There are bigger problems in the system hidden here. Just because a drug is off patent, does not means anybody can make it. Each potential manufacturer has to s

There are bigger problems in the system hidden here. Just because a drug is off patent, does not means anybody can make it. Each potential manufacturer has to still request and receive permission from the FDA to produce the drug. If you are exactly copying a drug that has already been proven, safe there shouldn't be much safety concerns. So the FDA approval is not supposed to test whether the actual chemical formulation is safe (as this is already proven) but that the process of manufacturing is safe and reliable. In a rational world, this should be a very quick approval. But in reality it is a very slow approval because congress and the FDA administration intentionally keep the department of the FDA that handles generic approvals understaffed. Thus there are massive backlogs and waiting lists to get a generic drug approved.