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Thread: F.D.A. Reveals It Fell to a Push by Lawmakers

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    F.D.A. Reveals It Fell to a Push by Lawmakers

    New Jersey Politics. Is anyone not surprised?

    The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.

    The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

    But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.
    http://www.nytimes.com/2009/09/25/he...knee.html?_r=2

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    Re: F.D.A. Reveals It Fell to a Push by Lawmakers

    Quote Originally Posted by PogueMoran View Post
    New Jersey Politics. Is anyone not surprised?



    http://www.nytimes.com/2009/09/25/he...knee.html?_r=2


    Jeez, they sure know how to bring it from NJ

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