Hearing of the Subcommittee on Oversight & Investigations of the House Committee on Energy and Commerce - FDA Foreign Drug Inspection Program

Interview

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REP. GREG WALDEN (R-OR): All right, thank you. Thank you, Mr. Chairman.

I just -- my colleague from Pennsylvania, Mr. Murphy, suggested this question. I think it's a really good one and I'd like a yes or no answer out of each of the panel members.

If your child were prescribed a drug that you knew was manufactured in a facility in China that is not inspected, would you let your child take that drug?

Dr. Crosse, yes or no?

MS. CROSSE: Yes, because if they were ill enough to require a prescribed drug, I would be concerned that they take something.

REP. WALDEN: Mr. Nielsen?

MR. NIELSEN: Yes, because I don't feel there is an option.

REP. WALDEN: Mr. Hubbard?

MR. HUBBARD: We're doing it every day, so there's no choice.

REP. WALDEN: Mr. England.

MR. ENGLAND: I agree. It's -- you're left with it. You have nothing else to go to.

REP. WALDEN: That's a pretty sad commentary, isn't it? That we're putting our kids' health at risk to take drugs that our physician prescribes that we all now know are coming from factories that we don't have the resources to inspect.

That's a scary proposition, when we know our toothpaste is poisoned. We know our dog food got poisoned. And we have no options? Then we'd better change how FDA operates.

Mr. England, I want to ask you a couple of questions here. Please refer to the document from the FDA's website called "Consumer Update: Ensuring the Safety of Imported Products: Q&A with Deborah Ralston," director of FDA's Office of Regional Operations.

According to the FDA questioner, the number of imported goods that FDA regulates has more than doubled in the last five years. Ms. Ralston states on the website that the FDA has a team of more than 2,000 scientifically trained specialists who conduct inspections, analyze samples and monitor the entry of regulated products at our nation's borders.

Is this number of 2,000 FDA people working on imports a credible number?

MR. ENGLAND: I have no idea who they could be. I would think that roughly 200 -- maybe between 200 and 250 on the inspection side, perhaps another 100 on the lab side that spend more than 50 percent of their time probably is a more reasonable number.

REP. WALDEN: Ms. Ralston states that the FDA analyzes about 30,000 import product samples annually. That sounds like a big number, doesn't it? Thirty-thousand import samples.

MR. ENGLAND: It does. It does sound like a big number.

REP. WALDEN: Thirty-thousand samples is out of how many lines of entry?

MR. ENGLAND: Eighteen million probably this year.

REP. WALDEN: So 30,000 out of 18 million. Do you think that's an acceptable number when our nation's health relies on these drugs?

MR. ENGLAND: It's a remarkably small percentage.

REP. WALDEN: Do we know what kind of product samples she's talking about? Do you think a lot of these samples are drug products?

MR. ENGLAND: The majority would be food, I would expect.

REP. WALDEN: So the majority of the 30,000 of the 18 million would be food samples.

MR. ENGLAND: I would expect that's true.

MR. HUBBARD: Yeah, they sample about 20,000 foods each year. So the majority are food.

REP. WALDEN: So we're down to 10,000? I was a journalism major, not a math major, but that only leaves about 10,000 then that you estimate would be drug samples out of 18 million?

MR. ENGLAND: It could be cosmetics. It could -- and then it could be some pharmaceuticals.

REP. WALDEN: Do these analyses tell the FDA how many of the samples analyzed were safe?

MR. ENGLAND: Well, the FDA would have -- they would make a determination on the given shipments that they're analyzing. But it doesn't tell them anything about the next shipment.

REP. WALDEN: Do these analyses of these product samples generate an FDA report of any kind?

MR. ENGLAND: My understanding is that there may be some information inside the system, but it's probably very difficult, if not impossible, to try to retrieve it from the system.

So I would guess probably no.

REP. WALDEN: Would you expect that the committee would be able to attain from the FDA the results of these sample analyses what the FDA learned and what action the FDA took?

MR. ENGLAND: I would expect that they should be able to do that through its FAP system and the OASIS system, the combination of those two systems. Mr. Nielsen actually may know better.

REP. WALDEN: Mr. Nielsen?

MR. NIELSEN: Yes, I think they should be able to provide that.

REP. WALDEN: So you could provide it to us, but it sounds like no report is generated internally at the FDA for your own -- for the FDA's own use, do you think?

MR. NIELSEN: It's usually a case-by-case.

REP. WALDEN: All right. Ms. Ralston states the FDA conducted approximately 30 inspections of manufacturing processing sites in China for FDA-regulated products. How many establishments are there in China involved with FDA-regulated products?

MR. ENGLAND: Well --

REP. WALDEN: Wow.

MR. ENGLAND: It's a very large number. I don't know the answer. I know that Murray -- Dr. Lumpkin testified I think a couple weeks ago that there were 3,000 medical device manufacturers alone in China. That's just that industry, which probably is a fraction of the entire --

REP. WALDEN: Do 30 inspections a year sound like an adequate number to ensure the safety of products from China?

MR. ENGLAND: Not overall of the products in China, no.

REP. WALDEN: All right. My time is expired.

I thank the chairman --

MR. HUBBARD: Mr. Chairman, can I make one comment to Mr. Walden's earlier question?

REP. STUPAK: Yes.

MR. HUBBARD: I don't think we should leave people with the impression, though, that our drug supply is unsafe.

REP. WALDEN: It's just vulnerable.

MR. HUBBARD: It's -- exactly. I mean, I think, you know the manufacturers here to receive these foreign components do a good job under FDA supervision to screen them. So we're not, like, taking dangerous drugs every day. But as you say, we're vulnerable.

REP. STUPAK: With 80 percent of the active pharmaceutical ingredients found in drugs -- over-the-counter and prescription drugs are from offshore.

MR. HUBBARD: Right. And so clearly there's a risk. But I don't think we -- I personally don't think the drug supply in the United States -- I think it's actually the best in the world.

REP. STUPAK: Right. And in the -- I don't mean to argue or take more time, but we inspect 97 percent of the plants here in the United States every two years. They do a good job domestically, but offshore is where the problem is occurring. With 80 percent of your products coming from offshore, we have to devote the resources to offshore.

MR. HUBBARD: The manufacturers here are required, under FDA supervision, to do lots of screening before that pill actually goes to the drugstore.

REP. WALDEN: My concern is it's only a matter of time if we don't fix the inspections.

REP. STUPAK: Absolutely.

MR. HUBBARD: No, I don't disagree with you at all.

REP. WALDEN: And Mr. Chairman, could we put that document in the record? I ask unanimous consent.

REP. STUPAK: Yes, without objection the U.S. Food and Drug Administration interview, question and answer with Deborah Ralston will be entered as part of the record.

With that, we have three and a half minutes before we have a -- vote time expires. We'll be in recess. Let's still shoot for 12:00 -- shortly after 12:00. We'll continue. We still have many members who would like to ask questions of this panel. Thank you.

(Recess.)

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