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

[ShockediSay]

http://www.nytimes.com/2009/09/25/health/policy/25knee.html

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.

All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money. Dr. Andrew C. von Eschenbach, the former drug agency’s commissioner, said he had acted properly.
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Who rules? Is it the majority of American People?
NO!

IT'S THE BIG CORPORATE LOBBIES

AND WE GIVE THEM A DOUBLE BITE INTO

OUR DEFICIT BY GIVING THEM A TAX DEDUCTION,

RIPPING OFF THE AMERICAN PEOPLE BY THE

TAX DEDUCTIONS THEY GET FOR THEIR OUTRAGEOUS

FEES

AND THEY GET THESE FEES FOR RIPPING OFF THE

AMERICAN PUBLIC BY THE LEGISLATION THEY WRITE AND

THE LEGISLATION THEY KILL.

THE WORST KIND OF LAWYERS THAT EXIST, ARE LOBBYISTS, IMHO.

AND WE HAVE THE NERVE TO SAY AFGHANISTAN

IS DEMOCRACY CORRUPTED.

[Wilms]

1. Robert Menendez got his start calling out corruption.

Gee, Bob, Musto is laughing somewhere.

[gateley]

2. Have they 'fessed up to the Rumsfeld/Reagan/aspartame deal yet? nt

[Lisa0825]

3. And it pisses me off, because I am invested in 3 biotech device stocks

which are now all delayed due to no fault of their own, because of past issues with other companies' products.

This is not just affecting the product(s) in question, but all other companies awaiting approval of their devices as well.

[bertman]

4. This is a great example of the bipartisan nature of corruption in our Congress. It

matters not if it's Democrats or Republicans, this kind of crap is wrong and deserves to be punished.

Thank you for bringing this to our attention, ShockediAm. I didn't know there was a tax deduction for lobbying.

Recommend.

[CoffeeCat]

5. UGH!!! How many other devices or drugs...

...will we discover are harmful after they've been FDA approved---simply because some corporate hacks
paid off our politicians????????????????????

THIS IS REVOLTING!!! THEY ARE PLAYING WITH OUR HEALTH AND SAFETY!!!!

Why aren't those politicians in JAIL! They serve us!!