Panel I of a Hearing of the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee - The Food and Drug Administration's Foreign Drug Inspection Program
Interview
REP. STUPAK: This meeting will come to order.
Today we have a hearing titled "FDA's Foreign Drug Inspection Program: Weaknesses Place Americans at Risk." Each member will be recognized for an opening statement of five minutes. I will begin.
Today's hearing will once again explore the question of whether the Food and Drug Administration, FDA, is adequately regulating the overseas manufacture of pharmaceutical products. As this subcommittee has reported before, a significant and still growing quantity of pharmaceutical products used by Americans are now manufactured with ingredients obtained overseas from countries on almost every continent.
With the exact quantities and sources for these drugs difficult to determine, the general consensus is that at least 80 percent of all active pharmaceutical ingredients, APIs, used by U.S. manufacturers (or produced drugs ?) are imported. More importantly, much of this production occurs in regions that lack robust regulatory systems, such as China and India. China alone has more firms registered to export drugs to the U.S. than any other country, posing major challenges to the FDA.
As was noted by former FDA Commissioner David Kessler in a major news production, and I quote, "China is as close to an unregulated environment as you can get. In fact, it is a lot like the U.S. was in 1906," he says. "That's why we developed an FDA," end of quote.
The U.S. Food and Drug Administration is the agency responsible for overseeing the safety and effectiveness of all human drugs marketed in the U.S. As part of its effort to oversee the safety and quality of these products, FDA's policy is to physically inspect foreign establishments and ship drugs to the American market.
Last year this subcommittee asked the Government Accountability Office, GAO, to undertake a comprehensive audit of FDA's foreign drug regulatory system. The preliminary findings of that audit were presented at a hearing before this subcommittee on November 1st of last year.
GAO reported that a substantial lack of human and economic resources, weaknesses in data bases and IT systems used by the FDA to track inspections in drug imports and a lack of permanent operational support in foreign locations were major challenges facing the program.
GAO also found that many of the FDA data bases used to attract foreign firms that export to the United States contain substantial material inaccuracies that have yet to be reconciled by the agency.
More specifically, a lack of resources was determined to be a major factor undermining FDA's drug inspection program. For example, while current law requires FDA to inspect domestic firms once in every two years, which FDA is managing to do roughly every 2.7 years, GAO reported that FDA only has enough resources to inspect foreign firms about once every 13 years.
In China, one of the largest producers of active pharmaceutical ingredients for the U.S. market, FDA only inspects about 10 to 20 firms each year against an inventory of more than 700 firms. At this rate, the FDA can only inspect each Chinese firm about once every 30 to 40 years.
Worldwide, GAO concluded that on an annual basis, the agency only has enough resources to inspect about 7 percent of existing foreign plants, which amounts to inspecting one plant every 13 years. Given that these inspections are the most important tool the FDA has to ensure firms are meeting U.S. drug safety regulations, these rates are unacceptable.
FDA's IT systems for managing inspections and prioritizing risk was another major concern highlighted at the November 1st hearing. GAO testified that this system was antiquated, not designed for this purpose, and fraught with duplicate and inaccurate data. Such flaws made it difficult for the agency to assess risk and prioritize inspections.
Further, FDA could not determine how many foreign firms were subject to FDA inspections or where they were located. One data base suggested that there were 3,000 foreign firms registered with FDA to market drugs in the U.S., and yet another data base seemed to show that almost 7,000 firms actually shipped products to the United States.
How can there be any confidence that the FDA is adequately regulating foreign drug firms when the FDA has no idea who's making what, where they are physically located, and when they were last inspected? These problems, highlighted 10 years ago, still plague the agency today.
If the GAO and subcommittee findings were not enough to demonstrate that the FDA regulatory systems are broken, allow me to provide more evidence. In December of last year, a specially formed committee for the FDA presented a comprehensive two-year study entitled "FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology."
