"Simplify my problem by telling me yes, that these will be closed because of the action of EPA, or no, they will not be closed because of the action of EPA."
"I regard that as a good thing, and it is an example that we can count on the law to do both of the things that the Congress wanted when we wrote the original legislation."
"You are creating a serious problem both in terms of the administration of the law and politically for the agency."
"We have made progress but we know from recent events such as the H1N1 pandemic that more must be done to ensure our Nation's readiness."
"As you know, class III devices are devices by their nature that should require a stricter review by FDA."
"Do you believe that the clinical trial standards laid out by FDA in the premarket approval process are rigorous enough to prove safety and effectiveness of class III devices?"
"Do you believe that a single study is sufficient to approve a class III device?"
"Do you believe that the current postmarket surveillance requirements are adequate?"
"Do you believe that the device manufacturers have met their responsibility to conduct rigorous postmarket surveillance to ensure the safety of their devices?"
"Way back, we had a nasty experience in this country. It related to a substance which caused problems with regard to babies given to mothers for morning sickness."
"Thalidomide."
"If the gentleman would yield, those things are called forum shopping over here."