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Did Democrats Pressure the FDA Into Approving an Unsafe Knee-Replacement Device?

September 25, 2009 - by Donny Shaw

The F.D.A. says so. On Thursday the F.D.A. issued a report admitting that they bowed to political pressure in approving a knee-replacement device, known as Menaflex and manufactured by ReGen Biologics Inc., and that the pressure came from four New Jersey Democrats.

Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman put “extreme,” “unusual,” and “persistent” pressure on the F.DA. to approve the device, which has been shown repeatedly in clinical studies to fail and require patients to have another operation to take it out.

It looks like campaign money and political connections were involved. “All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey,” the New York Times reports. Campaign finance data shows that the four of them received a total of $26,000 from the company in the last election cycle. Michael Hutton, is now a lobbyist for ReGen, and in a Wall Street Journal article from March 2009, it’s clear that he has worked specifically on the F.D.A. approval of the Menaflex device.

Of course, the four members of Congress all say that they were not influenced by the money they got from the company. The money only comes out to about $6,000 each – not much compared to the million or more it takes to run a congressional campaign. But the narrative laid out here is pretty clear. Regen gives money to Congress, Congress corrupts the F.D.A. approval process. It’s hard to see how it’s not a quid pro quo, and for purposes of maintaining a functioning democracy, the appearance of corruption is just as damaging as corruption itself.

Pictured above are Sens. Lautenberg and Menendez.

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