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Panel I of a Hearing of the Health Subcommittee of the House Energy and Commerce Committee - Drug Safety Provisions of the Food and Drug Administration Globalization Act Discussion Draft Legislation


Location: Washington, DC

Panel I of a Hearing of the Health Subcommittee of the House Energy and Commerce Committee - Drug Safety Provisions of the Food and Drug Administration Globalization Act Discussion Draft Legislation


REP. DIANE DEGETTE (D-CO): Thank you very much, Mr. Chairman.

REP. PALLONE: Sorry. You have eight.

REP. DEGETTE: That's what I thought.

Thank you very much, Mr. Chairman.

I'd like to ask you a little bit about this heparin situation because, Dr. Woodcock, you had testified earlier that -- in response, I think, to Mr. Pallone's questioning -- that while it was important for the FDA to have -- to paraphrase what you said -- while it was important for the FDA to have the authority to inspect all of these foreign factories, you also felt like it shouldn't be a mandate that you inspect all of those facilities, because it would probably be better if you could put your resources on the most high-risk areas. Would that be a fair summary of your testimony?

MS. WOODCOCK: Yes. That the FDA should be given flexibility.

REP. DEGETTE: So my question is, though, if -- at least according to the media accounts -- the FDA did not inspect the Chinese manufacturer of the active ingredient in heparin, because of a clerical error. And I know there's some dispute about this, but there's some view that if it had been inspected, then we may have found the problems on an initial inspection.

What's you view on that?

MS. WOODCOCK: Well, we may have found problems on initial inspection, but we don't think we would have found contamination, because we don't have any evidence from testing that there was contamination in the heparin supply in 2004.

REP. DEGETTE: Now, aside from the clerical error, would the heparin ingredient manufacturer have been one of those high-risk facilities that you would have inspected as a matter of routine?

MS. WOODCOCK: Yes. We would have gone to --

REP. DEGETTE: Okay, great.

MS. WOODCOCK: We would have gone to that preapproval inspection. It was simply flagged --

REP. DEGETTE: Okay. So you wouldn't think that that would be a lower priority inspection. That would -- aside from the clerical error -- you would have inspected that.

MS. WOODCOCK: Well, let me clarify this so you completely understand the situation, though.


MS. WOODCOCK: The firm came online in 2004 and we did an -- it was a preapproval -- it would have been a preapproval inspection at that point.


MS. WOODCOCK: And we didn't inspect because of a clerical error.

REP. DEGETTE: Great. Thanks.

MS. WOODCOCK: But we would not have inspected, probably, subsequently to that. The contaminant, as far as we can tell, was introduced into the bulk heparin supply in China -- at least headed to the U.S. -- in many different plants in 2006.

REP. DEGETTE: Well, and let me -- let me just stop you right there. I'm sorry. I just don't have a lot of time. But that goes to some of the other questions that I want to ask. And that is: How do we catch some of this contamination that comes in along the line?

In your testimony you said that the FDA conducted 332 inspections of foreign drug manufacturers last year, which was the most ever in the agency's history. That still, however, is staggeringly low in proportion to the number of U.S. inspections that same year.

So I guess the question is: What else can we do aside -- I mean, we can increase resources, but as you say, it'll take several years to bring those inspectors online. I want to explore some other areas.

For example, do you think that we can develop a pathway so that FDA inspectors can inspect foreign facilities without advance notice or invitation from the foreign government.

This is one of the issues that we've been exploring for several years in the Oversight and Investigations Subcommittee.

MS. WOODCOCK: Yes. I'm not a lawyer, but I understand we could do that now. It's simply there are practical barriers. We have to get visas from the country. We have to state our purpose of coming in. Perhaps we could make international agreements with countries.

REP. DEGETTE: And do you think that would help the FDA in its mission of finding these problems?

MS. WOODCOCK: We like to do unannounced inspections.

REP. DEGETTE: Okay. So if there are things we can do to help you get that authority, that would be useful?

MS. WOODCOCK: Although I do believe we have the authority. There's just a host of practical problems. For example, we can't go find a plant that has shut down for a month-long national holiday and have our inspectors wait around a month till they get online again, because we need to inspect them when they're producing product. So those are some of the practicals.

REP. DEGETTE: Well, perhaps you can have your staff get back to us --

MS. WOODCOCK: Absolutely.

REP. DEGETTE: -- to see if there are some barriers that we could help you break as we look at proposed legislation.

There's a couple of other questions. On Tuesday, unfortunately, I couldn't be at the hearing because I was busy flying in. But you said that the FDA currently lacks subpoena authority and it would be helpful if you had it. Is that correct?

MS. WOODCOCK: That's what I stated.

REP. DEGETTE: And can you briefly describe how subpoena authority would benefit the agency?

MS. WOODCOCK: I would like to, but it would be better to get back to you since I'm not a lawyer; I'm a doctor. And what would help is for us obviously to be able to subpoena witnesses and documents and things like that to aid in our investigations. But as far as --

REP. DEGETTE: But you've been advised by your legal counsel --

MS. WOODCOCK: Correct.

REP. DEGETTE: -- that it would be helpful to have subpoena authority.

MS. WOODCOCK: I have been advised by our compliance experts.

REP. DEGETTE: Okay. I understand that historically your inability to copy and retain a firm's records during an inspection has been a problem. Would it be helpful if you had clear authority to copy and retain records?

MS. WOODCOCK: I don't know the answer to that question.

REP. DEGETTE: Okay. I would appreciate it if you could get back to me as we develop the legislation. Some of us think the bill probably needs to be clarified on that point. And I will tell you, I am a lawyer, even though I'm on inactive status, and it is helpful if you can get documentation as you go forward and be able to retain it.

One last question is -- and you mentioned some of this, but I want to talk about the new FDA office in China for a second. I'm assuming that having foreign-based staff would help improve some of the current issues with foreign inspections like the language barriers, cultural barriers, insufficient time for thorough inspections.

But I'm wondering if the new FDA office in China will facilitate sufficient changes within the inspection process to ensure that the inspections are adequate in nature and on par with domestic inspections. Is that the goal of the FDA?

MS. WOODCOCK: Certainly we want to attain that. However, having an office in China, although it will help with the issues you raise --


MS. WOODCOCK: -- will not put the resources against doing the every-two-year inspection, which is the goal domestically is to be -- not just do a pre-approval inspection of a plant, but be in that plant every two years.

REP. DEGETTE: And so what would help us meet that goal --

MS. WOODCOCK: That requires --

REP. DEGETTE: -- for the Chinese manufacturers?

MS. WOODCOCK: That requires, as I said on Tuesday, additional resources to have more inspectors.

REP. DEGETTE: Okay. And will the FDA officials in China, with this office, now be able to perform unannounced inspections?

MS. WOODCOCK: Well, potentially they could. As I said, my understanding is that FDA has the authority to do that. However, China is a very big country, and we're talking about a small office of FDA officials. It isn't to address the entire problem of --

REP. DEGETTE: Well, so I'm confused, because you say that you think unannounced inspections are important. You say that you think you have the authority, but what you're saying is you're not so sure you're going to do it because the office is small.

MS. WOODCOCK: I just believe there's a resource issue in covering all the facilities in China.

REP. DEGETTE: Right. So you're saying you don't think you're going to do unannounced inspections or you're going to try to do them, or what?

MS. WOODCOCK: It would increase the probability of us being able to do any given inspection on an unannounced basis.


Thank you very much, Mr. Chairman.


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