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

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

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REP. DIANA DEGETTE (D-CO): Mr. Chairman, I have a brilliant opening statement that I'd like to submit for the record in the interest of having extra time for questioning.

REP. STUPAK: Very good.

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REP. DEGETTE: Thank you. Thank you, Mr. Chairman.

Well, all of you testified that the FDA needs increased resources to inspect these foreign facilities, and I certainly agree with that. But I don't think it's just an issue of resources, because you also testified that the current computer -- I think Dr. Crosse in particular testified that the current computer systems are inadequate for cross-referencing and determining the various facilities abroad.

So I'm wondering if you can comment how much of the problem is more resources, and how much of it is an inadequate computer system, and what can we do to get the FDA to update their computers?

MS. CROSSE: Well, I think it's both. I think part of the resource issue is resources to update their information technology systems, and that the resources have not been devoted to that, and there was some testimony about plans that they had had that were scrapped largely because of a lack of resources.

REP. DEGETTE: But do you think there's a commitment on the FDA's part to -- a recognition that their IT systems are inadequate and a commitment to improving those systems?

MS. CROSSE: I believe that there's a recognition that their systems are inadequate. I think that you should -- the question is better asked of others whether there's a commitment.

REP. DEGETTE: All right, let's hear from Mr. Hubbard.

MR. HUBBARD: I would say that the -- I saw the import folks and the regional affairs folks ask for funding over and over again through the budget process for these systems, going all the way back to your hearings of the 1980s. And that money was always denied, and in the current administration, they had this theory that too many IT resources were being wasted and FDA was being constantly squeezed on IT, when IT actually saves you money in the end.

REP. DEGETTE: Right.

MR. HUBBARD: I hope that Dr. von Eschenbach and others will describe how he's committed to fixing that system now, but money is clearly the reason that they don't have it now, in my view.

REP. DEGETTE: Well, another thing that we could do with money, aside from improving the IT systems, is improve the system of inspection that we have. Dr. Crosse testified, and she briefed us yesterday on this pathetic system they have for actually inspecting the overseas facilities, where they take a volunteer, and the volunteer goes into this factory, and then the volunteer doesn't even have a translator.

I can't imagine how you could get any adequate information inspecting a facility when you didn't even have someone to translate for you, especially if it's a foreign facility that has a vested interest in not providing and willfully withholding information.

I'm wondering if you can comment a little further on that, Dr. Crosse.

MS. CROSSE: Well, we certainly think that's a concern. When they have a need for translation services, they are in general relying upon a representative of that establishment to do the translation for them. I have talked with some of the folks from FDA's Office of Regulatory Affairs, and they indicate that they believe there are many items they can look at, they can still physically inspect the plant and see whether there are, you know, leaking pipes and other sorts of problems, that some of the data they need to review is numeric.

But some of the data they need to review is not numeric, and some of what they need to obtain has to be gathered through interviews and discussions with officials there in the facility. And so I have a concern.

REP. DEGETTE: And they're relying on translation by representatives of the officials at the facility.

MS. CROSSE: That's right, and they're relying on that facility having an understanding of what's expected out of our regulatory system.

REP. DEGETTE: And as counsel just told me, he was in a factory in China, and they wanted to talk to some of the employees and the State Department representative who was with them said, you know, what the translator is saying these people are saying, they're not saying. And you would have no way to know that if you were just some FDA inspector standing there, right?

MS. CROSSE: Correct.

REP. DEGETTE: And that's a place where resources might help. Does the FDA, in your opinion, acknowledge this problem, as well?

MS. CROSSE: They have been reluctant to acknowledge this as a problem to us.

REP. DEGETTE: Does anyone else have a comment on the whole inspection process and how it can be improved?

Mr. England?

