12/04/2017
https://www.congress.gov...
"I am deeply concerned by the testimony we have heard today and the impact that similar conduct may have on my constituents."
"And it is using the notion of patient safety to delay the development of additional drugs that could bring down the cost."
"For some medications with serious safety concerns, FDA requires manufacturers to set up risk evaluation and mitigation strategies, otherwise known as REMS programs."
"REMS has really had two problems with, the first one was we as the generics, as we reverse engineer, need the product that we are reverse engineering to make that."