Weekly Roundup – 12/12/08

There are only 13 shopping days left until Christmas.  The lengthy process of building the scaffolding for the Inauguration continues.  The weather has been dreary and the economic forecast, humbling.  

And here is a little bit of what happened in our corner of the world.

  • PhRMA Issues Revised DTC Guidelines – In a move that has been regarded by many as "too little, too late" PhRMA has updated its DTC Guidelines.   There is nothing wrong or inappropriate with the Guidelines, and in fact, they are good.  But one can't help wondering if the industry isn't being a bit of an ostrich when it comes to the level of reform they are facing in the coming Congress and how much it is going to affect the marketing of pharmaceutical, biotech and device products (See my series, the Changing Landscape, Part 1).  
  • For Foodies, a New Resource – For those who follow food issues, a colleague of mine, Susan Finn has started a new blog that aims at presenting a viewpoint on issues related to food and nutrition from someone with a practical and solid background.   Dr. Finn is a past president of The American Dietetic Association (ADA) , the world's largest organization of nutrition experts, and the current chair of the ADA Foundation.   The blog is called "Nutrition Viewpoint, Perspectives on Food and Health" – check it out.  
  • Pain Therapeutics Receives Complete Response Letter for Remoxy –  In the wake of a joint advisory committee meeting of two committees, Pain Therapeutics received a Complete Response Letter from the FDA for Remoxy, an abuse-resistant controlled-release form of oxydocone.   The press release issued by the company stated that the agency was requiring non-clinical data, which following that advisory committee, most probably means that the FDA is centered on issues related to the REMS program.  It will be interesting to see if the subject of the advisory committee the day after Pain Therapeutic's meeting, which was for Alpharma Pharmaceutical's EMBEDA (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules, will fare any better.    

That's it for me this week.  Happy shopping everyone.   

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