NJ Congressmen used political influence to pressure FDA to approve faulty medical device
Senator Robert Singer (R-30) urged Governor Jon Corzine to join his call for the United States Attorney’s Office to investigate shocking revelations that four New Jersey congressmen exerted pressure on the Food and Drug Administration to force the approval of a medical device after receiving campaign donations from several executives of ReGen Biologics, the producer of the device.
In a published report, the New York Times stated: “The agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.”
“It is unprecedented for the FDA to come forward and say that the approval of a medical device was based not on science but on politics,” said Singer. “It is unprecedented for the FDA to accuse these New Jersey congressmen of putting the public’s health at risk.”
Senators Robert Menendez and Frank Lautenberg and Representatives Frank Pallone Jr. and Steven Rothman reportedly received campaign donations from several ReGen executives starting in 2007. According to the Times, the four congressmen began making inquires within months of receiving the donations. The director of the FDA’s Office of Legislation described the pressure from the congressmen to approve the device as “the most extreme he has seen.”
“Extremely serious allegations have been made that unsafe medical devices may have been approved as a result of the efforts of these congressmen,” said Singer. “After reading today’s stories, how many recipients of a ReGen device are now worried that their health may be at risk?”
The Times quotes the chairman of ReGen, Gerald E. Bisbee Jr., as saying, “We did what people do all the time in Washington: we went to our congressmen, we went to our senators.”
“The comment from ReGen’s chairman appears to indicate that he expected results for the donations to Senator Menendez and others,” said Singer. “The United States Attorney should clear the air and help ensure that politics didn’t trump science. I sincerely hope that Governor Corzine will join my call for an investigation of this matter.”
