The justices heard arguments Tuesday morning from a lawyer for the anti-abortion Hippocratic Medical Association arguing that the FDA erred by allowing the remote administration of mifepristone, one of the drugs used in medication abortion. The FDA and most major medical associations say the decision was appropriate, pointing to studies showing no difference in serious complications between administering the pills via telemedicine and in person.
Lawyers for the FDA and Danco Laboratories, the lead manufacturer of mifepristone, argued Tuesday that the association had no right to argue the case because none of its members have taken or prescribed the drug.
Alito asked Solicitor General Elizabeth Pregolar, the government's lead lawyer, if there was anyone who could challenge the FDA's decision in court.
"Shouldn't someone challenge this in court?" he asked, and when Pregolar said she could think of someone who could, he added: "Don't the American people have a remedy for this?"
He then asked Jessica Ellsworth, Danco's lawyer, along the same lines, asking whether the FDA had ever approved a drug and then revoked it after receiving reports of complications.
"During the Solicitor General's questioning, it was noted that no court has ever second-guessed the FDA's decision on access to a drug," Alito said.
"Do you think the FDA is infallible?"
Jackson made his thoughts on Alito's question clear in his own question to Ellsworth.
"You were asked if you think the agency is infallible, and I guess I'm curious about the other side, which is do you think the courts have specialized scientific knowledge about drugs?" he asked.
As a representative of a pharmaceutical company, he added, "Do you have concerns about judges separating medical and scientific studies?"
Ellsworth said he had concerns.
"The pharmaceutical industry has two amicus briefs explaining why this is such a concern for drug companies that depend on the FDA's gold standard review process to approve their drugs," he said.
The hundreds of pharmaceutical company executives who signed the briefs cited by Ellsworth argue that allowing the Alliance to challenge the FDA's regulation of mifepristone would upend the current approval and regulatory system. One of the signatory executives, Jeremy Levin, CEO of Ovid Therapeutics, has previously called the lawsuit "a dagger in the heart of the entire industry."
Manufacturers may have little to fear. Despite Alito's tough questions, it seemed likely that most of the justices would reject the alliance when oral arguments ended.
