During oral arguments in a case challenging FDA approval of remote dispensing for abortion pills, Justice Ketanji Brown Jackson questioned whether courts have “specialized scientific knowledge” to second-guess the FDA, in response to Justice Samuel Alito implying the FDA could be wrong.
Alito had pressed the solicitor general on whether “the American people have no remedy” if the FDA approves a drug, suggesting courts should be able to review such decisions.
“Shouldn’t someone be able to challenge that in court?” Justice Samuel Alito asked Solicitor General Elizabeth Pregolar. “The American people have no remedy for that?”
“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?” Alito asked Danco attorney Jessica Ellsworth.
Jackson later asked Ellsworth if judges have expertise to “parse medical and scientific studies,” or if allowing such challenges could undermine the FDA approval process relied on by drug makers.
Her comment echoed amicus briefs citing industry concerns that the case could set a precedent allowing more legal disputes over FDA decisions.
“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?” Jackson asked.
“Do you have concerns about judges parsing medical and scientific studies?”
Ellsworth noted that 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,” Ellsworth said.
While Alito seemed skeptical of the FDA, most justices appeared unlikely to grant the anti-abortion group challenging the ruling legal standing by the arguments’ end.
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