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

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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

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REP. HILDA SOLIS (D-CA): Thank you, Mr. Chairman.

I wanted to ask you, Ms. Woodcock, if you could explain for us -- you gave an amount at a previous hearing of what you might need for foreign inspections, we talked about that already -- but could you give me a more descriptive amount that would be needed so that you could upgrade your systems, which would include technology, and go a little bit further in detail? And if you could do that quickly (laughs)?

MS. WOODCOCK: Yes. I think I can answer factual questions on that. The FDA Science Board Report -- which a subcommittee report, which I don't know whether all of you have seen, went over the state of FDA's information technology and our systems. And they could best be described as in a crisis. They are obsolete.

So, we need -- FDA will need to invest at least $20 million this year, and for many upcoming years, to put our basic infrastructure -- IT infrastructure in place. There's no use us building new systems for imports if we can't run them on our infrastructure. So that will cost probably about a $20 million investment each year for a number of years.

And then, I think, for imports, what we need to do is do electronic drug registration and listing -- okay, so it is totally electronic, and so forth. That would be a very modest amount of money, perhaps $10 million, to build a quick-fix type of system. We have done a business plan for this. I was requested by Mrs. Emerson to develop a business plan, and we have developed that. So, that would be a modest amount of money.

Then fixing the interface -- the processing at the border, the interface with Customs would probably require, again, tens of millions of dollars for a number of years to get that repaired. But none of those, I think, are extreme expenditures that would be required.

REP. SOLIS: So, you -- could you provide our committee with more details, figures about how -- I mean, this is probably, you know, not the time for you to give us all that, but if you could come back and give us, you know, something in writing as an approximation. I mean, when you're saying years -- five years, 10 years, or what, you know -- ?

MS. WOODCOCK: Three years. I don't think we can wait.

REP. SOLIS: That's what we need to know.

MS. WOODCOCK: Be happy to do that.

REP. SOLIS: And one concern I have -- I mean, given that we got this information -- I mean, our consumers that were affected by the importation of heparin from China, and the detection was so late and, unfortunately, we had numerous deaths as a result of that -- I'm very concerned about what we're doing to reach communities, particularly communities of color, that speak different languages, that may not understand information that's provided by your office.

I know that you post -- you have a website so people who have internet access can get that information. But, for the most part, we have a lot of people, including those in my community, who don't have access to the internet. And they may not even be able to read at the 12th grade level the information that you post. And you've been told that you need to lower that level of literacy to the 4th and even -- well, the 8th and even 4th grade level.

So, I want you to touch on that, and I want to know what you're doing to help provide more information to people of different -- that speak different languages. And I'm talking right now, especially the Hispanic population, which is the largest ethnic minority and has a tendency to -- their first language to speak is Spanish in some cases.

MS. WOODCOCK: Certainly. And I can't agree with you more. This is on the other end of our efforts -- which is not the, sort of, prevention, but if something has happened, how do we respond, and how do we actually reach out and make sure people are kept safe by using the knowledge, getting the knowledge that we actually have and being able to utilize it.

We are working, say, on our early alert system, evaluating translating that into different languages. We write patient level information that we put on the internet. But, as part of our Safety First and Safe Use Initiative, as we move into our Safe Use Initiative in the center for drugs, it's going to involve partnering with health care organizations and professional and patient and advocacy information, to make sure that that hand-off works -- so that what we know, they know; and that they can be -- help provide that information to their group, whatever it might be.

REP. SOLIS: Would that be an additional cost then, that you would -- I mean, you're going to need funding, I would image -- some resource to be able to do that. Because, again, many in our community don't have access, even if you're in rural America, you may not have internet access. So, you know, what kind of plan -- is that in your business plan, I would ask?

MS. WOODCOCK: Well, our business plan is on the other end, which is finding these events and picking that up. This is on our other initiative that has to do with patient safety --

REP. SOLIS: Right.

MS. WOODCOCK: -- and drug safety, adverse events, and so forth. Certainly we could do more if we had more resources, but we do plan to do this. We received additional resources for patient drug safety under the Amendments Act, and this is part of our implementation of that.

REP. SOLIS: What is that budget, by the way?

MS. WOODCOCK: Well, we received $25 million additional, but to do a very large number of things (laughs).

REP. SOLIS: Okay, can you get back to me with that --

MS. WOODCOCK: I'd be happy to do that.

(Cross talk.)

REP. SOLIS: -- because I think it's really important to be able to have a rapid response.

MS. WOODCOCK: I agree with you.

REP. SOLIS: And you mentioned, when we talked about inspections, and the lack of inspections abroad, and could you tell me if there's any data on how many inspections are conducted for facilities that manufacture brand-name drugs, versus generics?

MS. WOODCOCK: Yes, I have that information and can get it back to you. We have it cut that way. Yes.

REP. SOLIS: Can you talk -- I mean, just briefly give me an --

MS. WOODCOCK: (Laughs.)

REP. SOLIS: -- idea of what that is?

MS. WOODCOCK: I can't right now. There's a higher proportion of the generics have their API source in foreign countries. And so we -- and also the pre-approval inspections are supported by user fees for the new drugs. So, naturally, we're able to get to more the new-drug facilities that are producing those drugs, than to the generic drug facilities, because we don't have support for -- as much support for that activity, and a higher number of them are in foreign countries. But, I -- it's --

REP. SOLIS: Doesn't that raise -- I mean, for me, that raises a red flag.

MS. WOODCOCK: Absolutely.

REP. SOLIS: Okay. I'll yield back the balance of my time, Mr. Chairman.

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