A federal appeals court preserved access to the abortion drug mifepristone Wednesday, following a district court ruling and several states’ efforts to stop the sale of the drug.
On April 8, U.S. District Judge Matthew Kacsmaryk found unlawful the U.S. Food and Drug Administration’s (FDA) decades-old approval of the drug, claiming it violated a rule that allowed for fast-tracking of certain drugs, according to CBS News.
Kacsmaryk delayed the enforcement of his decision for one week, however, so that the Biden administration could appeal to the Fifth Circuit for a stay of the judgment while its appeal of that judgment is pending.
On Monday, the Biden administration asked the Fifth Circuit to put the district court’s order on hold, calling Kacsmaryk’s ruling “extraordinary and unprecedented,” according to CBS News.
The April 12 ruling by the Fifth Circuit, granting in part the motion by the government, prevented Kacsmaryk’s order from being fully executed, thereby upholding the sale of the drug, finding that “the statute of limitations bars plaintiffs’ challenges to the [FDA’s] approval of mifepristone in 2000.”
The appellate court, however, also denied the government’s motion in part because it found that some of the plaintiffs’ arguments, which were based on the FDA’s “reopening” its decision about the drug in 2016 and again in 2021, were timely and the government failed to show that plaintiffs were unlikely to succeed on those challenges.
The result is that the changes made by the FDA in 2016 and 2021, which include things such as increasing the time frame during which the drug can be prescribed from 7 weeks to 10 weeks, requiring that the administration of the drug take place in-clinic, and allowing the drug to be dispensed through the mail, will go into effect while Kacsmaryk’s decision is being challenged on appeal.
Commenting on Kacsmaryk’s decision, President Biden alleged, “The lawsuit, and this ruling, is another unprecedented step in taking away basic freedoms from women and putting their health at risk,” according to CBS News.
White House press secretary Karine Jean-Pierre said the Biden administration will fight to restore full approval of the drug. “We believe that the law is on our side, and we will prevail,” she said, per CBS News.
The Justice Department is seeking emergency relief from the Supreme Court as to the portion of Kacsmaryk’s judgment that was left intact by the partial denial of the government’s motion for a stay, per CBS News.
“The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal,” said Attorney General Merrick Garland in a statement. “We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”
Meanwhile, Democrat-led states are preparing in case mifepristone gets banned by stocking up on misoprostol, another abortion drug that can be taken without mifepristone. However, it is slightly less effective, according to CBS News.
California Gov. Gavin Newsom said his state received an emergency supply of 2 million misoprostol pills, and New York Gov. Kathy Hochul said her state would stock 150,000 pills.
