Pennacchio: Democrat FDA Interference Crosses the Line

Senator Joe Pennacchio issued the following statement after reading news accounts of allegations that New Jersey U.S. senators and congressmen applied such extreme pressure on regulators that the U.S. Food and Drug Administration overruled its scientists and approved an unsafe, ineffective device for repairing injured knees.

"These four legislators crossed the line, and Governor Corzine should order an immediate investigation," Pennacchio said. "As a health care professional, I believe no politician should lobby the FDA unless they are absolutely certain they are acting in the best interests of patients."

All four Democrat legislators received campaign contributions from the maker of the Menaflex device, a New York Times article reported. The senators named were Robert Menendez and Frank Lautenberg, and the congressmen were Frank Pallone and Steve Rothman.

"This type of political interference puts people's health and well being in jeopardy. All surgery carries risk. If these patients need more surgery, they will now be put at additional risk. Political strong arming crosses the line and can only be described as shameful. I am calling for an immediate apology, followed by a thorough, independent investigation."

FDA scientists twice turned down applications for approval of Menaflex because they found the device didn't benefit patients and was unsafe because it often failed, forcing recipients to undergo more painful surgery and recovery. It was only after the four New Jersey legislators applied pressure that one FDA official described as "the most extreme he had every seen" that the FDA reversed itself and approved the device in December 2008, news reports say.

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