10/25/2011
https://congress.gov...
"We must worry not only about patients receiving medications that could be dangerous to them because their safety has not been established in broader populations."
"if you feel you need stronger or clearer legislation in that area, let us know because we are concerned about whatever, even a handful of devices that may be harmful."
"No one is served by adding controversial proposals to the bill. That would only serve to slow the process."
"You don't want to set up an incentive program, in my opinion, that drives developers toward the broadest market."