The FDA has admitted that it was under a great deal of political pressure to approve ReGen Biologics Inc.s Menaflex knee device designed to repair torn meniscus.
After the FDA had rejected Menaflex for its 510(K) approval process (no human clinical trials necessary) three times, two US Senators lobbied the FDA to approve the medical device. Both US Senators from New Jersey Frank Lautenberg and Robert Menendez as well as US Reps. Steve Rothman and Frank Pallone, Jr. called the FDA in 2007 and 2008 in order to encourage them to approve Menaflex. The medical device was approved in spite of 3 previous rejections.
Due in part to the media report, the FDA is now reviewing the process by which Menaflex was approved. That process may take months but will consider whether the medical device should remain on the market.
The revelation of Congressional influence at the FDA may be surprising to some since members of Congress, especially Iowa’s Charles Grassley, have been pushing for more transparency in influence peddling regarding the approval of medical devices and pharmaceutical drugs.