DeCROCE CALLS ON U.S. ATTORNEY TO PROBE ACCUSATIONS THAT BOTH NJ SENATORS AND TWO CONGRESSMEN UNDULY INFLUENCED THE FDA

            Assembly Republican Leader Alex DeCroce said today the first order of business for Paul J. Fishman, soon to be the new U.S. Attorney for New Jersey, should be to determine if both U.S. Senators and two congressmen from New Jersey crossed ethical and legal bounds by exerting undue influence on the Federal Drug Administration (FDA) to approve a medical patch for injured knees manufactured by a major campaign contributor.

            “If the charges leveled by the FDA are true, the only conclusion that can be drawn is that Senator Robert Menendez, Senator Frank Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman put the interests of a campaign contributor ahead of the health of people in pain,” said DeCroce, R-Morris and Passaic. “This could be one of the worst cases of ‘pay-to-play’ perpetrated by any public official in New Jersey.

            “Every surgical procedure has risks,” he noted. “How anyone can push for approval of a device medical experts deemed to be unsafe, exposing patients to serious risks is incomprehensible to me. Menendez, Lautenberg, Pallone and Rothman must be held accountable for such recklessness.”

            The New York Times reported today that scientific reviewers for the FDA repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

            But after receiving what an FDA report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Menendez and Lautenberg and Congressmen Pallone  and Rothman — agency managers overruled the scientists and approved the device for sale in December.

            Three executive officers at ReGen, which is based in New Jersey, contributed a total of $26,000 to the four Democratic representatives beginning in October 2007, according to OpenSecrets.org.

            “The fact that the FDA has never questioned the process behind one of its approvals and never admitted that a regulatory decision was influenced by politics – until now – is extremely disturbing,” DeCroce said.

            “The content and tone of FDA report is extraordinary and shows how seriously the agency considers this matter. An investigation should commence immediately.”

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