Weekly Roundup – 11-20-09

CG54
Ok, I'm two days late and a dollar short.  It was busy last week.  And then there is this thing called my job, which someone actually expects me to do, at least now and then.  But some interesting stuff went down this past week or so and here is what caught my eye (on fda):

  • Resource on FDA's Social Media Meeting From Fabio Gratton (@skypen) – The erudite, smart and fun Fabio Gratton (who is also now my newest BFF), has put together an incredible resource for those seeking information about the FDA's Part 15 Meeting on Social Media held week before last.   This site – www.fdasm.com – contains everything and anything that is public about the meeting – including links to the FDA site, the docket, videos, pictures, articles and all tweets.  It was not only a truly inspired bit of brilliance on Fabio's part to put this resource together, but in fact, its very presence and the accompanying high level of participation, should signal something very important to the FDA itself.  In some respect, this site is more important than the FDA docket and FDA's DDMAC would be remiss not to grasp that.  Unfortunately, DDMAC has missed a lot of what's important – hopefully that is changing.  Hey DDMAC – read the stuff on Fabio's site.   
  • Care To Live Activists Press Onward – Last week, I wrote a piece about the nature of  political pressure to change a decision by FDA – and now an update on that front.  After Dendreon's candidate product Provenge was turned down by FDA after a thumbs up by the Advisory Committee reviewing the application, activists have pressed to make transparent the process by which the decision was made internally.  Ed Silverman at Pharmalot reports that the group is appealing a court decision siding with the FDA's lack of transparency on this front, ironically after the launch of the FDA's new transparency initiative.  The PDUFA date for Dendreon looks to be May 1. 
  • Covidien Gets Extended PDUFA Date from FDA on Opioid ER Product – The candidate product Exalgo was given an extended PDUFA date by FDA, the company announced.  The FDA has been grappling for a long time – a very long time – a very, very long time, about the risk programs (REMS) associated with opioid products.  But one has to wonder if, in this decade of extreme risk aversion, in the case of pain, benefit has not been entirely sacrificed by FDA on the alter or risk.  There are literally people dying to get more pain relief.  Yet the FDA has been holding back approval on a number of new pain treating options, causing some to even leave the approval process entirely after getting a Complete Response Letter, despite efficacy.  Is that really responsible, or has the agency just gone too far?   

Ok, that's it for me this week.  It is a beautiful Sunday morning here in Washington and I hope it is wherever you are as well. 

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