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Panel II 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 II 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. PALLONE: And we're going to move to the second panel. Now let me explain that we expect votes about 12:15 so I'd like the second panel to come forward. If the votes are a called, then we won't complete your opening statements and, you know, we'll just complete them when we come back, and then do the questions as well. But we're going to try to move forward with the second panel and hopefully complete at least the opening statements before you -- before we have the votes. So if you could all come forward please.

As you can see, we have a large number. It's hard to squeeze in. We'll do the best we can. And let me welcome all of you and go from my left to right to introduce each of you.

First, on my left is Dr. William K. Hubbard, senior adviser to the Coalition for a Stronger FDA. And then next to him is Ms. Lori Reilly, who is vice president of policy for PhRMA, the Pharmaceutical Research and Manufacturers of America. And then next to her we have one of our colleagues, Congressman Greenwood, who is now president and CEO of the Biotechnology Industry Organization. Thanks for being here today.

And next to Jim Greenwood is Ms. Christine Mundkur, who's chief executive officer of Barr Laboratories. And then we have Mr. Ron Bone, who's senior vice president, distribution support, for McKesson Corporation out of San Francisco, California; and then Mr. Kevin Nicholson, who is both a doctor and -- well, a Ph.D. and a lawyer -- that's an interesting combination -- vice president for pharmacy regulatory affairs for the National Association of Chain Drug Stores. And then last is Ms. Ami Gadhia, who's policy counsel for the Consumers Union.

As I said before, we have five-minute opening statements. Those statements will become part of the hearing record. Each witness may, at the discretion of the committee, submit additional brief and pertinent statements in writing for inclusion in the record. And we'll start with Mr. Hubbard


REP. PALLONE: Thank you, Ms. Gadhia. And thank you, all the panel.

We'll start taking questions, and I'll recognize myself for five minutes for questions.

I wanted to start with Mr. Hubbard. In your testimony, you mentioned the heparin incident. Obviously that's a grave concern to us and should never -- obviously we don't want it to happen again. In some of the meetings we've had with pharmaceutical manufacturers, they've pointed out that regardless of increased inspections, we currently do not have the technological capabilities to actually prevent similar incidents as the heparin case.

And actually, in her testimony on Tuesday, Dr. Woodcock pointed out that, and I quote, "conventional laboratory testing did not identify the contaminant" and that the agency had to develop a new test. But they had to know what they were looking for something that shouldn't have been there.

So basically the way I understand it, Mr. Hubbard, the industry is saying that they can't test for unknowns that are unknown. They've got to have some idea of what they're looking for. So is it possible to screen drugs and biologics for unknown contaminants? And, if not, what else can be done to ensure that the drugs sold to the American people are truly pure and safe?

MR. HUBBARD: Well, it's certainly difficult to look for something that shouldn't be there. And we saw it with melamine last year. But I think this case points up the fact that we've got to find a way, because if people can do this kind of contamination so easily, save so much money and get it into our system without being caught, there has to be a way.

If widespread use of capillary electrophoresis or these other sophisticated technologies are going to be difficult, it may have to be -- so be it. But I would hope that you'd have a magnitude of scale that if you had more testing along these lines that you would be able to have some cost savings.

Plus if FDA is regulating more and enforcing its GMTs, you're going to presumably raise the standards generally and deter these folks anyway. And so you're going to have your supply chain where whoever put that chondroitin in at some point will know there are more people looking, there's more testing, there's more overall quality assurance.

So I think you've got the two cases. You've got a stronger system and perhaps some testing. Maybe you don't need to test everything, but I think that some testing is probably going to have to be necessary.

REP. PALLONE: No, I appreciate it. I understand what you're saying, which is that, you know, we have to try to check things through the chain and set up standards. It's not just a question of a test at the end. But at the same time, we have to try to maybe invest in new testing methods too. You just can't give up.

Let me ask Ms. Gadhia. I wanted to ask you a question about the country-of-origin labeling. You mentioned it. And, of course, a number of the other panelists voiced their concerns about country-of- origin labeling. The most common argument we've heard is that knowing what country the drug was made in or where the ingredients came from would only make consumers more worried and confused about the products they're purchasing.

Is this country-of-origin labeling important? And why? And, you know, what would you say about the industry's concerns?

MS. GADHIA: Well, I understand. And I've heard those concerns. Generally speaking, the approach that we take is that consumers are better served by more information rather than less. And, in fact, we think that the internal customers within the supply chain system would also be served by the internal information on the packaging or on what have you, letting them know where the product is from.

