N.J. State Senator Seeks Governor’s Support In Pressure Probe

New Jersey State Sen. Robert Singer (R-N.J.) is urging Gov. Jon Corzine to join him in asking for the U.S. Attorney’s Office to investigate accusations that four New Jersey lawmakers pressured the U.S. Food and Drug Administration (FDA) into approving a knee device after receiving campaign donations from executives at ReGen Biologics, the device maker, in 2007.

The device, a collagen meniscus implant, called Menaflex, was manufactured to guide new tissue growth using the body’s healing process to reinforce and repair the meniscus in patients with an irreparable meniscus tear or loss of meniscus tissue.

Two of the lawmakers, Rep. Frank Pallone Jr. and Rep. Steven Rothman, both Democrats and representing New Jersey, are shifting blame to the FDA for approving the device, which is manufactured by the Franklin Lakes, N.J., firm.

“We encouraged them to make a decision one way or the other, and they [the FDA] base the decision on science and safety,” Richard McGrath, Pallone’s communications director, told Medical Product Outsourcing.

Rothman said ReGen is based in his congressional district, but the FDA made errors. “ReGen is a small business based in my congressional district, and they felt that they were being treated unfairly by, and not getting clear information from, the FDA about the approval process for their product. I responded to their concerns by asking the FDA to treat ReGen fairly, communicate with them better and to render a decision based solely on the science of the matter. Today’s report makes it clear that the FDA made mistakes and communicated poorly with ReGen. The report also says that FDA never even made an effort to investigate ReGen’s claim of unfair treatment. Given this treatment from the FDA, it is understandable that ReGen reached out to their elected representatives for assistance.”

Sens Robert Menendez and Frank Lautenberg, who are the other lawmakers accused of exerting pressure on the FDA, were not immediately available for comment.