A federal appeals court panel on Wednesday appeared skeptical of the Biden administration’s arguments to keep the widely used abortion pill mifepristone on the market in its current form.
In oral argument, a three-judge panel of the US 5th Circuit Court of Appeals – all nominated by Republican presidents – grilled attorneys from the Department of Justice and Danco, the maker of the mifepristone brand, who are trying to keep drug available.
Seconds after Deputy Attorney General Sarah Harrington’s argument, she was interrupted by Judge James Ho, who disputed her claim that the lower court’s ruling was an unprecedented intrusion on the Food and Drug’s authority Administration (FDA).
“Sorry to interrupt you so early, but you said ‘unprecedented’. We had a challenge with the FDA just yesterday,” said Ho, a former President Trump appointee.
Ho’s questioning set the tone for the nearly two hours that followed.
The panel appeared sympathetic to the arguments of the plaintiffs, a group of anti-abortion physicians and physician groups, that the FDA has overlooked a myriad of safety concerns as it has made policy changes to make drugs more widely available.
But two of the three justices seemed more hesitant about arguments that the court should have withheld the FDA’s original approval of mifepristone in 2000. A lower court had blocked all the agency’s actions.
The ruling won’t come for weeks or months, but it’s unlikely to have an immediate impact.
Judges last month preserved the status quo, suspending sentences in the case threatening access to mifepristone until the appeals process is resolved. It is widely expected that the losing party will take the case back to the Supreme Court.
The case marks the biggest abortion legal battle since the Supreme Court overturned Roe v. Wade last year. Any panel ruling limiting the availability of mifepristone would strike a major blow to the Biden administration in its effort to preserve access to abortion.
The jury first expressed doubts about the administration’s position that the doctors and physician groups did not show enough harm to have standing to sue in the first place.
“Dr. Scott has done it dozens of times already and says he will continue to do it. What else does it need according to the existing jurisprudence? Judge Jennifer Elrod, appointed by 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 conscientiously objecting doctors.
“The plaintiff doctors were forced to participate in and complete elective abortions, contrary to their conscience,” Erin Hawley, a senior counsel at the conservative legal group Alliance Defending Freedom, told the justices.
Elrod and Judge Cory Wilson, appointed by former President Trump, specifically questioned the administration and the drugmaker about recent changes made by the FDA since 2016 that have eased access to the pill.
These changes included increasing the gestational age at which mifepristone can be used up to 10 weeks of pregnancy, allowing the drug to be shipped to patients, allowing providers other than doctors to prescribe the drug, and approving a generic version of mifepristone .
“I am just struck by what the FDA has done to make it more available…. you’ve made it much more likely that patients will go to the emergency room or a medical clinic where one of these doctors is a member,” Wilson said.
But Harrington rejected.
“We are very much in dispute that many women will present in emergency rooms, or that others will present in emergency rooms needing emergency care for taking mifepristone,” she said.
More than 5 million women have taken mifepristone since it was first approved in 2000, and the FDA and major medical groups say it’s safe. According to the American College of Obstetricians and Gynecologists, serious side effects occur in less than 1 percent of patients taking mifepristone.
What’s more unclear is whether the panel will go so far as to block the FDA’s original approval of mifepristone in 2000. The Justice Department and the drug’s maker say challengers waited too long to sue such claims.
“Any challenge to the action of 2000 is clearly prescribed. They waited eight months over the statute of limitations,” Harrington said.
Challengers have argued that the deadline should be extended because recent FDA actions have effectively reopened the question of their original approval, but Elrod and Wilson have expressed concerns about where to draw the line.
“Any time the FDA eases some previous restriction, or requirement or safeguard based on performance history, does that mean we’re here for a reopening issue?” Wilson asked the plaintiffs.
Ho has, however, repeatedly indicated hostility to the original FDA approval of mifepristone.
It took the agency years to study and approve the drug, though it used a fast-track process typically reserved for drugs that treat serious or life-threatening illnesses. Ho echoed the challengers’ argument that pregnancy shouldn’t be considered a disease.
“When we celebrated Mother’s Day, were we celebrating sickness?” I said.
This story was updated at 17:02.
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