John Dingell

What authority do you have to supervise to see to it that stuff moving across the state lines that is supposed to be supervised by the states, which can't do it, is, in fact, not something that is going to create safety problems for people?

the FDA has not been aggressive enough in attempting to regulate compounding pharmacies.

This committee should be saying what authority do you need, and then saying by golly, we are going to get it for you.

court decisions are the law of the land.

You have got these people in Massachusetts that are creating thousands of prescriptions that are being distributed all over the country, clearly to me, that are bad actors.

And good manufacturing practices are absolutely critical to seeing to it that the pharmaceuticals are safe, is that not so?

Would you submit to us what it was that they did to deny you that access?

We have a nasty situation on our hands. Let's get down to addressing the problem that is before us.

the owners and operators of NECC ran a shoddy, fly-by-night operation, and jeopardized the lives of thousands of people.

Our responsibility is to find out if the laws are being properly enforced and if there is additional law that is needed to make the situation better.

At what point does it cease to be compounding and become manufacturing?

So you don't have authority to require them to register so you know who is in the business, right?

Even in light of the fungal meningitis outbreak, with 53 deaths and over 700 confirmed cases, some of these compounding pharmacies refused to grant you access to their facility or records for inspection.

We don't have the full authorities we need in order to do the full inspections, and we don't know who they are.

I am quite outraged. Here I sit. We are picking nits and straining at nats instead of addressing what this committee should be doing.

We should be figuring out what are the problems, and then to proceed to address them.

we need to help fix that law and keep the American public safe.

They are instructed as to limitations on Food and Drug's authorities.

My old friend Hubert Humphrey once said the moral test of a government is how the government treats those who are in the dawn in life, in the twilight of life and in the shadows of life.

I think that a charge on supplemental coverage could result in Medicare beneficiaries not seeking out the services and care they need or delaying treatment or care until it is too late.

The industry has got a legitimate complaint. We ought to hear it.

I am just a poor Polish lawyer from Detroit, but I would remind members of the subcommittee that we are not engineers...

We are imposing a congressional straight jacket on the EPA and the administrators of this program.

Mr. Chairman, I thank you for your courtesy. This is a very useful hearing. It reminds me, however, of a Greek tragedy.

the situation stinks and quite honestly, the legislation is not good.