Pharmaceutical Law

FDA Reviewer: Avandia Trial Was Full Of Errors
2010-07-13

Posted By: Todd S. Hageman

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. These documents can be found here and here and here.  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.

We will be monitoring the FDA advisory committee meeting closely.  We handle Avandia cases and are still accepting new cases. If you or a family member took Avandia and you believe may have suffered a heart attack or death, please contact the head of the pharmaceutical practice area, Todd Hageman, at 877-767-3108 or via e-mail.