Newguy, it is pay for play right now. I see it every single day of my working life. Total bull crap. About time to go back to the way things used to be done... the right way, not the money way.
Agency is supposed to look out for us, the public at large. Right now they do not. They need to put healthcare and patient safety first. Put companies that are only interested in the money side on notice. Either play or lose the US market and go elsewhere to hawk your stuff.
In some ways this is like legalizing drug cartels. Time it stopped and it needs to be done at the Federal level.