A federal appeals court panel Wednesday seemed skeptical of the Biden administration’s arguments to keep the widely used abortion pill mifepristone on the market in its current form.
During oral arguments, a three-judge panel on the 5th U.S. Circuit Court of Appeals — all appointed by Republican presidents — grilled attorneys from the Department of Justice and Danco, the manufacturer of the brand name mifepristone, who are attempting to keep the drug available.
Just seconds into Deputy Assistant Attorney General Sarah Harrington’s argument, she was interrupted by Judge James Ho, who challenged her assertion that a lower court’s ruling was an “unprecedented” intrusion upon the Food and Drug Administration’s (FDA) authority.
“I hate to cut you off so early, but you’ve said ‘unprecedented.’ We had a challenge to the FDA just yesterday,” said Ho, an appointee of former President Trump.
Ho’s questioning set the tone for the nearly two hours that followed.
The panel appeared sympathetic to arguments by the plaintiffs, a group of anti-abortion physicians and physician groups, that the FDA failed to consider a myriad of safety issues when it adopted policy changes that make the drugs more widely available.
But two of the three judges seemed more hesitant toward arguments that the court should suspend the FDA’s original approval of mifepristone in 2000. A lower court had blocked all of the agency’s actions.
The ruling won’t come for weeks or months but is unlikely to have an immediate impact on the drug’s availability.
The justices last month preserved the status quo, pausing rulings in the case that threaten access to mifepristone until the appeals process is resolved. The losing party is widely expected to bring the case back to the Supreme Court.
The case marks the highest-stakes legal battle on abortion since the Supreme Court overturned Roe v. Wade last year. Any ruling by the panel that restricts the availability of mifepristone would mark a major blow to the Biden administration in its attempt to preserve access to abortion.
The panel first expressed doubt in the administration’s position that the doctors and physician groups didn’t show enough harm to have legal standing to sue in the first place.
“Dr. Scott has already done this dozens of times, and she says that I’m going to continue to be doing this. What more does she need under the existing case law?” Judge Jennifer Walker Elrod, an appointee of former President George W. Bush, asked Harrington.
The challengers also argued that women who take mifepristone will suffer emergency injuries from the drug, and will need to be treated by doctors with conscience objections.
“Plaintiff doctors have been forced to participate in and complete elective abortions, contrary to their consciences,” Erin Hawley, senior counsel at conservative legal group Alliance Defending Freedom, told the judges.
Elrod and Trump-appointed Judge Cory Wilson questioned the administration and drug manufacturer about changes the FDA made since 2016 that eased access to the pill.
Those changes included increasing the gestational age when mifepristone can be used to 10 weeks of pregnancy, allowing the medication to be mailed to patients, permitting providers other than physicians to prescribe the drug and approving a generic version of mifepristone.
“It just strikes me that what the FDA has done in making this more available …. you’ve made it much more likely that patients are going to go to emergency care or a medical clinic where one of these doctors is a member,” Wilson said.
But Harrington pushed back.
“We’re absolutely disputing that many women will show up in emergency rooms, or that more will show up in emergency rooms needing emergency care from taking mifepristone,” she said.
More than 5 million women have taken mifepristone since it was first approved in 2000, and the FDA and leading medical groups all assert it is safe. According to the American College of Obstetricians and Gynecologists, serious side effects occur in less than 1 percent of patients who take mifepristone.
It’s unclear whether the panel will go as far as to block the FDA’s initial approval of mifepristone. The Justice Department and the drug’s manufacturer contend the challengers waited too long to sue over those claims.
“Any challenge to the 2000 action is clearly time-barred. They waited eight months past the statute of limitations,” said Harrington.
The challengers contend the deadline should be extended because the FDA’s recent actions effectively reopened the issue of their original approval, but Elrod and Wilson raised concerns about where to draw the line.
“Is every time the FDA going to relax some prior restriction, or requirement, or safeguard based on history of performance, does that then mean we’re here on a reopening issue?” Wilson asked the plaintiffs.
Ho, however, repeatedly indicated hostility to the FDA’s original approval of mifepristone.
The agency took years to study and approve the drug, though it used an expedited process typically reserved for medications that treat serious or life-threatening illnesses. Ho echoed the challengers’ contention that pregnancy should not be considered an illness.
“When we celebrated Mothers’ Day, were we celebrating illness?” Ho said.
Updated at 5:02 p.m.