This is an important read from EurActiv on pioneering fast-track drug approval processes.
It seems that in both the US Europe, it is taking longer and is more costly to get new drugs approved. There are a number of spin-offs.
Firstly, as is taking longer for life-saving new drugs to reach approval, so more people are suffering.
Secondly, the extended approval process adds hugely to the cost of development and is making drug companies more risk averse.