I don't know much about the regulations the government imposes on pharma companies, but I assume it's mostly to show that the new drug actually does something and is not dangerous.

I think those are reasonable. I don't want a few hundred people to die and their relatives to sue the company because it saved money on the safety checks before a drug is removed from the market. And I also don't want to go back to the time of snake oil salesmen traveling the country...