07/16/2014
https://www.congress.gov...
"The reason Hatch-Waxman was so essential is because there were only about 16 to 18 percent of generics on the marketplace back when we did that. Today, it is approaching 90 percent."
"Will the backlog be eliminated before the start of GDUFA II?"
"I am happy to do that."
"The generics are absolutely critical to this country and absolutely critical to our Federal budget and absolutely critical to the successful quotient and reputation of the FDA."