More Take on “Andy’s Take”

After the inaugural posting, FDA Commissioner Andrew C. von Eschenbach has posted a first substantive note on his new space on the FDA Web site. 

One doesn’t know quite what to label "Andy’s Take".  It is a sort of column I suppose.  It is a sort of blog, but not really.  A blog invites discussion and this is strictly a one-way proposition.  There is no space for any one to leave comment, and considering the number of people who probably want to have a dialog with the Commissioner, that is probably not feasible. 

In any case, in this week’s installment, he addresses the Heparin issue.  I don’t think it is fair to offer criticism at this early stage, it does after all, take a while for anyone to find their voice.  And, considering the Commissioner’s long-standing silence since he was confirmed about the FDA, a vehicle for communications is probably a good thing.  But as a communications professional I do have some thoughts about the most effective use of this space to help improve the FDA’s beleaguered image.

Talking about the heparin issue signals that he is at least willing to talk about a tough issue facing the agency, and that he isn’t trying to whitewash.  He acknowledges the FDA mistake regarding plant inspections and record keeping and then says a bit about what the agency is going to do about it.  And then, without offering much explanation as to how it is going to work, he announces a new initiative to address some of the overseas issues called "Beyond Our Borders" which he says will work "by nurturing cooperation for information sharing, improving procedures for expanded inspections, and working with private and government agencies to assure standards for quality."  That is a little vague and the FDA is very crowded with initiatives that are not well understood, identified or promoted (the Critical Path, case on point) so that the agency benefits from their existence.    

While the attempt to address a current problem facing the agency is a good thing, at this early stage it would be important for the Commissioner to give more complete insight into the bigger picture.   A sort of thinking out loud column about the fact that "the agency is in trouble, and here is what I’m going to do about it"  type thing.  What this should not turn into, is a platform whereby the agency announces what it is going to do about a problem after the problem arises.  That will make the agency look constantly reactive and that is not an image that will help them.  They need to appear proactive.  The Commissioner needs to use this pulpit to tell us how the world is changing and how the FDA is going to move beyond the current set of circumstances, and get ahead of the curve.  That will make "Andy’s Take" worth the read.   

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3 Responses to More Take on “Andy’s Take”

  1. Terry says:

    Your own expert advisory panel voted 17-0 for safety and 13-4 on efficacy for Provenge. Why did the FDA go against the panel? The one vocal member against Provenge, Dr Howard Scher, had numerous conflicts of interest where he would have lost money if Provenge was approved. Dr Scher had absolutely no experience in immunotherapies, why was he on the panel? Any truth that you were blackmailed by Dr Pazdur, where he would reveal the dirty laundry of the FDA if you approved? Why was Dr Pazdur so concerned about Provenge? Thanks for your thoughts.

  2. Kerry Donahue says:

    It would be nice if Andy gave us an update on the internal investigation of the unprecedented actions that took place within the FDA and NCI related to the failure to approve the Provenge BLA.
    The world has been awaiting this explanation for a long time.
    Andy why did the FDA over rule its advisory committee which overwhelmingly supported approval of Provenge and what has the post CR letter investigation uncovered.
    Will the FDA admit to its mistakes in the matter and address them or continue to ignore them which in turns continues to inflame the passions of the community.
    If the FDA really intends on being more transparent and more accountable then lets start with what happened with Provenge.

  3. Bix says:

    I was hoping his blog would be more informal, more like his boss’ blog, HHS Secretary Mike Leavitt’s blog. ( Even Leavitt accepts comments. They could be moderated, they don’t need a reply. Comments make a blog.
    I was a little dismayed in that it sounded like someone wrote it for him. But I think you have a point, he needs to find his voice.

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