"I am encouraged by the bipartisan nature of these efforts, and I look forward to working with my colleagues."
"the imbalance of inspection requirements between U.S. and foreign manufacturing facilities creates an uneven playing field for pharmaceutical plants in the U.S."
"Do you think that the Department must play a role? I mean, do you think that it is absolutely necessary that they play a role?"
"I think the failure of the Department to complete security plan approvals and compliance inspections is a very serious issue."
"I think that it is our responsibility to do something more comprehensive to provide the guidance, Mr. Chairman."
"I regret that this committee has not taken a more proactive approach to securing these facilities."
"I welcome today's hearing and I am very much looking forward to working together on the critical business of this subcommittee."
"PDUFA has been a remarkable success, giving patients access to safe, effective and breakthrough medical treatments."
"I think that our safety and efficacy standards are very important to the success of industry as well as to improving and protecting the health of the public."
"In fact, there is a bill, the Food and Drug Administration Mission Reform Act, that would accomplish this."
"As you know, Mr. Dingell, Ms. DeGette, Mr. Waxman and I have introduced a bill, the Drug Safety Enhancement Act..."