The word on FDA from Tennessee


I am currently traveling through Eastern Tennessee and noticed this editorial from the Chattanooga Times about FDA failing to perform its mission of protecting the American People from unsafe food, drugs and medical devices. They are not the only ones to notice that the Bush Administration did FDA no favors when it came to supporting the Agency financially and politically. I like the fact the editorial mentions the failure of “third party” inspectors in the recent peanut crisis.

We need a strong, independent group of FDA inspectors who can do an unbiased job. Unfortunately I have seen some inspectors issue “FDA 483s” that weren’t worth the paper they were printed on. We need to rebuild FDA and we need to start immediately. However, FDA managers need to break out a copy of the regulations and do things “by the book.” Yes, the regulations are in desperate need of updating, but we need the necessary Congressional hearings and stick to the rule making process. A 483 shouldn’t be the product of an inspector’s imagination.

We’ll talk more of poor inspectional findings in the days to come. In the mean time I have posted the editorial under “Interesting Articles to the right. (FDA Woes…)

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