The way that things like herapin, for example, work, it's not something that the consumer takes off the shelf themselves. It's something that the purchasing manager within a hospital would buy, or something like that. And we'd like to see the awareness of potential red flags or danger or safety issues to go to those consumers, so to speak, as well. So we think that everyone across the board would be better served by that kind of information.


I wanted to ask Mr. Bone one more question here. You said that McKesson, I guess, has the electronic tracking system, right? You mentioned that. And you mentioned in your testimony the need for interoperable technologies to track and trace pharmaceuticals across the supply chain.

We've heard today about concerns with respect to technology -- at least in its current state, to be able to actually accomplish what's set forth in the bill that we have. And I know that the term "interoperability" is used often with respect to health information technology and EHRs, yet really doesn't mean that the systems truly are interoperable.

So, I guess what I wanted to ask you -- you know, I know that even like in hospitals, because I visit them all the time, they struggle to connect with other providers in the region or the nation. And a lot of times the technologies don't work the way they're supposed to. There are significant concerns about radio frequency identification, and, in your opinion, is the technology there yet? And are you confident that if each pharmacy purchased a different system your suppliers will be able to integrate seamlessly with each other?

Just basically tell me what McKesson is doing to ensure that their systems are truly able to connect seamlessly with all other technology manufacturers out there. You should know we're probably going to deal -- you know, we're going to deal with a larger HIT bill in this subcommittee too, in the next few weeks, so, obviously, this is of concern. If you want to just comment, if you will?

MR. BONE: So, what's happening in the industry -- and I do serve on two leadership groups that are working on the standard for track- and-trace, both domestically and internationally -- so, we're building the backbone for those standards. They are not specific in saying that you have to do it precisely this way, meaning you have to use RFID. There are other ways that you can communicate that information, and one of those is using a bar code. We have a bar code that's more robust, it's a 2D bar code that a number of manufacturers are looking at.

In the work that we've done so far in the standard-setting, we actually are recommending that if an RFID chip is on that, that it be backed up with a bar code. That means that you would have -- for those who say, I'm not technologically sophisticated to be able to do that, and, quite frankly, I think reader costs, et cetera, are going to come down dramatically, but people (who ?) could say that at this juncture -- that they would have something more akin to what they're using today, which is a linear bar code.

Now this is a bar code, kind of, on steroids. It's a more sophisticated one because we have to have more information on it. We're working on that. There's manufacturers that are experimenting with that piece. We've actually been moving RFID product for over two years now -- almost three years, where we've been testing with some manufacturers on that piece.

So there is more work to be done. That's why I like the timing of this bill, because it does give us the time to complete the standards work that we're doing, which we intend to get done later on in this year, first part of next year, which fits in the timing that you have here. And we're also trying to do it on an international basis. Because many of the manufacturers are international-based, we feel that that's important to expand that scope. But, for us, what's most important is one standard for the nation.

REP. PALLONE: Do you think you can -- I mean, I just want to restate the question. Do you think that, with respect to the technology, you will be able to actually accomplish what's set forth in the bill? I'm talking about the Buyer-Matheson bill, obviously.

MR. BONE: That's correct. That's correct -- yes, we do.

REP. PALLONE: Okay, thank you.

Mr. Buyer.


REP. PALLONE: I'm going to start dreaming track-and-trace here tonight with all the track-and-trace back and forth.

Thank you all. We certainly appreciate your testimony. And obviously, this is the second -- we're actually going to have another hearing on this bill, I think next week, dealing with the cosmetics and the medical devices.

But all your testimony has been very helpful.

MR. : (Off mike.)

REP. PALLONE: What's that?

Oh, yeah! The members -- well, let me mention that: The members can submit additional questions for the record to be answered by you. And basically, we get those questions submitted to the clerk within the next 10 days. So within 10 days or so, the clerk will notify your offices that you may have written questions. And we'd certainly ask you to respond to those.


REP. BUYER: Mr. Chairman, I'd like to thank you for your courtesy today, not only to do your draft bill, but to take into consideration Mr. Matheson and my bill.


REP. BUYER: I appreciate it.

REP. BUYER: You're welcome. It's very important and I'm glad that we had a good discussion about it.

So thank you again.

And without objection, the meeting of the subcommittee is adjourned. (Sounds gavel.)

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