FDA reviewing approval of knee device

Sept. 25, 2009 at 11:04 AM
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WASHINGTON, Sept. 25 (UPI) -- Four New Jersey lawmakers deny they acted improperly in convincing Food and Drug officials to approve Menaflex, a surgical device for injured knees.

U.S. Sens. Robert Menendez and Frank Lautenberg and U.S. Reps. Frank Pallone Jr. and Steven Rothman, all Democrats, said they were merely helping a constituent company, New Jersey-based ReGen, The New York Times reported Friday.

FDA managers overruled agency scientists to approve Menaflex for sale in December. An FDA clinical trial concluded patients did not benefit from Menaflex, said Dr. David Schmidt, who participated in the trial and is the knee surgeon for the San Antonio Spurs.

Thursday, the FDA announced it was reviewing the approval because pressure from the four lawmakers and former FDA Commissioner Dr. Andrew von Eschenbach had unduly influenced the approval process.

Eschenbach has said he acted properly and the four lawmakers have said they were not influenced by the $26,000 in campaign contributions they received from ReGen and its workers last year, The Times reported.

Thursday's announcement was the first time the FDA has publicly questioned the process behind one of its approvals, questioned a former commissioner's conduct or admitted a decision was influenced by politics, the Times reported.

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