The case is likely to be taken to the Supreme Court, which has already intervened to keep the drug available while the legal battle winds its way through the courts.
NEW ORLEANS — Lawyers are trying to preserve pregnant women’s access to drugs used in the most common way on Wednesday, appellate judges who had previously upheld abortion restrictions were struck back.
A panel of three judges The 5th U.S. Circuit Court of Appeals heard arguments on whether to revoke the Food and Drug Administration’s approval of mifepristone more than two decades after it was granted. The case is likely to go to the Supreme Court, which has already intervened to keep the drug available while the legal battle winds its way through the courts. The High Court decision came after a Texas judge canceled the approval of the drug.
Sarah Harrington, a lawyer for the Biden administration, began by calling US District Judge Matthew Kaczmarik’s April 7 ruling an “unprecedented and unwarranted attack on the FDA’s scientific expertise.”
“I hate to stop you so early, but you said, ‘unprecedented,'” Judge James Ho said, referring to an unrelated case that was heard on Tuesday. “Yesterday we had a subpoena at the FDA.”
“Yes, but I don’t think there’s ever been a court that overturned the FDA’s determination that a drug was safe to sell. … The role of the court is not to come in and review that expertise,” said Harrington Ho, who was appointed to the court by former President Donald Trump.
There is no precedent for a US court to withdraw approval of a drug that the FDA has found to be safe and effective. While new drug safety concerns often arise after FDA approval, the agency has a duty to monitor drugs on the market, assess emerging problems, and take action to protect US patients. Congress delegated this responsibility to the FDA, not the courts, more than a century ago.
Arguments on Wednesday lasted two hours, as Harrington and Jessica Ellsworth, a lawyer for Danco Laboratories, told the panel that the doctors and groups that filed the lawsuit did not have standing to sue because they could not prove they were or would be harmed by the approval of mifepristone. . Their claims that they would be forced to treat people suffering from mifepristone complications — perhaps even completing abortions if the drug doesn’t work — are “speculative,” Harrington said.
All three judges seemed skeptical of this argument.
“I’m just amazed at what the FDA has done to make this more accessible … you’ve greatly increased the likelihood that patients will go to an emergency room or a medical clinic where one of these doctors is a member,” said Judge Corey Wilson, another Trump appointee.
Harrington disputed this, saying that mifepristone is extremely safe, rarely causes complications, and that doctors can use their conscience to opt out of the procedures.
But Erin Hawley, an attorney representing the anti-mifepristone plaintiffs, insists that anti-abortion doctors may be forced to follow their conscience when called upon to remove fetuses from the wombs of women who have had incomplete medical abortions.
“They claim that they feel complicit in the planned abortion, being forced to complete this procedure,” she said, answering questions from Judge Jennifer Walker Elrod, appointed by President George W. Bush.
The case goes to the Court of Appeal almost a year later The Supreme Court overturned Roe v. Wade the decree that enshrined the right to abortion. Fourteen states have since banned abortion at all stages of pregnancy, and other states have adopted or are debating major limitations.
Ho referred twice to the “FDA can do no wrong” theme in the pramifepristone argument.
“We’re allowed to look at the FDA the same way we’re allowed to look at any agency. That’s the role of the courts,” Ho told Ellsworth, who went on to say that the FDA had approved drugs that later discovered safety problems.
The third judge to hear the case was Jennifer Walker Elrod, a nominee of George W. Bush.
In November, abortion opponents filed a lawsuit in federal court in Amarillo, Texas Kachmarik, Trump’s nominee, presides. An appellate panel voted 2-1 to narrow, but not completely, Kaczmarik’s decision.
The commission’s April 13 decision said abortion opponents do not appear to be allowed a time limit to challenge the original authorization in 2000. But the group said adjustments made in later years — including allowing the drug to be mailed and administered without a doctor’s presence — could still be reversed.
Wednesday’s hearing also addressed the issue of the time limit and whether FDA changes made later in the year reset the clock and made full approval up for review.
“Does that mean that every time the FDA removes some prior restriction, requirement or protection based on a history of effectiveness, does that mean we’re here for a reopening? I mean, how do you draw that line?’ Wilson asked Hawley.
“Not at all, Your Grace,” she replied.
Other mifepristone regulations that have changed since the drug was originally approved include extending the time it can be used from seven to 10 weeks of pregnancy and reducing the dosage needed to safely terminate a pregnancy.
Mifepristone is one of two pills used in medical abortions, along with misoprostol. Health care providers said they may switch to misoprostol if mifepristone is no longer available or is too difficult to obtain. Misoprostol is somewhat less effective in terminating pregnancy.