Federal regulators are going to take another look at the clearance of ReGen Biologics Inc.’s Menaflex knee device. As we reported in March, Menaflex, which is meant to treat a torn meniscus, was approved even after scientists at the Food & Drug Administration (FDA) had repeatedly rejected ReGen’s fast-track application.
The FDA’s fast track process – also known as a 510K application – doesn’t require human clinical trials, and is meant for devices that are substantially similar to products already on the market. But in a March interview, the chairman of the FDA advisory committee that considered Menaflex told The Wall Street Journal that there are no other products on the market similar to the device.
The Menaflex fast-track application was rejected by FDA scientists on three occasions, with the agency’s staff asserting it wasn’t eligible for the process. But after the second rejection in September 2007, several New Jersey Congressmen appealed to FDA commissioner Dr. Andrew von Eschenbach on behalf of ReGen. At their request, Dr. von Eschenbach met with officials from ReGen, and the decision on Menaflex was subsequently handed over to the head of the agency’s device division, Dr. Daniel Schultz.
Dr. Schultz convened a new panel that at the request of Menaflex, included five sports-medicine experts from outside the FDA’s regular pool, The Wall Street Journal said. The FDA’s own scientists who had been critical of Menaflex were also barred from speaking to the panel.
Dr. Schultz ultimately approved Menaflex, citing the panel’s overwhelming support. But there was never a formal vote. One panel member told the Journal that had he known Dr. Schultz was poised to approve the device, he would have voiced objections.
Now the Journal is reporting that in response to concerns voiced by Sen. Charles Grassley (R-Iowa), FDA acting commissioner Dr. Joshua Sharfstein said in a letter that the Menaflex decision raises “legitimate concerns about whether the agency’s review process and decision…were compromised.” The letter, which was sent to the Senate Finance Committee, said the FDA would be reviewing the decision to approve Menaflex.
Meanwhile on Monday, the House Energy and Commerce Committee also asked the FDA to re-examine the Menaflex decision. Ironically, according to the Journal, one of the lawmakers who signed the Committee’s letter asking for the re-examination was New Jersey Democrat Frank Pallone. Pallone was one of the Congressmen who pressed Dr. von Eschenbach on Menaflex in 2007.
According to the Journal, Pallone maintains that he only contacted Dr. von Eschenbach to insure that Menaflex was given a fair hearing by the FDA.
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