The Day After – the FDA Avandia Meeting

 The Thursday morning quarterbacking begins!

Actually I did not attend the meetings.  I did, however, thanks to eagle eye buddy Brian Reid (@brianreid) who gave the heads up on Twitter that CNN was actually running video of the meeting (unprecedented to both of our minds), watch the voting.  It was classic FDA advisory committee meeting.  A vote is so straightforward, right?  Raise your hands.  Let me count.  But instead, the advisors had buttons to push and several questions upon which to vote.  And then they were instructed to push the button when they voted 3 times, though it would only be counted once.  After the votes were recorded, many had to clarify what they really voted for…. Anyway….

They did vote.  And the vote was telling.  Rita Rubin (@RitaRubin), who was dutifully tweeting from the hearing, reported the all-important vote to the most important question posed during the day.   (Note here is a link to the questions – this was the draft as posted on the FDA Web site and may have altered slightly, but you get the idea):

– 12 votes for withdrawal of the product

– 10 votes for marketing but with restrictions

– 7 votes for label changes to the product

– 3 votes for no changes at all

– 1 absention  

You can see that the plurality of the votes went to withdrawal of the product.  But in fact most of the votes (20) were in favor of the product remaining on the market, but with varying degrees of change to the way it is presented.  

The result left some of different opinions as to what that vote means.

And as former CNBC pharma beat reporter Mike Huckman (@mikehuckman)  pointed out today on Twitter- two different newspapers had headlines with two different outcomes reported.  The Wall Street Journal reported FDA Panel Grants Avandia a Reprieve.  The New York Times writes FDA Panel Votes to Restrict Avandia.  I noticed yesterday that as I followed the twitter traffic, there were two distinct schools of thought that were developing, so there is little surprise that the viewpoint on the outcome may be somewhat varied.

In the end, what will the fate be?  Will Avandia be pulled off the market or will it continue, but in a highly diminished capacity.  Here is the company's statement today, which indicates, of course, that it is now up to the FDA and its deliberations as to what the technical fate is of the product.  However, whatever the decision, it is important to think of it from the prescriber point of view, because if the drug is left on the market, even with some sort of label change, that is where the market will be decided.  In the end, would the prescriber choose a drug that has seen a great deal of regulatory scrutiny and litigation over one that has not?  The answer to that question, more than any other, may be the real key to the fate of Avandia.  The actual answers to the questions raised may in the end be less important than the fact that the questions were raised at all, particularly for a second time.  

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