The Science Advisory Board report assessed the agency's ability to support a variety of existing and future regulatory operations. The special subcommittee that concluded this review was comprised of nearly three dozen external experts who represent industry, academia, and other government agencies. This subcommittee held a hearing on January 29th, 2008 to explore both the general concerns raised by the Science Review Board and their implications for food and drug import issues.
The report advisers, including Chairperson Dr. Cassell, who will testify again today, provided alarming testimony regarding FDA's deficiency in meeting its regulatory responsibilities. The panel was particularly troubled by the multitude of IT issues affecting the entire agency, including those related to foreign drug inspection programs.
With regard to the scarcity of resources for conducting foreign drug inspections at the agency, the report states, and I quote, "Although approximately 80 percent of the active pharmaceutical ingredients used in our prescription drugs are imported from abroad, and foreign imports of drugs and active pharmaceutical ingredients were valued at more than $42 billion in 2006, FDA conducted only 361 foreign drug and biological product establishments in 2006. Only 32 field inspections were made in India and 15 in China, the two largest sources of pharmaceutical exports to the United States. Millions of shipments of FDA-regulated products are now imported into the country each year from foreign facilities that have never been inspected by FDA, and, with current appropriations, never will be," end of quote.
The FDA commissioner was present at the January 29th hearing. During his testimony, the commissioner agreed to consult further with the subcommittee to explore ways to resolve the many problems identified in the science advisory report and address the multitude of concerns raised by GAO the subcommittee and others related to food and drug imports.
Almost immediately on the heels of the January hearing, the FDA was quickly overwhelmed by the very type of crisis these reports and audits predicted would occur -- contaminated heparin from China. As we are now familiar, in late 2007 and early 2008, FDA began noticing hundreds of reports of adverse reactions to heparin, including vomiting, breathing difficulties and low blood pressure, and as many as 81 deaths.
We would learn that tainted heparin was imported from China and that the Chinese facility, Changzhou SPL, which made the active ingredient, had never been inspected by the FDA because of multiple internal failures. Laboratory testing revealed that a foreign ingredient called oversulfated chondroitin sulfate had somehow been added into the heparin production chain. While an inspection into the origin of this contaminant continues, this tragic episode underscores the vulnerabilities in the current system used to regulate foreign drugs.
We have spent almost a year investigating the nature and extent of failures in FDA's foreign drug inspection program. After several hearings on the findings of the GAO, FDA's own science board, countless press articles and the subcommittee's own work, there are enough red flags to suggest to this chairman that it is time to act and fix this program.
GAO said it perfectly in last year's testimony, and I quote: "Until FDA responds to systemic weaknesses in the management of this important program, it cannot provide the needed assurance that the drug supply reaching our citizens is appropriately scrutinized and safe," end of quote.
To date, FDA has been unable to ensure the public these products are safe because they have not addressed the numerous systemic weaknesses many of us have identified. Because GAO and others will report today that many of the same problems we identified last year are still with us today, I can only conclude that American lives are still unnecessarily being placed at risk.
I look forward to hearing from the commissioner today. However, given the current nature of his agency's foreign drug inspection program, I think it is incumbent upon him to lay out a credible plan that demonstrates what steps the FDA has or will take to close these gaps and what resources and regulatory tools he needs to do the job.
Last year this nation's regulatory failure resulted in dead dogs and cats. This year it's tragically led to the deaths of people. If we don't make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us.
With that, I next recognize my ranking member of the committee, Mr. Shimkus from Illinois, for an opening statement.
BREAK IN TRANSCRIPT
REP. STUPAK: Thank you, Mr. Shimkus.
Mr. Commissioner, on page four of GAO's testimony it states, and I quote, "Regular inspections of manufacturing establishments are an essential component in ensuring drug safety." End of quote. Do you agree with that?
DR. VON ESCHENBACH: Yes, sir, I do.
REP. STUPAK: Okay.
