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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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    « Kennedy Enzi and the Bucks for Enforcement | Main | Weekly Roundup - 7/28-06 »

    July 27, 2006

    Dr. Andrew C. von Eschenbach Confirmation Hearing

    The Bush Administration has been in office five years.  There has been a confirmed commissioner in the office of the FDA for only 18 months out of that time. 

    The Senate Committee on Health, Education, Labor and Pensions has scheduled a confirmation hearing on Dr. von Eschenbach regarding his designation as the FDA commissioner.  Here is the information.

    Avonechenbach2_1 Title: Nomination Hearing

    Date: Tuesday, August 1, 2006

    Time: 10:00 A.M.

    Place: SD-430 Dirksen Senate Office Building

    Agenda: Dr. Andrew von Eschenbach, to be Commissioner of Food and Drugs, Department of Health and Human Services

    It is a curious time to hold a confirmation hearing.  After all, Senators have placed a hold on the nomination and we are heading to a recess for Congress.  It would seem that the hearing might an attempt to justify a recess appointment for him.

    The reason the hold is placed is because some members believe that they were misled regarding the Plan B OTC switch.  You will recall that Plan B was highly recommended by two advisory panels of the FDA.  Yet the agency ignored that recommendation and the switch has not been made despite agency assurances that there would be timely action.

    Without some expression of leadership from Dr. von Eschenbach in an Acting Commissioner capacity on the Plan B front, it is difficult to see why or how the Congress should move on this issue.  It is a radioactive issue and had nothing to do with him.  However, he did inherit it.  It is the elephant in the room and yet it has not been discussed.  Perhaps that is what he has planned as he lays out his vision for the agency.  One hopes. 

    While the tea leaves would seem to indicate an appointment for him during recess, as mentioned before on this blog, that would be a mistake.  The FDA needs strong leadership at this time to pull it from its downward spiral - which has taken it from Gold Standard to the object of reform on so many fronts.  A recess appointment would signal a crippled Commissioner - an image the agency simply does not need at this time.  It would walk around the elephant in the room, but not for long.  Dr. von Eschenbach's expertise and experience deserve something better. 

    To accompany the confirmation hearing, the agency should be engaging in a comprehensive public affairs plan - one that addresses the Plan B issues along with the other outstanding issues of concern.  It is time to acknowledge shortcomings and pull strong on the heritage of the agency.  An interim appointment won't do that.  And hearings right now, without some clarification for the misleading statements put before Congress on the Plan B issue as well as a definite plan for acting on Plan B, will not benefit the legacy someone with the potential of Dr. von Eschenbach offers the agency. 

    To read NPR coverage of this story from last spring, click here

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