scramble among Democratic governors to try to protect access. States including New York, California, Massachusetts and Washington have announced plans to stockpile abortion drugs. But other Democrats unhappy with the judge’s decision have said they believe such moves could prove counterproductive.

“I sometimes worry that if people keep talking about stockpiling, there will be a rush for all these drugs and it will drive up prices for everybody,” said Connecticut Gov. Ned Lamont, who said he wants to maintain access in his state.