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      Authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; issues and crisis management. Frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!

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    • Eye on FDA is published by Mark Senak of Fleishman-Hillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of Fleishman-Hillard or its clients.

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    « Weekly Roundup - 11/17/06 | Main | Happy Thanksgiving »

    November 20, 2006

    Hold It!

    J0387823_1 Senator Charles Grassley (R-Iowa) has gone and put a hold on the nomination of Dr. Andrew C. von Eschenbach.  There was movement to try to get him approved in the lame-duck Senate session, but the hold would put that into doubt. 

    According to reports, this hold is rooted in concerns about the approval of Ketek, manufactured by Sanofi Aventis.

    Maybe instead of the number of votes a commissioner gets, we should just count the number of Holds.  This makes 5 holds on this nomination in total.  That is 10% of the Senate!

    This Senate, and this Congress have been branded by nearly everyone as a "do-nothing" body.  We saw the public reaction to that a few weeks ago.  Well, no one can say the 109th is not going out with a bang. 

    The holds placed on the nomination regarding Plan B by Senators Patty Murray (D-Washington) and Hillary Clinton (D-New York) were legitimate exercises over legitimate concern about the fact that the FDA was suddenly using politics to overcome science.  Wisely, Dr. von Eschenbach saw to it that the matter was cleared up.

    However other holds placed on this nomination were solely for political objectives - one regarding importation, one regarding abortion by Senators Vitter (R-Louisiana) and DeMint (R-S. Carolina), respectively.  Now Senator Grassley's concern over Ketek's approval is the subject of a hold.  This follows on the heels of his dramatic (overly) march to HHS to demand action with cameras in tow. 

    Ketek was approved in 2004.  Dr. von Eschenbach was made acting commissioner in September 2005.  Do the math. 

    You will find this "hold" doesn't add up.

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    Comments

    Actually there are 100 Senators, so 5 is 5% of of the Senate not 10%. The point stands however.

    Well, now we know why I am not a mathematician. Tres embarassment. Nevertheless, I live by my mistakes! Thanks Antoine!

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