FDA review staffers have been subjected to so many requests to brief congressional staff members and supply documents that there is an “intimidating” atmosphere, according to FDA deputy commissioner Janet Woodcock.
She also told the Reuters Health Summit in November that reviewers have “a concern in their mind…about their own personal accountability for their scientific judgment.”
According to Woodcock, the time needed to respond to so many congressional requests for information is detracting from FDA’s scientific mission. She also said the probes “take a hit on morale. People feel worried. We don’t object to oversight, but you have to recognize the review staff does feel concerned.”
Woodcock also said things may be improving. “We need to show the public and Congress how we are dealing with these issues,” she said. “And I think we can move ahead.”
Congressional committees have been looking into FDA’s handling of safety concerns with GlaxoSmithKline’s Avandia and Sanofi-Aventis’ Ketek, as well as many other issues.
GlaxoSmithKline CEO Jean-Pierre Garnier told the meeting lawmakers have been “issuing critical press releases, creating unnecessary turmoil.” He said FDA should be left alone to do its job, noting “they are not immune to the pressure they are under.”
Commenting on Woodcock’s complaints, a spokesperson for Sen. Charles Grassley (R-IA), a frequent FDA critic from his position as ranking member of the Senate Finance Committee, said the senator “looks forward to the day when FDA oversight won’t be needed.”
House Energy and Commerce subcommittee on oversight chairman Bart Stupak (D-MI) told Reuters he is proud of his panel’s oversight. He said multiple investigations are necessary because “there are just so many incidents where they just are not doing their job. This is only my first year. I have not yet begun to turn up the heat.”
From the January 01, 2008 Issue of MM+M - Medical Marketing and Media
