WASHINGTON — Before Scott Gottlieb was in charge of the Food and Drug Administration, he called on the agency to publicly release its rejection letters to drug manufacturers. But now as commissioner, he is stopping short of actually making that change.
“Releasing all the [complete response letters] would be administratively challenging, given the likelihood we would continue to redact certain proprietary information from these letters,” Gottlieb said Tuesday morning. He said that the agency is “evaluating whether there is a subset of complete response letters where there are especially important public health reasons to redact and release these letters.”
