Weekly Roundup 10-16-09

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Well partners, another week has flown by and it is cold and rainy in Washington, D.C. where health care reform has finished its umpteenth week and continues its slow progress.  My Google Wave invite arrived and I've been busy playing with that and trying to get the hang of it.  For those of you wondering, invites have gone out on a limited basis and Wave will fully launch later in the year.  And the leaves are changing and so are some people's minds.  Including the FDA's apparently.

  • FDA Posts Warning Letter to P&G, Then Withdraws It - In a curious happenstance, the FDA this week posted a Warning Letter for Procter & Gamble warning the company about Vitamin C in Dayquil and Nyquil.  The FDA then posted a non-informational release about the incident saying that the letter was posted "due to an internal systems error, and no Warning Letter has been sent to Procter & Gamble."  One wonders if there will be a future letter, however, and what kind of error would have let to such a mistake.  There must have been some high drama.  But the release contains no further information.  
  • FDA Issues Warning on H1N1 Product Purchases Over the Internet – The FDA issued a warning for consumers to "take care" in purchasing anti-virals over the Internet this week.  The warning was based on the agency's own experience in ordering anti-viral medication which, when they arrived, were found to contain nothing more than acetaminophen and talc.   Some people will do anything for a buck it seems. 
  • Grassley/Kohl Access to Generics Bill Moves From Committee – S.369 – The Preserve Access to Affordable Generics Act sponsored by Senators Grassley (R-Iowa) and Kohl (R-Arizona) got a 12-7 vote in the Senate Judiciary Committee this week.  S.369 would, in the words of Grassley, "prohibit brand-name drug manufacturers from entering into agreements with generic drug manufacturers designed to keep cheaper generic equivalents off the market" – known has "pay for delay" deals.  
  • GAO Report Says Gaps Exist in Food Safety Among Regulatory Agencies - The GAO issued a report this week that said there are gaps in the coordination of key agencies involved in ensuring the safety of imported foods.  Among other things, there is a concerning lack of coordination among computer systems that allows for failure to notify the FDA about key inspections it should be making on shipments.  
  • Sidewiki  and Pharma Update - I now have found Sidewikis on the Web sites of three major pharmaceutical companies – Pfizer, Amgen and GSK all have sidewikis on their home pages, and one product, Viagra, has a sidewiki on its home page.  

That's it for me this week.  Have a good weekend everyone.  

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