Political Lobbying, the FDA, and Medical Device Approval

This post is about a very detailed case of political interference in the approval of a medical device.  The device is question is called Menaflex which was designed for use in repairing tears in the meniscus of the knee.  There are over a million repair operations per year.

I recommend that you follow the link for the full story which also includes links to documents integral to this case study.

Here is the link to the Wall Street Journal article along with an excerpt: http://online.wsj.com/article/SB123629954783946701.html#
“The recent approval of a new device to treat knee
injuries followed a lobbying campaign that overcame repeated
rejections by scientists within the Food and Drug Administration,
agency documents show.”

Duncan’s comment:  I urge you to go to the original article by Alice Mundy of The Wall Street Journal.

If you print out the article and read through it carefully you will be rewarded with a clear understanding of how political pressure can influence FDA decisions.

Truly fascinating reading for those who follow the details carefully.

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