Posts Tagged ‘ ReGen ’

Menaflex: Influence Peddling at the FDA

October 22nd, 2010. By Hunter West

The revelation last week that the US Food and Drug Administration (FDA) would rescind a product previously given FDA approval, is yet another example of why the FDA needs to be overhauled from the ground up and the top down. 

That’s because, according to a report October 14^th in The New York Times, a medical device roundly criticized by the FDA’s own scientists and reviewers was approved by the agency largely due to political pressure (read lobbying) and the intervention of the former FDA Commissioner. 

Worse, it appears as though this situation was one “of several” at the agency in which outside forces were allowed to be brought to bear over the FDA’s own good scientific counsel. 

And this is the agency that ensures the drugs we take, and the medical devices we use are trustworthy? 

Oh…my…God… 

The issue is over Menaflex, an implantable knee patch manufactured by ReGen. According to an FDA report launched to investigate undue outside influence in its own agency, it was determined that the Menaflex product was given FDA approval in spite of the repeated, and unanimous declarations of FDA reviewers that Menaflex did not meet the criteria for approval. 

It should be noted that the FDA employs a fast-track route for approval if it is determined an Read the rest of this entry »

Tags: FDA, implantable knee patch, Menaflex, NJ, ReGen
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