September 19, 2006
FDA removes panelist amid conflict questions
The FDA has taken the unusual step of removing an advisory committee panel member due to a potential conflict of interest, The Wall Street Journal reported. The agency recently rescinded an invitation to Thomas Fleming, a statistician at the University of Washington, to serve on a committee to review the use of Factive, an antibiotic made by Oscient Pharmaceuticals, as a treatment for sinusitis. Factive is currently indicated for the treatment on pneumonia and chronic bronchitis. According to the WSJ report, Fleming had been paid $6,000 to review completed studies of Factive for a predecessor company of Oscient, in 2002 and 2003. The FDA said it didn’t have time “to resolve the issue before the start of the meeting” on Tuesday. “In order to protect the integrity of the process, the most prudent decision was to have the individual refrain from participation,” the agency said. The panel, which met yesterday, voted 11-2 against the approval of Factive’s use in treating sinusitis. The agency, although not required to, usually follows the advice of its advisory panels.