That's the nature of the life science industry. Technology is expensive to develop and commercialize.
I referenced Balco because they were trying to do it cheap.
That's not the way to endear yourself to government regulators. Nor should it be.
If your product needs to overcome an $800 million wall it's less than perfect competition.
That cost is for a new molecular entity and includes a lot of things like opportunity cost. The costs are high because the FDA is all about covering it's ass. It's not about protecting big pharma.
This may sound radical but we should do away with the FDA and rely on Civil Law to protect us from poisonous drugs
The FDA, at least on the drug side, is a bureaucratic behemoth that needs reform. However, it's a hell of a lot better than what existed before.
Phen Phen was taken off the market because 1% of the population had a bad reaction to it. That's nuts.
The FDA makes a lot of bad decisions on drugs that help more people than they hurt but this was not one of them. It's clear that Fen-Phen is responsible for the development of heart valve disease and there is no telling how many more would have been hurt if it had been left on the market. There are a lot of other anti-obesity treatments so pulling Fen-Phen was an easy decision.