Mr. Commissioner, you keep saying that the inspection would not have detected the heparin contamination. You don't know that. You don't know that because you don't know what you would have found if you would have inspected that lab or that plant because you didn't inspect them until after we had these deaths. In fact, Mr. Commissioner, the opposite can also be true, can it not, that you're lack of inspections -- like 30 years in China -- actually encourages manufacturers to do substitutes, like they did in this case here? If I'm not going to be inspected for 30 years, instead of using the pig intestines that you're supposed to use, why not use a sulfite chondroitin? No one's going to catch it, right? So why not use it? Same thing with melamine. We want to get a higher protein for this industrial food. Why not put melamine in there? You're not going to inspect us. It's going to take 30 years, so you'll never catch us. So one could easily argue that the lack of inspections actually encourage a less safe product in some of these plants. Is that not true?
DR. VON ESCHENBACH: Well, that's certainly one possibility, sir.
REP. STUPAK: Sure. So the only tentative answer we can give is, "Look, we didn't inspect. It was wrong. We're supposed to inspect. We inspect in this country every two to three years. We must inspect every two to three years for that deterrent effect that inspections cause, whether it's in the United States or in China or anywhere else in the world." Correct?
DR. VON ESCHENBACH: We need to inspect appropriately. And what I have been trying to express is the fact that we need --
REP. STUPAK: Okay. Before you go there -- before you go there --
DR. VON ESCHENBACH: -- not only to look at the number of inspections or the frequency, but the kind of inspections that we're doing.
REP. STUPAK: Okay. And I'm willing to go there with you, but you have to agree with me inspection is a deterrent.
DR. VON ESCHENBACH: I'm sorry, sir.
REP. STUPAK: Sure. You would agree with me that inspection is a deterrent.
DR. VON ESCHENBACH: It can be. Yes, sir.
REP. STUPAK: I mean, in the short time we've been here, toothpaste with the antifreeze DEG, cough syrup with the DEG, the melamine that mimics proteins, and now we got the heparin with chondroitin. So inspections actually acts as a deterrent.
Now, you want to talk about other ways of doing inspections. Our last hearing, I mentioned in the opening, was January 29th, and you were at that hearing. And I know you sat through it, and we appreciated the fact that you did. And you're talking about setting up -- in fact, Kyle, if you would put that pyramid up that the inspector had. He has his FDA on top, FDA presence, then you have these agreements. You have this pyramid here. It looks like at the very top you have the FDA, but on the bottom where the work is being done you're relying on third parties to do it. Is that sort of correct?
DR. VON ESCHENBACH: No. It's a pictorial graphic -- the FDA --
REP. STUPAK: Right here. See foreign capacity building, third- party certification program, foreign competent authority inspections.
DR. VON ESCHENBACH: That's intended to show that everything channels up to the FDA as the final authority. But actually you could turn it the other way around and say the FDA is the foundation for all of that.
REP. STUPAK: Right. And you were talking -- when Mr. Dingell was asking questions, other ways to do inspections, you were talking about third parties and having third-party certifications, right?
DR. VON ESCHENBACH: That's one other addition. Yes, sir. So it expands our effectiveness and our influence across a wider horizon.
REP. STUPAK: In one of your earlier slides, you show, besides drugs, we have medical devices, animal food, biologics all coming in this country from foreign countries, right?
DR. VON ESCHENBACH: Yes, sir.
REP. STUPAK: January 29th, when you were in the hearing, we had of GAO, and they talked about your third-party inspection programs. And especially on medical device manufacturing, your third-party inspection program has been around since 2004, and it's called the Accredited Persons Inspection Program, the pilot multipurpose audit program. And it shows that, over a four-year period, only five inspections had been accredited by these organizations, these third- party organizations. And the GAO concluded that the small number of inspections completed to date by accredited third-party organizations raises questions about the practicality and effectiveness of establishing similar programs that rely on third parties to quickly help FDA fulfill its responsibilities.
So you're saying this proposal you're talking about -- even in your testimony, so far at least, in medical devices, it's not going to work. It's not effective. There's too few of them. In four years, you had five inspections only from third-parties, so why is this going to be different?
DR. VON ESCHENBACH: Well, that's correct. And I've spoken to the people in CDRH about some of those barriers were for acceptance of that third-party. There are opportunities, I think, to improve upon that substantially.
