Lawyers seeking to preserve pregnant women’s access to a drug used in the most common method of abortion got pushback Wednesday from appellate judges with a history of supporting abortion restrictions.
A three-judge panel of the 5th U.S. Circuit Court of Appeals heard arguments over whether the Food and Drug Administration approval of mifepristone should be revoked more than two decades after it was granted. The case is likely to wind up at the Supreme Court, which already intervened to keep the drug available while the legal fight winds through the courts. The high court’s decision came after a Texas-based judge revoked the drug’s approval.
Biden administration attorney Sarah Harrington opened by calling U.S. District Judge Matthew Kacsmaryk’s April 7 ruling an “unprecedented and unjustified attack on the FDA’s scientific expertise.”
“I hate to cut you off so early, but you said, `unprecendented’,” Judge James Ho said, referring to an unrelated case that was argued Tuesday. “We had a challenge to the FDA just yesterday.”
“Yes, but I don’t think there’s ever been a court that has vacated the FDA’s determination that a drug is safe to be on the market. ... It’s not a court’s role to come in and second-guess that expertise,” Harrington told Ho, who was appointed to the court by former President Donald Trump.
There is no precedent for a U.S. court overturning the approval of a drug that the FDA has deemed safe and effective. While new drug safety issues often emerge after FDA approval, the agency is required to monitor medicines on the market, evaluate emerging issues and take action to protect U.S. patients. Congress delegated that responsibility to the FDA — not the courts— more than a century ago.
Arguments Wednesday went on for two hours, with Harrington and Jessica Ellsworth, an attorney for Danco Laboratories, telling the panel that the doctors and groups who brought the lawsuit did not have a right to sue because they failed to prove they have been or would be harmed by the approval of mifepristone. Their claims that they would be forced to treat people who suffer complications from mifepristone — perhaps even completing abortions when the drug fails — are “speculative,” Harrington said.
All three judges seemed skeptical of that argument.
“It just strikes me that what the FDA has done in making this more available ... is 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,” said Judge Cory Wilson, another Trump appointee.
