The federal judges who heard arguments Wednesday in the fight over access to the most commonly used abortion pill in the U.S. questioned the Biden administration's position that the drug mifepristone should remain widely available.
The hearing at the 5th U.S. Circuit Court of Appeals in Louisiana included arguments from the Justice Department and drugmaker Danco Laboratories on one side and a group of doctors and medical professionals who oppose abortion on the other. The three-judge panel heard the case after the Supreme Court said the status quo on mifepristone's availability should remain in place while the appeals process plays out.
A Justice Department attorney representing the Food and Drug Administration, as well as a lawyer for drug manufacturer, argued Wednesday that the court should not roll back access to mifepristone. They said the Alliance for Hippocratic Medicine, the group challenging the drug's FDA approval, did not have legal standing to do so — a position the judges seemed skeptical of and asked them numerous questions about.
Two of the judges — Cory Wilson and James Ho — were nominated by former President Donald Trump, while the third, Jennifer Walker Elrod, was nominated by former President George W. Bush.
Justice Department lawyer Sarah Harrington told the panel one reason the group does not have standing is that the doctors who are concerned about having to treat patients who have suffered complications from the drug could opt out of doing so on religious or conscience grounds.
None of the doctors who submitted declarations testified they were compelled to perform abortions against their will, Harrington said. "Seeing and treating patients on its own is not an injury," she said.
The challengers argue the FDA’s approval of the drug in 2000 was “arbitrary and capricious” and should be revoked.
The judges questioned whether the FDA had done due diligence before it made changes in recent years that made the drug more accessible, with Ho asking Harrington whether the FDA would comply with whatever ruling the panel handed down. "Of course," she said.
Jessica Ellsworth, a lawyer representing Danco Laboratories, also took aim at the doctors' declarations, saying they were largely "non-specific statements untethered to actual facts" about the underlying cases, including some instances in which it is unclear whether the patients had taken mifepristone.
The lawyer for the challengers, Erin Hawley, insisted that her clients do have standing and had been forced to be "complicit" in abortion procedures, with a reasonable fear they would again. Asked if any of the doctors had tried handing the cases off to a different doctor, Hawley said, "I'm not sure," adding that being involved in the treatment at all would still impact them and subject them to "irreparable harm."
Overall, Hawley faced fewer questions and interruptions than the attorneys for the government and Danco.
The Alliance for Hippocratic Medicine contends that mifepristone is not as safe as the FDA has determined. "The crux of Plaintiffs’ arguments is that FDA’s judgment was not based on the required scientific evidence. The agency’s position—that no court is worthy of checking FDA’s work—reeks of hubris," the challengers said in a court filing.
The group also argues that changes the FDA made in recent years — allowing the drug to be sent to patients by mail and expanding the pool of eligible patients — should be reversed. Hawley told the judges Wednesday that the agency had "put politics over women's health" and that the use of the drug needed to be reined in.
The three-judge panel can issue its ruling at any time, with an appeal to the Supreme Court likely.
Hawley told reporters after the hearing that "the public interest weighs in favor of taking this dangerous drug with no meaningful safeguard off the market."
Ellsworth said in a statement that “We appreciate the Court’s careful time and attention to these important issues at the hearing today.”
The FDA declined comment.
The case started in Texas, where U.S. District Judge Matthew Kacsmaryk sided with the challengers last month, suspending the FDA’s 2000 approval of mifepristone. Kacsmaryk, a Trump appointee, cited in part what he called "evidence indicating FDA faced significant political pressure" to approve the drug more than two decades ago.
The Justice Department then filed an emergency appeal of Kacsmaryk's order to the 5th Circuit, arguing the ruling “upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety.”
The government also argued that pulling a drug's approval after more than two decades would cause tumult in the pharmaceutical industry. "Allowing plaintiffs to challenge mifepristone’s approval at this late date, after the drug has been on the market for over two decades, would be profoundly disruptive," the government argued.
In an emergency ruling last month, a separate three-judge panel agreed that at this stage of the litigation the drug's initial approval should not be revoked but agreed with Kacsmaryk that the challengers were likely to prevail on their other claims, including rolling back the mail provision and another that allowed the pills to be prescribed to women at up to 10 weeks’ gestation instead of the previous seven weeks.
The Supreme Court weighed in on April 21, saying the status quo should remain in place until the appeals process plays out in the 5th Circuit, meaning that for now access to mifepristone is the same as it was before Kacsmaryk's ruling.
In one exchange at Wednesday's hearing, Judge Elrod criticized Danco's attorney over what she characterized as unusually harsh language the company used in one of its court filings, which called a lower court judge’s ruling an “unprecedented judicial assault” on the FDA’s decision-making.
“Do you think its appropriate to attack the district court personally in that way?” Elrod asked.
Ellsworth said the comment was not meant as a personal attack.
All three judges at Wednesday's hearing have histories of supporting restrictions on abortion, The Associated Press reported this week. Ho called abortion a "moral tragedy" in a 2018 ruling.
The fight over mifepristone also involves a court case in Washington state, where a federal judge last month issued a preliminary injunction barring the FDA from “altering the status quo and rights as it relates to the availability of mifepristone.”
That ruling applies only to Washington, D.C., and the 17 liberal-leaning states that sued in February challenging the FDA’s regulations over the drug, arguing they were too cumbersome.
The judge in that case, Thomas O. Rice, an Obama appointee, issued a subsequent order specifying that the FDA cannot make any moves to comply with the 5th Circuit’s decision in the states affected by the case before him, increasing the odds for an eventual showdown at the Supreme Court over mifepristone.
The challenges to the drug come on the heels of the Supreme Court's 5-4 ruling last summer overturning the landmark Roe v. Wade decision, which had guaranteed a constitutional right to abortion for the previous 50 years.
In its filing, the Alliance for Hippocratic Medicine said the FDA's actions expanding the availability of mifepristone in recent years "subvert the promise" of last year's Supreme Court ruling.
In court filings, the FDA maintained the drug is safe. “Americans have been safely using mifepristone for over two decades. More than five million women in the United States have used mifepristone to terminate their pregnancies, as have millions of other women around the world. And study after study has shown that serious adverse events are exceedingly rare.”
Mifepristone is still available in the 37 states that legally allow some form of medication abortion. Experts have said that if the FDA’s approval of the drug is revoked, anyone involved in manufacturing or distributing it could face legal risk.
In an interview Wednesday with MSNBC's Katy Tur, New Jersey Gov. Phil Murphy, a Democrat, said he was considering placing a bulk order of mifepristone in case the courts rule against the FDA.
Asked if New Jersey would make the drug available in defiance of a Supreme Court order, Murphy said, “To be determined. When I say everything is on the table, Katy, I mean that.”