The nomination of Dr Lester Crawford as the new US Food and Drug Administration commissioner faced another setback yesterday after US senators, Patty Murray, and Hillary Rodham Clinton, said they would continue to place a hold on the nomination until the agency issues a definitive decision on whether to approve Barr Laboratories’ Plan B (levonorgestrel) over-the-counter emergency contraceptive.
The FDA controversially turned down Barr’s application for Plan B even though its advisory panel had backed the product’s approval [[17/12/03a]]. The company has since refiled its application, excluding the use of Plan B in girls under the age 16, and an FDA decision had been expected by a January 2005 deadline [[23/07/04b]], [[25/01/05d]].
At a Senate Health Education and Labour Committee hearing in March, the senators pressed Dr Crawford to answer questions about the long-pending application for OTC Plan B [[21/03/05c]], but note that a decision has still not been made.
“Our request is simple and straightforward. We want the FDA to make a decision – yes or no. After almost two years of waiting, the American people have the right to an answer,” said senator Clinton. “At a time when the FDA needs a strong leader to restore its reputation, I fear that Dr Crawford’s record demonstrates a lack of vision and drive to ensure that the FDA upholds its gold standard of drug regulation. He has failed to address the concerns raised by his own employees about the needs of the agency. And he cannot provide assurances that the FDA will make science, not ideology or other interests, the cornerstone of its decision making.”
“All we are asking for today is that FDA follows procedures set out in law for drug approval,” senator Murray added. “We are placing a hold on Dr Crawford because it is time to return credibility to FDA.”