Tuesday, July 28, 2015 10:57:43 PM
I try to keep my ranting and raving to a minimum, but if I limit myself to a couple times a year, this is worth both of them. Yes, in a fair world, the parties responsible should go to prison, primarily for their corruption of the process that didn't allow a fair debate of this important issue.
I watched a man hauled off in handcuffs to serve a few weeks in jail for stealing a $100 lawnmower. Just the fact that they illegally and unethically kept secret their plans to break their SPA agreement cost a great many millions of dollars (probably hundreds), and as I mentioned in an earlier post (#54049), the delay in full access to Vascepa will probably cost 100,000 American lives and I believe billions of dollars for no rational reason.
Sadly, though, the FDA knows that the law is written to trust them with the key decisions (such as determining what is valid new science to rescind the SPA). They can determine that the sky is green and the grass is blue, and I believe the law is written so that can’t be challenged legally.
When someone is caught doing something that is clearly wrong, two of the most common reasons are that they are evil and did it for selfish reasons, or they were too stupid to realize the implications of their actions. Evil is the worse of the two. When a guilty party is quick to plead stupid (as FDA has kind of done recently a time or two), that's a pretty good indication there was some evil involved.
I think for the FDA it truly is a mix, but they definitely committed an intentional mugging at the adcom, and wouldn't let clear (I'm sure) presentations of the facts sway them at the several appeals. In my mind, I won't let them off with a plea of pure stupidity (it's more like 50-50).
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