F.D.A. Reveals It Fell to a Push by Lawmakers
New York Times
By GARDINER HARRIS and DAVID M. HALBFINGER
Published: September 24, 2009
WASHINGTON — 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.
The article goes on to say how oversight has shown that many of the Agency’s Practices have been questionable. This is a Surgical Implant Device for patching up the cartilage in the knee. It costs approx. $3,000. It was shown to be no better than normal Knee surgery in Clinical Trials.
This is crazy stuff! I’m a little slow on the uptake. Does this mean that people can vicariously pay to have their Medical Products approved by the FDA?
What do you think happened here? The article stops the Money chain at Menaflex>Congressmen. How did the Congressmen influence the FDA Boss? Threats? Blackmail? Money? Hmmnn? Maybe they just henpecked him until he finally gave in? No?