MR. ENGLAND: I would just note anecdotally a number of weeks -- actually, a number of days ago I was on the phone with somebody in the FDA, and that happens to be one of the foreign inspection cadre participants who's done inspections quite a number of years for FDA's foreign inspectors. And recounting, you know, they have a short period of time to get to in country, it may be a long trip. They're tired when they get there. They have a couple of days to do an announced inspection, maybe two or three days, which that same inspection, if there was problems identified, which there probably will be, in the foreign inspection, would probably be stretched out to 10 to maybe 14 days. And then they have to get on the train or a plane, get the next one. By the end of several weeks, now they're going back to their notes and trying to rebuild the inspection and do their inspection reports.

I mean, I think all of those kinds of things, those add to the complexity of just even the current system that FDA -- add translation, add the fact that the volunteers are doing, that it's announced. Many times, the inspector is relying on the inspected firm for transportation between locations.

REP. DEGETTE: Right. Now when the FDA inspects local or domestic facilities, it can arrive unannounced, it has more enforcement ability over domestic than foreign countries, and it doesn't have to have things translated. And I'm wondering if we need to beef up our foreign inspections, realizing that these are all impediments.

Dr. Crosse?

Or Mr. Nielsen?

MR. NIELSEN: I think that's very obvious. I mean, there has to be a credible presence in the industry to give the incentive to comply for those provisions that do result in safe products. There has to be a credible presence.

REP. DEGETTE: And one last question. Dr. Crosse's -- the GAO findings are that the current U.S. firms are inspected every two years by the FDA, correct?

MS. CROSSE: The data that they provided to us show that they actually get there about every 2.7 years.

REP. DEGETTE: And there's no law defining the time between inspections for foreign firms, and in fact, the foreign firm inspection, because of FDA's reliance on volunteers and so on, is much more sporadic than domestic, is that right?

MS. CROSSE: That's correct.

REP. DEGETTE: So I would think it would make sense to require that foreign firms shipping drugs to the U.S. be inspected at least as frequently as U.S. firms. Would you not agree with that, Dr. Crosse?

MS. CROSSE: I think there's certainly every reason to believe that the risks abroad are the same or greater than the risks in domestic establishments.

REP. DEGETTE: Would the rest of you agree that we should have at least the same type of inspection system we have for domestic firms?

Mr. Hubbard?

MR. HUBBARD: Well, I think it would be meaningless without the resources. They can't do the current statutory requirement of every two years. If you impose that on them for foreign, they would simply fail. So you would have to have some sort of provision to make sure that they had the resources.

REP. DEGETTE: Well, obviously you can't do the inspections without the resources, but don't you think that we need to have some kind of a standard for the foreign inspections, especially in light of the recent revelations that we've had from China and other countries?

I mean, we're not even talking here about drug counterfeiting. We're not talking about drug re-importation from the Internet. We're talking about legitimate drug ingredients that are used for FDA- approved drugs. And we're not even able to inspect them, because we don't have the resources to inspect them like we do domestically.

That seems like a backwards system. That we should really be focusing on the foreign producers -- and obviously domestic, too -- but it seems like we shouldn't say well, we're not going to inspect foreign because we don't have the resources.

MR. HUBBARD: Well, you're absolutely right. It's indefensible that we would be doing the domestic firm so frequently and the foreign firm so infrequently. But again, FDA's got to be given the wherewithal to actually do that.

REP. DEGETTE: And do you think they have the will to do it, if we gave them the wherewithal?

MR. HUBBARD: I would certainly hope so.

REP. DEGETTE: Mr. England?

MR. ENGLAND: I would note that the worst-case scenario, the equivalency is made between the domestic and the foreign industry, as far as the frequency of inspection. Without resources, what that would at least force is a shifting of existing resources towards risk -- force a risk assessment with regards to foreign versus domestic, because in these foreign manufacturers, many times these countries are developing countries; they don't have a regulatory regime like we have in the United States. They may not have potable water, at least in the community. The hygiene could be deficient.

So I think the risks, if you were to actually lay them side by side, the risks would be greater in the foreign market, and I think it would at least force that shift into the foreign market.

REP. DEGETTE: Thank you. The chairman was right, this was a wonderful panel, one of the best I've seen in my years in Congress. Thank you for your testimony.

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