The other thing is, of course, what we define by a third party. That could also, of course, be other foreign regulatory agencies which have their own jurisdiction. So, it's a -- it's a much broader scope.
REP. STUPAK: Sure, but even the FDA says, even in looking at your Beyond the Borders Program, the one you talk about in your testimony, we're lacking specific implementation steps. What are the associated timeframes with this "Beyond our Borders?" There's a lot of talk about this, but it will have little impact to reduce the interval between inspections. The FDA will have to -- you know, how do you plan on doing it?
DR. VON ESCHENBACH: Well --
REP. STUPAK: I mean, you talked about, first of all -- go ahead.
DR. VON ESCHENBACH: -- it's a multi-pronged approach. In addition to establishing this FDA Beyond our Borders Initiative. We're --
(Cross talk.)
REP. STUPAK: Okay, what's the main -- what's the main prong?
DR. VON ESCHENBACH: Pardon me.
REP. STUPAK: You said there was multi-prong approach. What's the main one?
DR. VON ESCHENBACH: Enhancing our current inspections --
REP. STUPAK: Okay, enhancing your current inspections --
DR. VON ESCHENBACH: -- this year, or --
REP. STUPAK: -- what date are you going to have your enhanced current inspections done by?
DR. VON ESCHENBACH: We did more foreign inspections this year than in the history of FDA. We can do even more next year targeting --
REP. STUPAK: Even with $13 million, and each one costs $45,000, you're going to do more?
DR. VON ESCHENBACH: We're targeting 500 foreign inspections next year, in addition to creating a foreign presence, which --
REP. STUPAK: Five hundred and forty-five thousand dollars? I wasn't a math major. That'd be about $200 million you're going to need, and you asked for $11 million. How is that going to jibe?
DR. VON ESCHENBACH: There's already an inherent -- it's up to 500. We're up to 350, approximately.
REP. STUPAK: See, I wasn't a math major -- so, that would be $20 million, not $200 million. So, either way, $20 million is about half of what you're -- of what you've asked for. So how do you get there?
DR. VON ESCHENBACH: Well, there's also the capability of leveraging what we already have in place.
REP. STUPAK: Okay. Leveraging with who? Who's going to do the inspections if you're not doing them? How are you leveraging? Who's doing them?
DR. VON ESCHENBACH: We have inspectors in the agency --
REP. STUPAK: Sure.
DR. VON ESCHENBACH: -- and we'll need to detail them to the foreign inspections that we're targeting.
REP. STUPAK: I see. So --
DR. VON ESCHENBACH: One of the things that's more efficient --
REP. STUPAK: Your IT system is broken. You don't -- how are you going to prioritize it? The GAO says you can't even tell us what's being produced and sent to the United States, therefore, it's hard to prioritize what it most significant to prioritize your inspections. So won't you start with your IT system, so you know who's out there? What are they sending? What is the --
DR. VON ESCHENBACH: Well, I --
REP. STUPAK: -- risk to the American people?
DR. VON ESCHENBACH: -- yes, sir. And we started that two years ago. That's in mid-course. We anticipate it'll --
REP. STUPAK: When will it be done -- you're at mid-course?
DR. VON ESCHENBACH: Pardon me?
REP. STUPAK: You're in mid-course, when will it be done? Two more years --
DR. VON ESCHENBACH: Two more years.
REP. STUPAK: So, two more years before we have an IT system that can tell us what's out there; what's -- who's producing what; and then to be able to prioritize our inspections. So, we've got to wait two more years before we can even prioritize --
DR. VON ESCHENBACH: Well, it's incremental. It's improving consistently and constantly, but it won't be at full maturation until two years. The data center, for example, at White Oak, at our consolidated facilities, is expected to open up in early '09 --
REP. STUPAK: Early '09, okay.
(Cross talk)
REP. STUPAK: Well, it's my understanding that you've proposed, but not yet implemented, a Foreign Vendor Registration Verification Program? When is that program going to start? I understand it's supposed to help improve the accuracy of the information in your databases.
