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Menaflex Decision to get Another Look

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Questions over the clearance of the Menaflex knee device have prompted the Food & Drug Administration (FDA) to take another look at its decision.  The fact that the agency’s own scientists had rejected Menaflex three times before the head of the FDA medical device division cleared it on his own has raised concerns that politics, and not science, was a determining factor in the decision.

ReGen Biologics Inc. had sought approval for Menaflex, which is meant to treat a torn meniscus, through the FDA’s fast track process – also known as a 51oK application.  Such an approval doesn’t require human clinical trials, but it  is meant for devices that are substantially similar to products already on the market. 

When the FDA rejected the 510K application for Menaflex, scientists at the agency said it wasn’t eliglble for the process.  The head of the advisory panel charged with reviewing the application told The Wall Street Journal in March that there were no similar products on the market.

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.

After Menaflex was rejected for the second time in September 2007, several New Jersey Congressmen appealed to then-FDA commissioner Dr. Andrew von Eschenbach  on behalf of ReGen.  At their request, Dr. von Eschenbach met with officials from ReGen, and the clearance of 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.

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