The Biden administration on Wednesday asked the 5th U.S. Circuit Court of Appeals to reverse a ruling that would revoke federal approval of mifepristone, part of a two-drug regimen used in medication abortions.
Calling U.S. District Judge Matthew Kacsmaryk’s ruling an “unprecedented order countermanding the scientific judgment” of the Food and Drug Administration (FDA), the Justice Department urged a three-judge appeals panel to completely overturn his decision.
Oral arguments are scheduled for May 17, and Kacsmaryk’s ruling remains on hold during the appeal after an emergency intervention from the Supreme Court.
In its brief, the Justice Department asserted that mifepristone is and has been a safe and effective drug since it was first approved 23 years ago.
The administration asserted the attempt by Kacsmaryk to undo that approval was “based on the court’s deeply misguided assessment of mifepristone’s safety.”
“FDA’s actions were amply supported by a record developed over decades of safe and effective use of mifepristone in the United States and around the world,” the Justice Department wrote.
“While FDA justified its scientific conclusions in multiple detailed reviews, including a medical review spanning more than 100 pages and assessing dozens of studies … the district court swept the agency’s judgments aside by substituting its own lay understanding of purportedly contrary studies,” the DOJ said.
Further, the administration argued that if the decision were upheld, its harms would be felt nationwide.
It would “thwart FDA’s scientific judgment and profoundly harm women who rely on mifepristone as an alternative to more burdensome and invasive surgical abortions,” DOJ wrote.
Kacsmaryk’s order, DOJ wrote, is also damaging to healthcare providers and drug sponsors who “rely on FDA’s scientific judgment and orderly administration of the nation’s complex system of drug regulation.”
The administration further asserted that the plaintiffs, who are a group of anti-abortion physicians and organizations representing physicians, don’t actually have any legal standing to sue, because they are not harmed enough by mifepristone’s approval.
Kacsmaryk ruled that they had standing based on multiple theories, and the Justice Department pushed back that those arguments are too speculative or have been previously rejected in other cases.
“They neither take nor prescribe mifepristone, and FDA’s approval of the drug does not require them to do or refrain from doing anything. Yet the district court held that the associations have standing because some of their members might be asked to treat women who are prescribed mifepristone by other providers and who then suffer an exceedingly rare serious adverse event,” the DOJ wrote, responding to one of the standing arguments.
The appeals panel previously noted that one of the plaintiff’s three theories had been disavowed by the Supreme Court in other abortion cases. As for the other theories, however, the Biden administration may face an uphill battle.
“At this preliminary, emergency stage, we are unpersuaded by applicants’ contentions that all of these theories fail to create a justiciable case or controversy,” the panel wrote in a ruling earlier this month.
