TRANSCRIPTS: POLITICAL LEADERSHIP CUT OUT SENIOR FDA STAFF IN PLAN B DECISION MAKING

Senior FDA staff were cut out of the decision-making process on the controversial Plan B contraceptive by former FDA Commissioner Lester Crawford beginning in January 2005, FDAnews has learned.

Both Steven Galson, director of the Center for Drug Evaluation and Research, and Janet Woodcock, the FDA's deputy commissioner for operations, were relieved of their decision-making responsibilities for Barr's contraceptive in January 2005 when Lester Crawford, who was named acting commissioner by President George Bush in February 2004, took over that role, according to court deposition transcripts.

On Aug. 26, 2005, the agency delayed its final decision on whether to approve the drug for OTC use. Crawford announced that the FDA needed time to consider whether it would be possible to ensure that only people 17 and older would be able to buy the drug without a prescription. "The FDA cannot have an inspector in every pharmacy," Crawford said during a press conference. "We would hope the pharmacies will put in a system similar to a sign-in system present for other products at this time. We cannot have the slippage between these age groups."

Crawford suddenly resigned a month later. He will be deposed May 24 as part of a lawsuit brought by the Center for Reproductive Rights (CRR) that seeks an injunction requiring the FDA to approve OTC access for Plan B.

While CRR could not be reached for comment, Nan Strauss, the group's staff attorney had earlier argued that the depositions would shed light on whether the agency makes decisions based on science or whether it is "ruled by political considerations." This decision will "focus people's attention on what is actually going on at the FDA," she added.

The FDA has been under pressure from lawmakers and advocacy groups to approve the drug for OTC use. Critics have argued that the agency has refused to allow OTC use because of political concerns that the drug's availability would increase promiscuity among teenage girls. In a February hearing before the House Agriculture Appropriations subcommittee, lawmakers accused the agency of "stonewalling" on Plan B and being overly influenced by politics. Andrew von Eschenbach's nomination to be FDA commissioner is currently being held up because of the controversy. (http://www.fdanews.com/did/5_91/)