Controversial Medical Device - Menaflex - Approved By FDA
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In a bid to get a controversial knee-surgery device known as Menaflex approved by the Food and Drug Administration (FDA), ReGen Biologics relied too heavily on two consultants with strong ties to Congress and the FDA. One consultant previously worked as the FDA’s associate chief counsel for medical devices and had regular contact with the agency about the device; the device was approved last December despite staff objections. Another top ReGen consultant is the former chief of staff to Senator Robert Menendez, who was among four lawmakers that signed a letter urging the FDA to review the case. Campaign finance records also show that one of these consultants contributed about $40,000 to Menendez and the other three New Jersey politicians that signed the letter.
The two consultants were part of an aggressive campaign by ReGen to obtain approval for Menaflex, which is a surgical mesh used to aid in repairing torn knee tissue. FDA staff scientists rejected Menaflex three times, citing concerns that patients may experience adverse effects and that the manufacturer had not provided enough evidence that the device was more effective than routine surgery. However, in late 2008, ReGen appealed to Andrew von Eschenbach, the FDA Commissioner, who ordered an expedited review by a panel of independent advisers, allowed ReGen input regarding the composition of the panel and refused to permit FDA staff scientists who had been reviewing the Menaflex applications to address the panel. An internal probe found ReGen had remarkable access to von Eschenbach and approval came after he met with the New Jersey legislators who asked von Eschenbach to handle the matter personally. According to the Center for Responsive Politics, ReGen has spent $500,000 lobbying in Washington since 2007. Three of the company’s executives also gave substantial sums of money to the campaigns of the lawmakers that signed the letter to the FDA, though the congressmen’s aides claim the contributions played no role in their decision to approach the FDA.
The exposure from this ReGen case and how the FDA is now considering approving the Menaflex has alarmed not only public interest groups seeking FDA reforms, but also the $200 billion medical device industry, which is also seeking changes to health-care reform legislation making its way through Congress.