John Dingell

Maybe I have to raise the question of whose staff we are going to fire. Are we going to fire the majority staff or the minority staff?

That does not comfort me when you take it under advisement.

If there is wrongdoing here, by golly, let us dig it out. But let us see the whole thing.

No political appointees?

If the majority staff is making this kind of a decision, they are going well beyond their powers.

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 find myself, Mr. Chairman, somewhat distressed here.

I have heard nothing in the way of hard statements that relate to what it is this committee needs to know.

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 device manufacturers have met their responsibility to conduct rigorous postmarket surveillance to ensure the safety of their devices?

If the gentleman would yield, those things are called forum shopping over here.

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.

one of the complaints that my office consistently receives is that medical device approval process has a certain inconsistency from reviewers at the Center for Devices and Radiological Health.

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?

Now, there are some areas of improvement in the current medical device approval process but I would ask my colleagues here, does anybody remember the Dalkon Shield?

Do you believe that a single study is sufficient to approve a class III device?

the House recently passed H.R. 2112, the fiscal year '12 agriculture appropriations bill, which would cut the FDA budget by roughly 11 percent, or $285 million.

Do you believe that the current postmarket surveillance requirements are adequate?

So is there anybody around here that wants to return to what President Ford called the horse and buggy days of device regulation?

will the proposed cut have a detrimental impact on any efforts to improve reviewer training at the center?

We face huge risks. We talked earlier about pharmaceuticals that kill people and cause children to be born with flippers.

will the proposed cut jeopardize the number of review staff that FDA is able to employ at the center? Yes or no.