The Food and Drug Administration had intended to allow over-the-counter sales of Plan B last year but has delayed the move while determining how to limit sales of the emergency contraceptive pills to women 17 and older — a process that should have wrapped up by now, the agency's former chief testified.
Former FDA commissioner Lester Crawford, in a sworn statement, said he had reserved the right to decide whether to loosen the sales restrictions on the prescription-only pills. His account of that unusual and perhaps unprecedented move, given in a deposition over a lawsuit against the FDA, confirmed earlier testimony given by two senior agency officials who said he'd shut them out of the decision-making process.
But Crawford said his Aug. 26, 2005, announcement that the agency was delaying its decision on Plan B wasn't a move toward denying over-the-counter sales. Instead, it was a bid for time to work out how to enforce restricting nonprescription sales to women 17 and older. Girls 16 and younger would still need a prescription.
"There was no talk of denial, there was talk of trying to get straight what the enforcement procedures would be," Crawford testified, according to a transcript of the May 24 deposition that was released late Monday by the Center for Reproductive Rights — which has sued to force the FDA to allow over-the-counter sales of Plan B for all ages.
Crawford said he had expected the FDA would take six to nine months — "tops" — to work out the enforcement issue following his August announcement. Crawford abruptly resigned from the agency the next month; nearly nine months later, the FDA still has not announced a Plan B decision.
Plan B, also known as the morning-after pill, is a high dose of regular birth control pills. Its hormone, called levonorgestrel, prevents ovulation. If ovulation already has occurred, Plan B prevents fertilization of the egg. It also may prevent the egg from implanting into the uterus, although some research suggests that's not likely. If a woman is already pregnant, it will have no effect.
Crawford's August announcement that the decision was being delayed stirred accusations that the FDA was allowing politics to trump science. But Crawford testified that the science had concluded that it was "possible" for women older than 16 to use Plan B without a prescription.
"I made a decision that that was correct. What I could not decide on is whether or not I could stand before the American people and say this will be successfully enforced. That I could not decide," Crawford said in his deposition.
A November 2005 Government Accountability Office report characterized as unusual the involvement of high-level FDA officials in the review of the application by manufacturer Barr Laboratories to loosen Plan B sales.
Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, testified April 26 that Crawford said in January or February 2005 that he was taking over the decision on Plan B. Galson testified that he wasn't planning to approve over-the-counter sales at the time but was "tending that direction."
Crawford "told me that he was concerned about where we were heading because he knew that I was heading towards this recommendation, and he told me that he was going to make the decision on what to do with the application," Galson testified.
The Center for Reproductive Rights was scheduled to depose Crawford's predecessor, former FDA commissioner Mark McClellan, on Tuesday for his role in an earlier agency denial of Plan B's nonprescription sales.
Last year, Democratic Sens. Patty Murray of Washington state and Hillary Rodham Clinton of New York released a hold on Crawford's nomination in exchange for a pledge from Health and Human Services Secretary Mike Leavitt that the FDA would decide on Plan B by Sept. 1, 2005. Clinton later said the August delay "rudely surprised" her and Murray.
The two have since pledged to block the nomination of Crawford's successor, Dr. Andrew von Eschenbach, until the FDA decides on Plan B.