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FDA Follies, Part 1
Coach is Right ^ | 4/29/15 | Michael D. Shaw

Posted on 04/29/2015 9:24:38 AM PDT by Oldpuppymax

Regular readers of this column are aware that I am no fan of the Food and Drug Administration (FDA). Let’s examine the agency’s official mission…

Here’s the first paragraph: “FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”

Good stuff. But now, take a look at the second paragraph: “FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.”

That second paragraph, and the third and final one portraying FDA’s duties as playing “a significant role in the Nation’s counterterrorism capability,” surely qualify as mission creep. Further analysis, though, is necessary.

For starters, there is a prohibitive dissonance between “assuring the safety, efficacy and security of…drugs” and “speed[ing] innovation.” Perhaps no better example exists than the relatively recent travesty involving a series of TZD meds (thiazolidinediones) in the dubious and over-promoted domain of glycemic control. You might have heard of Actos, Avandia, and Rezulin.

First up was Rezulin, fast-tracked by FDA, and withdrawn from the market in 2000, in the wake of scores of liver failures and deaths. No worries, though. We were told at the time that Avandia and Actos “[O]ffer the same benefits as Rezulin without the same risk. We are now confident that patients have safer alternatives.” Except Avandia was taken off the market in 2011...

(Excerpt) Read more at coachisright.com ...


TOPICS: Food; Government; Health/Medicine; Science
KEYWORDS: drugs; ecigs; medicines; tobacco

1 posted on 04/29/2015 9:24:38 AM PDT by Oldpuppymax
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To: Oldpuppymax
I don't see the FDA's mission anywhere in the Constitution. It's time fire some of these federal agencies.

Return the federal government to the tiny little constitutional box it came in.

/johnny

2 posted on 04/29/2015 9:43:54 AM PDT by JRandomFreeper (gone Galt)
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