A federal appeals court appears skeptical of Biden administration arguments given on May 17 that a lower court ruling overturning a decades-old U.S. Food and Drug Administration (FDA) approval of abortion pill mifepristone was wrongly decided.
The case is one of many that have followed in the wake of the Supreme Court’s decision in June 2022 in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade and found there was no right to abortion in the U.S. Constitution. The ruling returned the regulation of abortion to the states.
The 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,” Kacsmaryk wrote at the time.
“There is also evidence indicating [the] FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion,” the judge wrote. The FDA’s failure to impose restrictions on the use of the drug “resulted in many deaths and many more severe or life-threatening adverse reactions,” he added.
The U.S. Department of Justice (DOJ) appealed the decision on April 12 and the New Orleans-based U.S. Court of Appeals for the 5th Circuit refused to block most of the order.
Challenge Facing Appeals Court
At the hearing May 17 before a three-judge panel of the 5th Circuit, DOJ attorney Sarah Harrington opened her presentation by saying that Kacsmaryk’s order was “an unprecedented and unjustified attack on [the] FDA’s scientific expertise.”“This court should vacate the order because plaintiffs are unlikely to prevail on any of their claims and because the balance of equities tips decidedly against preliminary relief,” the lawyer said.
Judge James Ho, a Trump appointee, was quick to interrupt Harrington, saying, “We had a challenge to the FDA just yesterday.”
Harrington acknowledged the challenge but said, “I don’t think there’s ever been any court that has vacated FDA’s determination that a drug is safe to be on the market.”
Ho said the FDA withdrew approval for a drug “just last month.”
Harrington replied: “FDA can make that determination based on exercising its own scientific expertise, but it’s not a court’s role to come in and second-guess that expertise and no court has ever done [that].”
Ho questioned whether an FDA decision has to be treated as sacrosanct.
“I don’t understand the statement that the FDA can do no wrong,” he said. “We are allowed to look at the FDA just like we’re allowed to look at any agency. That’s the role of the courts.”
Ho also reiterated concerns previously expressed by Justice Alito in his April 21 dissent that the Biden administration might not abide by the court’s order in this matter.
Alito wrote at the time that the FDA “has previously invoked enforcement discretion to permit the distribution of mifepristone in a way that the regulations then in force prohibited, and here, the government has not dispelled legitimate doubts that it would even obey an unfavorable order in these cases, much less that it would choose to take enforcement actions to which it has strong objections.”
Ho asked Harrington: “Will FDA follow whatever this court decides?”
“Absolutely,” Harrington said.
Harrington also argued that the lawsuit is barred by the statute of limitations and that the doctors who brought this lawsuit have no legal standing because they have not shown that prescribing mifepristone harms them. The doctors’ affidavits don’t actually say that they have been required to provide care that runs afoul of their consciences, she said.
Judge Cory Wilson, a Trump appointee, suggested the lawyer was trying to “split words” to get the lawsuit dismissed.
Attorney Erin Hawley of the Alliance for Defending Freedom, who represents the doctors, said the doctors have in fact “been forced to participate in and complete elective abortions, contrary to their consciences.”
Attorney Jessica Ellsworth, who acts for Danco Laboratories, which sells mifepristone, also questioned whether the doctors have standing.
“The question is not about whether someone will be injured by mifepristone somewhere some time,” she said. “It’s about whether any of the doctor declarants face certainly impending injury.”
Judge Jennifer Elrod, an appointee of former President George W. Bush, said Danco had personally attacked Judge Kacsmaryk.
Danco called the district court judge’s ruling an “unprecedented judicial assault” that was the product of a “relentless one-sided narrative,” Elrod said.
These are the kind of comments “we normally don’t see from learned counsel,” Elrod said.
Ellsworth said the criticism was based on Kacsmaryk’s analysis in the case.
“I don’t think those remarks … were intended as any kind of personal attack,” she said.
It is unclear when the 5th Circuit will issue its ruling.
