01/16/2018
https://www.congress.gov...
"Senator Hatch and I will be referring information about this allegation and about possible Sunshine Act violations to the Inspector General."
"FDA's proposal to regulate LDTs is a significant change that would impose considerable new burdens on regulated parties."
"Ranking Member Wyden and I will be making a formal referral to the HHS Office of Inspector General and the Department of Justice on at least one case we feel deserves review for potential criminal act..."
"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."