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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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    « Good Time to Move on Plan B | Main | Another Dog Bites Man Story, Big Pharma, Big Non-Profits and the Connection »

    May 31, 2006

    The Dangers of a Recess Appointment for Dr. von Eschenbach

    Related to yesterday's posting, because of the unorthodox way in which Plan B was handled, Acting Commissioner Andrew C. von Eschenbach faces the prospect of not ever being confirmed (though he actually had nothing to do with the issue).  There are senators who have put a hold on the nomination because of the way the agency communicated its actions. 

    Yet Dr. von Eschenbach resigned his post at NIH to accept this job, so he must have some degree of assurance that he will be named commissioner.  If there is some thought that the revelation by Dr. Lester Crawford that he alone was responsible for the inept handling of Plan B might move those in the Senate to take the hold of his nomination, better think again. 

    That is not likely to happen - especially given unanswered questions on the roles of others and given the fact that Secretary Leavitt made assurances to the Senate that did not come to pass. 

    The only route open to the Administration, then, is a recess appointment.  That is a move that would be highly unwise. 

    What the FDA needs right now more than anything is leadership and re-establishment of credibility.  The signal sent by a recess appointment is one of a lack of confidence as well as a near admission that the fears held by the public expressed in last week's Wall Street Journal poll are quite justified.  (See John Mack's posting on the WSJ poll.)Such a move says that

    • the Administration cannot answer the tough questions
    • there is a willingness to compound the mistakes the Administration has made with the FDA, which have been considerable, and
    • that there is little regard that such an appointment would virtually wholly diminish any real authority Dr. von Eschenbach would like to have with the public or with policymakers. 

    If the only way the Administration can make this appointment during a Senate recess, Dr. von Eschenbach would do better to return to the NIH.

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