And the way I understand the program, your Foreign Vendor Registration Verification Program, the FDA is going to contract with an external organization to physically conduct site verification on the registration data of the firm shipping drugs, and other FDA- regulated products to the United States.
When is that going to start? Have you began (sic) the Foreign Vendor Registration Verification Program? It sounds to me you're saying we can't do it internally, so let's get someone externally to do it. Have you begun that process?
DR. VON ESCHENBACH: Well, it's -- it's a matter of leveraging where those verifications are occurring for multiple purposes. We can benefit from that, because, as you pointed out, in the data system there is a lot of redundancy; there is, in fact, firms that registered and have -- are no longer shipping to United States, and that's what created that discrepancy in the data --
REP. STUPAK: Right, so you're going to have this Foreign Vendor Registration Verification Program, when is that going to start? Have you contracted with anyone to do this? That's what I'm asking.
DR. VON ESCHENBACH: That's -- that's in process. And I cannot tell you when that will be fully implemented, but it's in process --
REP. STUPAK: In '09?
DR. VON ESCHENBACH: I'd have to get back to about that, sir.
REP. STUPAK: Do you have any money in the budget to implement a Foreign Vendor Registration Verification Program?
DR. VON ESCHENBACH: If these are parts of the planning of the budget, (yes?).
REP. STUPAK: But, do you have -- in '09, is there a line in there for Foreign Vendor Registration Verification Program?
DR. VON ESCHENBACH: I cannot specifically speak to a line item for that.
REP. STUPAK: Okay. Shouldn't we really assign, in fact, some of the legislative -- legislative proposals has indicated a unique identification number to every foreign establishment that makes a drug, and that have all databases, including those used by FDA, Customs, track activities such as inspections, products alert? Shouldn't we have that?
DR. VON ESCHENBACH: Yes.
REP. STUPAK: You have that program ready to be implemented, where every establishment --
DR. VON ESCHENBACH: Well, that -- that's being done in collaboration with the other -- other agencies that you've talked --
REP. STUPAK: Okay. But, you can't give them a foreign inspection number until you know what firms are out there, right? You've got to establish the firms first before you can give them a foreign inspection number, right?
DR. VON ESCHENBACH: Correct.
REP. STUPAK: Okay. So, it sounds like you better find out what's out there first, correct?
DR. VON ESCHENBACH: Well, it's a combination of both. It's their registration, and our verification.
REP. STUPAK: Okay. My time has expired.
Mr. Burgess for questions.
BREAK IN TRANSCRIPT
REP. STUPAK: Thank you, Mr. Barton.
Mr. Commissioner, are you familiar with the program that was put in in the late 1990s with Europe, the neutral recognition agreement that they attempted to put in?
DR. VON ESCHENBACH: I'm aware of it, sir, but I'm not familiar with all the details -
REP. STUPAK: And what happened to that program?
DR. VON ESCHENBACH: I apologize. I cannot answer that for you today.
REP. STUPAK: Well, I've been on the Committee for a while, and it was under -- Mr. Barton actually was the chairman then. We had a hearing in 1998 on it, and basically, it didn't work. And this was with Europe, the European Union, where we were supposed to do mutual inspections. In fact, it says under this arrangement the E.U. member states will be taking the place of FDA when it comes to inspections for good manufacturing practices.
Now, if that program in the late 1990s didn't work with Europe, which is probably closer to us in culture and same standards and regulatory system, who on God's green earth is it ever going to work in China, where we have very little in common. If Europe doesn't work, how is it going to work in China?
DR. VON ESCHENBACH: Because I believe fundamentally the world's a lot different in 2008 than it was in 1998, and people's thinking is different.
I've just recently even met, a few days ago, with growers here in the -- (cross talk).
REP. STUPAK: Well, wouldn't we want to try to get back with Europe then, if it'd be easier to -- wouldn't it be easier to implement this agreement in Europe than in China? So why wouldn't we go back there, and then the inspectors we're using in Europe, we can use them in China. We can get to that 500 number that Mr. Barton talked about.
