Alright we can call the FDA-regulations-on-top-of-capitalism thing Americaism, and say there's something wrong with that then. Because whatever part you want to blame it on, regulation bug or capitalism or corporate greed, something has gone wrong. Here's a medical technology that improves people's lives, but it's being held back from dying patients (an estimated 7% of men with depression go on to commit suicide) because they couldn't make enough money from it. I guess the real question is how could you structure regulations so as to incentivize getting FDA approval for unpatenable life-saving medicine?