Orrin Hatch actually said...

"We believe these findings will say quite a bit about the lack of accountability for these types of business relationships or arrangements."

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

"While these arrangements are not always problematic, we are seeing more and more of these physician-salespeople using the very devices they sell in the surgeries and procedures they perform."

"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."