DR. VON ESCHENBACH: One of the places that's included in FDA beyond our borders is Europe. And working with our European counterparts is part -
REP. STUPAK: So do you have an agreement like that in Europe?
DR. VON ESCHENBACH: -- part of this effort. We haven't established the office in Europe, but it's part of the plan.
REP. STUPAK: Part of the plan which hasn't worked yet, and I don't see how it's going to work now.
Let me ask you this -- and I don't mean to be argumentative. Draft legislation, we issued your -- sent to your office a draft of our Committee, our latest copy of our food and drug inspection legislation. Have you seen this? We sent it to your office.
DR. VON ESCHENBACH: Yes, sir.
REP. STUPAK: Okay. Are you prepared to comment on it at all?
DR. VON ESCHENBACH: We're looking forward to working with you, (and ?) Chairman Dingell, and others on the Committee.
REP. STUPAK: Yeah, you say that all the time, but you never comment on our legislation. We're trying to help you out here, so --
DR. VON ESCHENBACH: Well, my staff has had multiple interactions with the staff of the Committee and we look forward to those continuing about the specific bill.
REP. STUPAK: We'd like to know where the FDA stands on the bill, okay? It's going to be moving quickly, so --
In fact, one of the parts in there, let me just ask you a quick question. Isn't it true that foreign drug manufacturing firms can register with the FDA even if the firm does not intend on shifting products to the United States?
DR. VON ESCHENBACH: Yes, sir.
REP. STUPAK: And in order to do that, you have to do an inspection and everything at the cost of the taxpayers, right? If you applied for -- you go and you do a pre-inspection, right?
DR. VON ESCHENBACH: That's correct, yes.
REP. STUPAK: Okay. And according to the GAO, some of these drug manufacturers register with the FDA as a marketing tool because the FDA registration might be seen as an endorsement of that plant by the FDA in some foreign markets. Are you aware of that?
DR. VON ESCHENBACH: I've heard that alluded to.
REP. STUPAK: Okay. Therefore, as in our legislation, won't the sizable registration fee ensure that foreign establishments who register with the FDA are serious about actually exporting drugs to the United States? In other words, a sizable registration fee, would it weed out those firms who wish just to register so they can market products elsewhere and not to the United States?
DR. VON ESCHENBACH: I can't comment whether that would be an adequate deterrent or not, sir.
REP. STUPAK: And they're gumming up your databases, aren't they, these firms that applied to get the U.S. certification, but they never ship? They're sitting in your database there, just gumming up that IT system that we're having so much trouble with, are they not?
DR. VON ESCHENBACH: Well, there may be important intelligence information about those firms that could be helpful to us. I don't know that it's gumming up the system. But they shouldn't be -- (cross talk).
REP. STUPAK: What important intelligence information would be in that database?
DR. VON ESCHENBACH: Pardon me?
REP. STUPAK: What important intelligence information would be beneficial by having them sitting in your database if they never ship drugs to the United States?
DR. VON ESCHENBACH: Well, maybe we'd learn something about them that we would never want them to ship drugs into the United States.
REP. STUPAK: Well, after you pre-approve them and they're registered, you would never know, because you don't go back and check them, because they're not shipping to the United States.
DR. VON ESCHENBACH: (Inaudible.) But by recognizing them, we might be able to cross-reference them with other databases that exist with our other counterparts around the world.
REP. STUPAK: How many man-hours and the amount of resources have we spent on this heparin investigation, do you know?
DR. VON ESCHENBACH: How many man-hours are spent on what, sir?
REP. STUPAK: On this heparin investigation thus far by the FDA. You've gone over and done an inspection over there. You have a couple reports on the 483. We got letters. How much time have you spent?
DR. VON ESCHENBACH: I can't give you an exact hourly figure.
REP. STUPAK: Give me a guesstimation. How many inspections could we have done if we would have -- what do you have, 90,000 (dollars ?), 100,000 (dollars ?) more?
DR. VON ESCHENBACH: I couldn't give you that estimate, sir.
REP. STUPAK: Okay.
