The main issue is the way drugs are regulated and priced up. In the EU (and most of the world), the discussion on regulation is tied to pricing. Part of getting clearance on getting to sell into the EU is gaining an understanding on how much you plan to charge.
In the US on the other hand, the FDA requirements are more stringent, but are disconnected from pricing completely. Achieve FDA clearance, and you can negotiate whatever price you want. US consumers subsidize the rest of the world.
In the US on the other hand, the FDA requirements are more stringent, but are disconnected from pricing completely. Achieve FDA clearance, and you can negotiate whatever price you want. US consumers subsidize the rest of the world.