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Friday, October 09, 2009
How Government Keeps You Safe
The FDA at its finest:
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.
Posted by PUBLIUS on October 9, 2009 | Permalink
Comments
Come on Publius. We all know that all the system needs is a little tweeking. Don't throw the baby out with the bathwater ... ;)
Posted by: Charles | 2009-10-09 10:06:55 AM
Oh dear, and I thought government bureaucracies were there to keep us safe and well, especially those involved in health care....
Posted by: Alain | 2009-10-09 11:38:03 AM
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