DR. VON ESCHENBACH: Because I don't think they're exactly equivalent.
REP. STUPAK: Well, if you've gone over and done the inspection which was never done in this plant before, you already did one inspection there, right? On heparin? That's approximately 45,000 (dollars) to have a couple of people over there doing that, right?
DR. VON ESCHENBACH: Well, I thought the point of the question you asked me was what was the effort expenditure across the FDA.
REP. STUPAK: Correct.
DR. VON ESCHENBACH: The effort expenditure across the FDA involved a whole host of people in a variety places within the FDA that wouldn't necessarily translate into those people doing an inspection.
REP. STUPAK: I see. But -- (word inaudible) -- give you more money to do things.
Let me just change gears here for a minute. The FDA's primary goal here is to protect the public health. And let me ask you a question or two, and then I'll -- if anyone else wants to ask a question, they can, on the issue.
But on bisphenol A, BPA, okay? It's the chemical used in baby bottles that has terrible side effects. The National Toxicity Program at NIH has determined that BPA may cause neural and behavioral problems as well as effects in the prostate gland, mammary gland, and an early age for puberty in females. The Canadian government has declared BPA to be toxic.
The FDA continues to maintain that it's safe. While the FDA has undertaken a formal transparent reassessment of safety of BPA, to include notice in Federal Register, public comment, and expert advisory panels. When do you expect to have some decision on BPA?
DR. VON ESCHENBACH: Well, the (prime ?) learning of the new data, the new information (we have ?) convened an interagency task force to address that new data scientifically, and that's in process. And that will render our opportunity to make a decision. The Canadians are continuing their process of assessment with a commentary period.
So we'll be working with them, other counterparts, and our own internal scientific process, which is underway.
REP. STUPAK: When do you expect to have a decision?
DR. VON ESCHENBACH: I cannot tell you exactly when that decision will be made, because I don't know what the complexity of the analysis will involve. But it's underway.
REP. STUPAK: The Canadian government's already pulled BPA as being toxic, as they labeled it in their country. So why is it taking us so much longer to get at this -
DR. VON ESCHENBACH: I think it's, again, Mr. Stupak, it's going to be based on what the science dictates and what the science tells us. And until we have that analysis -- (cross talk).
REP. STUPAK: You're saying the Canadian government wasn't based on science?
DR. VON ESCHENBACH: What I'm saying is that FDA is going to assess the science and make its own independent decision, taking into account the information that's available from other sources, like Canada.
REP. STUPAK: Well, we'd like some decisions soon on BPA. You know, our Subcommittee's working on it.
DR. VON ESCHENBACH: We're acting upon this as we speak.
REP. STUPAK: I've heard so many of those promises, and they never come true. So I just want to make sure we have some date certain that you can give us when we could expect a decision on BPA.
Any questions from anyone?
Mr. Shimkus, Mr. Burgess.
BREAK IN TRANSCRIPT
REP. STUPAK: Thank you. You'll be happy to know our legislation does include in there registration fees so taxpayers aren't paying for it. And please look at it. We'll be moving that legislation quick.
Dr. von Eschenbach, thank you for your time. I hope you'll stay for the next panel. As I indicated earlier, they have 100 years of experience in these areas and, hopefully, we can all benefit from their expertise.
Thank you again for your time, sir.
DR. VON ESCHENBACH: Thank you, Mr. Chairman. Just let me close by expressing I know what you share and other members of the Committee share, and that is although we are talking about many important changes that have to occur at FDA, some of the things that we must always preserve is the caliber and the quality of the incredible people that make up that agency.
There are half of the agency involved in our field activities, and they are doing heroic work, as you just alluded to, with regard to our ability to immediately mitigate the problems associated with contaminated heparin.
And so I thank you for our opportunities to present to you a vision for the future, and I appreciate your recognition of the incredible effort that the people of FDA are making on behalf of the American people.
REP. STUPAK: I agree with you, and the best way we can honor their work is to give them the resources they need so they can fully do their job.
DR. VON ESCHENBACH: Thank you.
REP. STUPAK: Thank you.
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