February 17, 2006
FDA official denies politics delaying Plan B decision
The FDA’s acting director refuted concerns that politics are delaying the agency’s review of an OTC switch petition for Plan B, the AP reports.
Andrew von Eschenbach told House members that the decision on the morning-after contraceptive pill, marketed by Barr Labs, would be based on science.
"That process will be carried out in the appropriate fashion," he said, while appearing before a House Appropriations subcommittee to go over the agency's budget.
House Democrats pressed von Eschenbach on the issue, saying the agency has had ample time to reach a decision.
Under Barr’s revised application—the FDA rejected its initial OTC petition in 2004—Plan B would become available over the counter to patients 16 and above but remain a prescription drug for younger ones.
Those age limits create a novel situation for the FDA, which has not considered the same product as both a prescription and OTC drug. Von Eschenbach declined to say when the agency might rule, adding that it was reviewing public comment.