Biotech Values

[DewDiligence]

FDA revokes approval of Menaflex knee implant:

http://online.wsj.com/article/SB10001424052748703631704575552303787618926.html

The FDA's top device regulator, Jeffrey Shuren, called it an "unusual, unique" circumstance. The FDA sometimes removes devices when new safety data emerge, but it is rare for the agency to call the entire approval process flawed and redo the evaluation.

The move follows a March 2009 article in The Wall Street Journal that said a team of FDA reviewers and their manager had repeatedly rejected the device because of questions about its safety and efficacy. The article described intense lobbying and pressure on the agency by four congressional Democrats from New Jersey, home of Menaflex maker ReGen Biologics Inc.

In September 2009, the FDA released a sharply worded report saying "extreme" pressure from politicians hurt the integrity of the process. The report criticized a former commissioner and two device division leaders for their role in approving Menaflex.