FDAnews Drug Daily Bulletin

CRAWFORD AGREES TO PLAN B DEPOSITION

May 30, 2006
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A suit against the federal government over the controversial Plan B contraceptive overcame a potential hurdle this week when former FDA Commissioner Lester Crawford decided to testify about the agency's decisionmaking.

Crawford had earlier refused to testify, citing his Fifth Amendment right not to incriminate himself. If he had not testified, it could have hampered the Center for Reproductive Rights' (CRR) suit because of the central role Crawford played in the agency's decisionmaking. The group is seeking an injunction requiring the FDA to approve OTC access for Plan B.

Barr first sought OTC status for Plan B in 2003, but the FDA rejected the request, saying the application lacked scientific data on the product's OTC use among adolescents younger than 16.

Crawford alone presided over Barr Pharmaceutical's OTC application for its Plan B from January 2005 until the agency postponed the review in August of that year, according to depositions taken as part of CRR's lawsuit.

Crawford was deposed for eight hours May 24, a CRR source says. The source declined to comment on the details of the testimony until the group's attorneys have reviewed the transcripts. More details should come available late next week, the source added.

Meanwhile, CRR may expand its suit to include the White House as the group considers whether to depose a former administration official that might have discussed Plan B with the FDA, a CRR source says.

(http://www.fdanews.com/did/5_102/)