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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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    « Healthcare Communications and the Next Ten Years - Part 4 - Communications and Risk Managment | Main | Food Protection »

    September 19, 2006

    No Holds Barred.

    J0387823 Hold it! 

    When Dr. Andrew C. von Eschenbach's nomination was going before the Senate Committee, two Senators placed a hold on the nomination pending FDA promised action on the application for the RX to OTC switch of Plan B.  They were Senator Patty Murray (D-Wash) and Senator Clinton (D-NY)

    Dr. von Eschenbach quite rationally moved the stalled application process along and the holds were lifted.  It then appeared as if he would be considered in committee this week and move on to the Senate for a vote.

    Then two other senators, Jim DeMint (R-South Carolina) and David Vitter (R-Louisiana have put new holds on the nomination of Dr. von Eschenbach, each for a different reason. 

    But not all holds are the same.

    Senator Vitter has said that he will hold the nomination until the FDA allows imports from Canada.  The merits, or lack thereof aside, the FDA has never promised that it would do so.

    Senator DeMint, on the other hand, has put a hold on the nomination based on a desire to have the FDA remove RU-486 from the drugs that physicians can prescribe - also never a subject to which the FDA had ever agreed.

    These holds are not the same as Senator Clinton's and Senator Murray's.  In each of those instances, holds were placed on the nomination because the FDA specifically said it would act on the application and it did not.

    These Senators, Vitter and DeMint, are placing holds based on their own political outlooks, but not based on holding the agency's feet to the fire to fulfill a commitment already made.   There is a great deal of difference.  Anyone can see it.  The two circumstances are clearly not equatable. 

    These holds - those of Senator DeMint and Senator Vitter are without merit and need to be lifted.  These holds are exactly the reason senators do not generally get elected president.  Senator DeMint and Senator Vitter are over reaching.  They both need a reality check, but not at the expense of the FDA.  If they want to pass legislation, then introduce it and get it passed.  But senators should not attempt to legislate by placing holds on nominations.  They know the rules.  Do it right. 

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