I attended the House Committee on Government Oversight and Government Reform hearing on the GlaxoSmithKline diabetes drug Avandia yesterday. It was crowded and heated, both literally and figuratively. If you are interested in watching the video of the Avandia hearing, the committee has one.
It was heated in that a good deal of time was spent talking about who knew what, when they knew it and whom they told about it.
It was crowded in that there was A LOT of ground covered.
And then also, it was hot and there were lots of people.
For the Democrats, there was a great concentration on whether or not the FDA has the authority it needs to be able to enforce post-marketing commitments. Chairman Waxman’s opening comments revealed that the way that the FDA handled the issue speaks to the need for FDA reform by giving the agency authority to enforce post-marketing commitments by companies. (By the way, there is a link here on the blog to the FDA data base on how companies have fared on their post-marketing commitments.)
For the Republican side, there was a fair amount of "foul" being called, questioning whether the recent publication in the New England Journal of Medicine (NEJM) on Avandia was calculated to promote patient safety or to create a political reaction.
Somewhere in there, they did address the role of a meta-analysis, which is the kind of analysis Dr. Nissen performed on Avandia. One member of the committee asserted that it is the role of a meta-analysis to raise a question, but not to provide an answer.
But the majority (the Democrats) focused on why the agency waited so long to act, and only acted when the NEJM article appeared, when, they said, Europe reacted sooner. They ascribed the perceived shortcoming as a result of the lack of FDA authority to enforce post-marketing studies. The take-away is clear here – there is going to be a legislative effort to beef up FDA oversight of post-marketing commitments and maybe direct-to-consumer advertising (DTC) as well.
All of those who testified, I thought, performed well. And Commissioner Andrew C. von Eschenbach’s testimony on Avandia is already posted to the FDA Web site. But for all the fuss that there was in the hearing room on Wednesday, the real meat and potatoes on the science side of things will come in July when there will be a joint meeting of the Endocrinologic Drugs Advisory Committee meeting and the Drug Safety and Risk Management Advisory Committee. That meeting will not inform us about legislative direction, but it will provide insight into the FDA’s thinking on where all this is leading for future FDA safety initiatives, not just in this category, but in all.
When the COX-2 meeting took place, the hotel that hosted had to set up overflow rooms even to the point of giving up the lobby. I’d prepare for the same thing, if you are planning to attend.