John Dingell

Do you have the authority to control the safety of raw materials or imported pharmaceuticals?

I have great concern for the tremendous amount of pharmaceutical medicines and ingredients that are coming in from abroad.

These are authorities that would be given FDA under H.R. 1483, the drug safety bill I introduced with my colleagues Mr. Waxman, Mr. Pallone and Mrs. DeGette.

How often can you get by to see a foreign drug manufacturer?

Do you have the necessary authorities and resources to see to it that drugs are only imported from facilities overseas that are properly observing good manufacturing practices--that is a word of art--yes or no?

Do you have the ability to see to it that raw-materials suppliers also engage in good manufacturing practices abroad?

More must also than done to ensure transparency and access to information for products being imported into the United States.

Do you have the resources needed to conduct foreign drug-facility inspections with the same frequency as domestic drug-facility inspections?

Do you have the authority and the resources you need to address the safety of components now being imported into this country, yes or no?

Do you need additional authorities to be effective in that?

Are today's GMPs sufficient to ensure manufacturing quality, yes or no?

I would hope that we would follow the example that we set last Congress when we worked together in a remarkably bipartisan fashion.

I commend you for the hearing today with regard to the FDA amendments that we are discussing with regard to PDUFA.

Is that sufficient or not?

If our intention here is to focus on process reform, I would urge you to be done deliberately, transparently, and with adequate participation of all affected parties.

Well, maybe we ought to fire the damned Commission if they can't come to a decision on these matters or give them more money.

Mr. Chairman, you are most courteous. I thank you for having this hearing, and I appreciate your concern for the questions before us.

That is a very real problem, isn't it?

So it hurts most everybody involved?

Now, it would seem to me that we should consider removing the draft bill's GLBA exemption as well as to include H.R. 2221 60-day backstop notification in the interests of improving consumer protection.

I stand by to work with you and the rest of our colleagues in order to report a bipartisan consensus bill.

Now, I understand the draft bill does not treat data brokers any different from other entities that collect and store personal information.

I appreciate your work on the bill so far, and I want to thank you for these hearings.

Now, Commissioner, does the Commission believe that brokers should be subject to more stringent data security and breach notification requirements than other entities that collect and store personal information; yes or no?

How much is it estimated that the closeout of Yucca will impact the Department of Energy's environmental remediation liability?