Weekly Roundup – 4/30/10

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 It has been one busy week, not only for me personally (cross country biz travel) but on the FDA side of things as well.  Makes no sense to do anything but get started.

  • Dendreon's Provenge Finally Gets Approval - In what was certainly one of the most long-awaited and anticipated announcements from FDA I've seen in a long time and over a long career, the FDA approved Dendreon's therapeutic cancer vaccine Provenge for treatment of late stage prostate cancer.  As nearly everyone in the biz knows, Provenge had an AdComm meeting where there was a vote in favor of approval, but the FDA did not agree.  As one can imagine, a lot of drama ensued.   The approval finally came yesterday.  Reuters reports that the cost of Provenge is set at $93,000 for three infusions.  In clinical trials, Provenge was seen to increase median survival by 4.1 months.  That comes out to about $23,000 a month.  
  • Where to Put the Information on the Food Label?  That is the question.  For the FDA at least.  The agency announced this week that it would be seeking input from the public on front of package labeling and shelf tag symbols.  One hopes that at some point, someone will put time and resources into teaching people what to do with the information they get from the label, which to my thinking is actually the bigger problem than where the information is placed.  
  • Dr. Hamburg is Talking Up a Storm! - FDA Commissioner Dr. Margaret Hamburg was out on the circuit this week!  First, she gave a speech on the 22nd of April at the Food and Drug Law Institute where, among other things, she spoke of the agency's "renewed emphasis on enforcement" and returned to her theme of the FDA being a strong protector of public health.  The following day, Dr. Hamburg spoke at the US Pharmacopeil Convention where she emphasized that her vision was for the FDA to be a gateway, not a bottleneck for the development of new products (timely given the approval of Provenge).  Finally, on the 28th, she delivered remarks at the Nutrition Summit where she cited the fact that diet related chronic disease, primarily meaning obesity, "is the defining public health issue of our time." One only had to spend as much time as I did in airports this week to know she is perhaps right on the money.  In any case, reading these three speeches provides one with good insights into the FDA's mindset as to its role and how it will go about fulfilling it.  More than any time in many years, the FDA – being guided by two people whose backgrounds are steeped in public health – sees the agency as the primary guardian of public health.  Therefore, when dealing with the FDA, whether a medical product manufacturer or a member of the tobacco industry, if you are not speaking in public health terms, you are probably not going to be successful from a communications point of view.

That's it for me this week.  I'm home today wrestling with do-it-yourself furnishings to construct with little wrenches from Sweden.  Wish me luck.

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