Disclosure, Disclosure, Disclosure – Advisory Committee Conflicts of Interest

With real estate of course, it is location, location, location.  With government functionaries these days though, the key word is about disclosure.  

Fierce Biotech carried a nice overview of the recent situation that arose in the wake of the recent advisory committee meetings held to discuss the status of diabetes drug Avandia.  There you will see that two different members of the advisory committee reportedly had received payments from either the maker of Avandia or from one of its competitors.  

I, for one, am not particularly bothered by the fact that a minor payment was at some point in the past paid to someone who is a professional sitting on an advisory committee.  I find it hard to believe that a small speaking fee is going to interfere with the professional judgment and assessment of someone sitting on an advisory committee.  But I am out of fashion.  And many people will have a serious problem with it.

And for those that do, this episode may call into question the credibility of the advisory committee process.  That makes clear that the FDA is going to have to (1) look into both of the reported situations; (2) determine how it is that the payments failed to get noticed through the FDA's considerably reinforced conflicts of interest assessments; (3) assess whether there needs to be adjustment to that system, and (4) openly report on the process.

Right now, Fierce Biotech reports the FDA is looking into one of the situations, and probably will look into the other, and if conflicts are found, that will be taken into consideration as FDA completes its deliberations.  But that will not be enough.  The agency has undertaken a vast and dedicated effort to transparency and this is one situation where that effort needs to shine to maintain the highest confidence in the advisory committee system.  The FDA should initiate a process of looking into this, and report on it using the agency's Transparency Blog.  That is good reputation management.    

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
This entry was posted in Uncategorized. Bookmark the permalink.

Comments are closed.