Pharmalot.com reports that there are more than a thousand pages of memos, charts and studies in the Avandia briefing documents posted on the FDA web site on June 9, 2010. A committee meeting is being held this week due to internal bickering over Avandia's fate. "There's not complete unanimity within FDA about the meaning of this data," CDER director Janet Woodcock acknowledged during the same briefing. The article explains that the meeting is why the briefing documents amount to dueling studies, and the questions the advisory committee members will have to answer appear structured to allow the agency some wiggle room.
Not only are there eight questions, in fact, several questions contain an unusual feature. Instead of being able to choose just A or B committee members can choose choice C, which indicates a finding can't be made. It's a way of opting out.
The panel members are scheduled to meet on July 13 and 14 to make recommendations about what steps the regulatory agency should take to protect consumers. While the FDA is not required to follow the advisory committee's advice the advisory panel's anticipated decision, is expected to bring considerable pressure on FDA to recall Avandia from the market.