U.S. Supreme Court Justice Ketanji Brown Jackson delivered a sizzling retort to fellow Justice Samuel Alito Tuesday, questioning his “specialized scientific knowledge” of abortion-inducing drugs.
The justices heard arguments Tuesday morning from a lawyer for the anti-abortion Alliance for Hippocratic Medicine, which holds that the FDA erred in allowing mifepristone, one of the drugs used in a medication abortion, to be dispensed remotely. The FDA and most major medical associations say the ruling is sound, pointing to studies showing no difference in severe complications when the pills are dispensed via telemedicine versus in person.
Lawyers for the FDA and for the lead producer of mifepristone, Danco Laboratories, argued Tuesday that the alliance did not have standing to argue the case, as none of its members take or prescribe the drug.
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Alito pushed back, asking Solicitor General Elizabeth Pregolar, the lead attorney for the government, who if anyone should be allowed to challenge the FDA’s ruling in court.
“Shouldn’t someone be able to challenge that in court?” he asked, adding, after she said she could not think of anyone who should: “The American people have no remedy for that?”
He later questioned Danco attorney Jessica Ellsworth along the same lines, asking if the FDA had ever approved a drug and then rescinded it after receiving reports of complications.
“During the questioning of the solicitor general, the statement was made that no court has ever previously second-guessed the FDA's judgment about access to a drug,” Alito said.
“Do you think the FDA is infallible?”
Jackson made clear her thoughts about Alito’s question in her own questioning of Ellsworth.
“You were asked if the agency is infallible, and I guess I’m wondering about the flip side, which is do you think that courts have specialized scientific knowledge with respect to pharmaceuticals?” she asked.
As a representative for a company that produces pharmaceuticals, she added, “Do you have concerns about judges parsing medical and scientific studies?”
Ellsworth said she did.
“There are two amicus briefs from the pharmaceutical industry that expand on why exactly that's so concerning for pharmaceutical companies who do depend on FDA's gold standard review process to approve their drugs,” she said.
Hundreds of drug company executives signed onto the briefs Ellsworth mentioned, which argued that allowing the Alliance to challenge the FDA’s regulation on mifepristone would upend the existing approval and regulatory system. Ovid Therapeutics CEO Jeremy Levin, one of the executives who signed on, previously called the case a “dagger at the heart of the entire industry.”
The manufacturers may have little to fear. Despite Alito’s testy line of questioning, most of the justices appeared likely to deny the alliance standing by the time oral arguments concluded.
