Case marks 'only time' a court has limited FDA-approved drug: Prelogar
Justice Elena Kagan pressed Solicitor General Elizabeth Prelogar on the "arresting" statement from the government that this case marks the first time any court has restricted access to an FDA-approved drug.
"That is still to our knowledge the only time a court has done that," Prelogar responded.
"We have seen a disturbing trend of courts sometimes also overriding FDA's judgment to try to grant greater access to drugs and that overrides FDA expert judgment about what's necessary to ensure safe use," she continued. "And no matter which direction you come at it from we, on behalf of FDA, think that courts have no business making those judgments."