Earlier quoted context omitted.
Not being able to get a sample to prove bioequivalence is typically very easy. There are a handful of drugs that have a REMS program whereby the manufacturer is required to restrict access. We're talking maybe a few tens of drugs. And yes, drug companies playing the game of "I'm not allowed to give you a sample" is super shady and ridiculous. Wouldn't surprise me if this gets fixed super fast.
FDA could give overriding authority to oblige manufacturers to provide a sample to the generic manufacturers for drugs older than . Of course this is bad for business. Alternatively the generic manufacturer would have to run a phase 1 and 2 trial. (Skip requirement for phase 3) Expensive, but much less than full R&D.
All the gov't has to do is say "no, if a generic company requests a sample you can provide de it without violating REMS regulations".