Good grief, TB.
I'm well familiar with the process. I really did pay attention all the years I worked in the clinical trial end of things. And I'm well familiar with how much it costs to get drugs approved. But I still maintain we should not have to carry the bulk of the costs. The world lets us carry the burden because they're not willing to do so. "Oh, let the Yanks pay the price so we can get the benefit." Enough already!
And yes, the whole thing needs tweaking - a little more than tweaking IMO.
(spelling of one word corrected plus one piece of grammar-ackk!)