The question for makers of such devices, according to Potter, becomes how to support an enormous range of standards and how to agree on generic technologies.
In 2009, he is trying to do this again with a bill that calls for the same standards to apply to another category of generic drugs that wasn't included in the original Hatch-Waxman law.
An even bigger threat may come from Asia, Africa and Latin America, where relatively large drug firms make copycat pills that are legal in their own countries but fail to meet the standards of safety and efficacy that the U.S. applies to generic and branded drugs.