Crawford Says Plan B Decision Coming Soon

The FDA is nearing approval of a proposal that will grant OTC status to Barr Pharmaceuticals' emergency contraceptive Plan B, according to the agency's acting Commissioner Lester Crawford.

"The science part is generally done," Crawford recently told the Senate Committee on Health, Education, Labor, and Pensions (HELP). "We're just down to what the label will look [like]. This is going to be a very unusual sort of approval. It is delayed, and I apologize for that."

Crawford's comments came in response to pointed questions from several Senate Democrats, who criticized the agency for dragging its feet on Plan B (levonorgestrel). Leading the debate on the issue was Sen. Hillary Rodham Clinton (D-N.Y.), who accused the FDA of putting political agendas ahead of science in its review of Barr's controversial drug.

"The experts have made their recommendations that the contraceptive should be made available. And it should be made available over the counter," Clinton said. "What has disturbed many of us is what appears to be political interference in a scientific process. I'm hopeful that we will reverse what appears to be a dangerous slide into political opinion rather than scientific evidence."

When pushed by committee members for a specific timeline for its Plan B decision, Crawford said the decision would likely come in a matter of weeks. Crawford insisted that when the agency does finally act on Plan B, the decision won't be based on politics, but he declined to provide further details. He did agree, however, to meet with senators to discuss the approval process before the committee takes its vote on his nomination.