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FDA Admits to Lawmaker Persuasion

The FDA admitted to Congress having a hand in approving a patch for injured knees last year.

Four New Jersey congressmen overruled scientists' concerns that the patch was "extreme" and "unusual" and approved the device, known as Menaflex. Menaflex is a C-shaped pad used to repair a torn or damaged meniscus, the cushion between knee bones. A clinical trial of the device failed to show that it worked any better than routine surgery. Researchers were also concerned over Menaflex because the device often failed, forcing patients to receive a secondary operation.

This case is the first time in FDA history that the agency has openly questioned its decisions and approvals, as well as the process for making both. It has also "never admitted that a regulatory decision was influenced by politics and never accused a former comissioner of questionable conduct."

"The F.D.A.’s report said that its Office of Legislation began receiving calls from members of Congress in December 2007 complaining about its review of the device, and the office’s director “described the pressure from the Hill as the most extreme he had seen.”

While the FDA has obviously erred (or at least some factions of it), the agency can also be applauded for its attempt with transparency. The agency isn't hiding its flaws; rather, it is unveiling the wounds hidden underneath the bandages, allowing for raw air to work its magic.

To read the full article, click here: http://www.nytimes.com/2009/09/25/health/policy/25knee.html?scp=1&sq=September+25+2009&st=nyt

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Location: Portland, OR
Sean Wolverton
I've been AllMed's Marketing Communications Specialist since May of 2007. My main duties are the updating and moderating the website, and creating the monthly newsletters called PeerPoints. Outside of work I enjoy playing golf on the weekends, snowboarding, and exploring Portland.