Isn't part of the problem that the US/FDA trial and certification process is designed to be very expensive? And who benefits from a moat created by high cost of

Isn't part of the problem that the US/FDA trial and certification process is designed to be very expensive? And who benefits from a moat created by high cost of R&D if not big pharma? I seriously doubt that pharma lobby would be thrilled if costs of bringing new drugs to market suddenly fell by several orders of magnitude, so it's not going to happen.