"There's been discussion here about a debate with the American people. If we're going to have a debate, item one on the debate should be, are we prepared to turn this over to the courts if the Congress..."
"Well, of course all that could be limited under rules that could be established by the courts for defining what amount of discovery and putting very narrow deadlines on that."
"Where massive fact-finding is required."
"But the major obstacle that you have identified, and I think very plausibly and correctly, is the time line and the amount of work and time that would be required to litigate."
"I noticed that at least two of the witnesses wanted to respond to your point."
"But aren't you troubled, Mr. Holtz-Eakin, by the enforcement issue?"
"The lack of an effective remedy would encourage, in effect, disobeyance by the Congress."
"I am going to adjourn this hearing and leave the record open for 1 week in case there are additional questions from any of the Senators."
"Demonization never makes sense in a democracy, by definition, it makes no sense because to demonize is, essentially, to shift the blame and focus it unfairly."
"the present system simply isn't working, that it's broken, and, in fact, fatally defective."
"even under existing authority, the FDA has the power to be more vigilant and vigorous in protecting the public."
"postmarket is really no substitute for fundamental reform of the entire 510(k) system."