Orrin Hatch actually said...

"Simply put, PODs are medical device businesses in which a physician is both an investor and a distributor--essentially a salesperson--of either the devices or some of the components."

"FDA's proposal to regulate LDTs is a significant change that would impose considerable new burdens on regulated parties."

"One issue that significantly affects many entities in my home State is the FDA's October 2014 proposed guidance on the regulation of LDTs, laboratory-developed tests."

"If we don't allow enough data exclusivity time, we're not going to develop these therapies, especially in bio, because bio is one of four or five places, four or five techniques, where we can actually..."