Former FDA Commissioner Lester Crawford's tentative pledge not to testify about his role in the agency's decision-making regarding the controversial contraceptive Plan B could potentially derail a lawsuit forcing the FDA to approve the drug for OTC use, sources say.

Crawford is the only agency official that presided over Barr's OTC application for its Plan B contraceptive from January 2005 until the agency postponed the review in August of that year, said Nan Strauss, staff attorney for the plaintiff, the Center for Reproductive Rights (CRR). Because Crawford, a political appointee, took over for the agency staff that had previously had responsibility for this decision, his refusal to testify leaves a sizable gap in the FDA's reasoning for delaying its decision, she added.

"We are deeply troubled by the possibility that such an important matter of public health is being withheld from the public, from the watchful eye of the press and from a court's oversight," Strauss said. CRR now must determine "another way to have meaningful judicial oversight," she added.

Steven Galson, director of the Center for Drug Evaluation and Research, and Janet Woodcock, the FDA's deputy commissioner for operations, testified during April depositions that Crawford relieved them of their decision-making responsibilities in January 2005. Woodcock told CRR that she was cut out of decision-making at that time and Galson testified that he received no feedback or consultation on his recommendation that Plan B be provided OTC for women 17 years and older.

Before the group decides what its next step will be it must find out how broadly Crawford will assert his Fifth Amendment rights. CRR will not know this until Crawford's deposition on May 24, she added. "We'll have to wait and see what happens at the deposition, though, to know how this is going to play out," Strauss said.

Crawford's counsel first alerted Magistrate Judge Viktor Pohorelsky during an April 27 telephone hearing that the former commissioner would assert his Fifth Amendment right not to incriminate himself. The attorney, Barbara Van Gelder of Wiley Rein & Fielding, argued that Crawford would refuse to testify because he is facing potential federal grand jury criminal investigations into issues including Plan B and questions over his financial disclosure forms. (http://www.fdanews.com/did/5_92/)