[jonlucc]

I mean what you say in your edit. Even off-patent drugs require basic proof that they are what they claim to be, are similar to the patent drug in important ways, have a safe formulation, require a company to make a production line for it, and even require some marketing in many cases to make sure people know there's a new manufacturer of that drug.

I've never worked in generics, so I'm certainly not an expert, but I am saying both that we need some of the safety and quality controls by the FDA (or some system to replace them without relying on companies' good will) and that there are big hurdles even disregarding the FDA or other regulatory bodies.