He said it will be up to U.S. District Judge Phyllis Hamilton to issue a final remedy decision. Kimbrell said he is hopeful the Judge Hamilton will issue a final remedy without any delay, but said timing of her next move is unknown.
Sebastian Cianci, spokesman for the FDA, said in a June 19 statement that the FDA’s new timeline for food safety regulations are reasonable, given the complexity of the provisions mandated under the Food Safety Modernization Act.
David Acheson, former FDA official and partner at Leavitt Partners, said he doubts that FDA will be forced by the court to comply with arbitrary deadlines.
“I think the FDA is saying that 'This is the best we can do guys,’ ” he said. “The court can scream and holler all it wants but that is reality.” Acheson said the consequences that the court could bring seem to be negligible. “Nobody is going to support a piece of garbage coming out just for some silly time line,” he said.
The good news, he said, for industry observers is that the FDA’s communication with the courts gives a better sense of how fast FDA is moving. “I will say that I think if they slip past those deadlines there is going to be a lot of hollering from a lot of people.”