However, the drug’s manufacturer,
ReGen, which is based in Hackensack, N.J., gave four New Jersey congressmen a
total of $26,000, which was followed by calls from the members of Congress to
the FDA complaining about its review of the device. The congressmen all say
they acted appropriately.
The FDA is now acknowledging that
its former commissioner gave in to the pressure from ReGen, and began calling
for an expedited approval process for the device, which was eventually approved
in December 2008.
On Wednesday, the FDA asked the
Institute of Medicine, a non-profit medical guidance and analysis organization,
to review its procedures for approving drugs and medical devices. The Institute’s
report was extremely critical.
This case strikes a chord with many
other recent FDA cases in the past that GAP has been involved with. Although
not directly involving congressmen, GAP
client Dr. Victoria Hampshire was subjected to a smear campaign, aimed at
discrediting her, by drug behemoth Wyeth Pharmaceuticals with the help of FDA
senior officials. Why? Because Hampshire was assigned to review one of Wyeth’s
profitable animal care products, and recommended it be taken off the market,
after she found it had killed over 500 canines.
I am beginning to really lose all faith and credibility in the FDA. It seems to me that instead of focusing their efforts on protecting the general public they are in-turn being influenced by corporate agenda and special interest. I take everything they say with a grain of salt.
Posted by: e cigarette | February 11, 2010 at 03:40 PM