US regulators have until September 1 to make a decision on whether to approve an over-the-counter version of Barr Laboratories’ emergency contraceptive, Plan B (levonorgestrel) – some seven months after a ruling had initially been expected [[25/01/05d]].
US senators Patty Murray and Hillary Rodham Clinton, who earlier this year placed a hold on their nomination of Dr Lester Crawford as the new US Food and Drug Administration commissioner until the agency issues a definitive decision on whether to approve Plan B [[16/06/05d]], have claimed the announcement as a victory, and have now agreed to release their hold on the nomination. “While we continue to have concerns about the lack of leadership and independent decision-making that Dr Crawford and the FDA have shown in this case, we have been clear all along that our hold on this nomination is about one thing only: the FDA’s failure to provide an answer on Plan B,” the senators said in a statement. “We will continue to closely monitor the actions of the FDA to ensure that American patients receive access to safe and effective treatments in a timely manner.”
The FDA controversially turned down Barr’s application for Plan B even though its advisory panel had backed the product’s approval back in 2003 [[17/12/03a]]. The company then re-filed its application, excluding the use of Plan B in girls under the age 16. An FDA decision had been expected by a January 2005 deadline, but none materialised – the ruling came in for much criticism and sparked allegations that the Bush Administration, which has implemented a more restrictive policy on issues such as abortion since coming to power, had exerted pressure on the FDA to delay or even quash the application [[23/07/04b]].