Weekly Roundup – 12/01/06

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It is a warm and balmy morning in Washington.  I slept with the windows open.  This, while most of the rest of the country suffers the effects of snow and ice – in Seattle and Dallas and St. Louis and Chicago.  Perhaps it is a metaphor for just how out of touch Washington can be…

Last week, due to Thanksgiving, there was not Weekly Roundup.  So this week, we are rounding up two herds!

  • FDA Approves Silicone Implants – In what has been regarded by many as another indication that the FDA is prepared to put science back over politics, the FDA approved silicone breast implants.   The products are manufactured by Allergan, Irvine, California, and Mentor, Santa Barbara, California.  While in the past, the implants have raised safety questions, the FDA said they have reviewed extensive safety studies. 
  • FDA Issues Approvable LetterAnika Therapeutics received an approvable letter from the FDA for its cosmetic tissue augmentation (CTA).  In the press release on the matter, the company did not say why an approvable letter was issued, but indicated final approval would be expected by the end of 2006.  The stock of the company rose after the announcement.   The Approvable Letter chart to the left under "Resources by Me" has been updated. 
  • FDA Panel Backs Celebrex for Kids – An FDA Advisory panel voted 15-1  to allow use of Celebrex to treat children for arthritis.  According to the report in the Boston Globe, however, the deliberation did not appear to be an easy one with some panelists voting "begrudgingly". 
  • Faster Pace of Approvals? – United Press International carried a story about a new report suggesting that FDA is approving drugs more quickly.
  • Grassley – von Eschenbach Feud Over Ketek Kontinues – The FDA issued a response to a request for information from the agency on Ketek made by Senator Charles Grassley (R-Iowa).  The response left something to be desired on the part of the Senator.  Dr. von Eschenbach refused to provide some of the information sought saying "the disclosure of information that might relate to any open investigation in response to congressional inquiries poses an inherent threat to the integrity of the executive branch’s enforcement and litigation functions."   The Senator holds the Doctor’s nomination and presumably will continue to do so. 

That’s it for now.  Have a good weekend everyone.

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2 Responses to Weekly Roundup – 12/01/06

  1. Adam J. Fein says:

    Mark,
    As usual, a great summary of the week.
    You forgot to mention yesterday’s injunction issued against HHS and the FDA that will hold the FDA’s planned December 1 implementation of PDMA legislation.
    I posted on the injunction this morning:
    http://drugchannels.blogspot.com/2006/11/no-pdma-for-you.html
    Regards,
    Adam

  2. Ed Vawter says:

    I posted today in more detail about the Ketek, Grassley, FDA issue.
    http://www.qdinformation.com/qdisblog/2006/12/01/grassley-the-fda-and-ketek/
    Ed Vawter
    QDIS Blog