Hearing of the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee - The Heparin Disaster: Chinese Counterfeits and American Failures

Interview

Hearing of the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee - The Heparin Disaster: Chinese Counterfeits and American Failures

BREAK IN TRANSCRIPT

REP. CHARLIE MELANCON (D-LA): Thank you, Mr. Chairman.

First, let me thank the families for putting a face on this concern and this dilemma for the Congress and for the American public. And just because you're not getting all the questions doesn't mean that you haven't served a great purpose, and I thank you for that.

Mr. Nelson, is it possible -- and just to do some follow-up to what the chairman was asking earlier -- is it possible that Baxter appeared to perform an audit that found almost no major deviations from the CGMPs just five months prior to the FDA's inspection and closed out this audit about the same time your inspection of Changzhou SPL was concluding, and yet your audit found so many problems with this plant that it barred its product from entering the United States. What explains why your inspection found major problems while Baxter's audit found only a handful of minor deviations?

MR. NELSON: Well, just to be clear, Mr. Melancon, we didn't do the GMP investigation. What we're reporting on is the results of the FDA's --

REP. MELANCON: Yes, the FDA's. I'm sorry.

MR. NELSON: -- GMP investigations, and it is conceivably possible -- well, no, it isn't. I mean, if you look carefully at the observations, it really isn't possible for a plant to have fallen that far out of compliance in five months. The Baxter audit -- CGMP audit in 2007, some three years after they began receiving product from the plant, was performed in a day. I have no idea, but I suspect that they didn't have -- they had to rely entirely upon the company for translation of the records, and they obviously didn't look back very carefully at the supply chain. I mean, FDA at least not only inspected the plant but went back to the consolidators.

If we could put that slide up again showing the supply chain in China --

REP. MELANCON: Is that the -- yeah, there it is.

MR. NELSON: Here, you can see that Changzhou SPL used two consolidators. These consolidators are putting together the crude heparin that is actually manufactured in the workshops. It's combining them; it's basically preparing for them to go into the Changzhou SPL plant. And the FDA went to the two consolidators that supply Changzhou. Now, one of the consolidators is Changzhou SPL's partner, the 45 percent partner, and, in fact, the Changzhou SPL plant adjoins the consolidator's operation in China, the tech pool operation in China.

REP. MELANCON: Should the consolidators or should Changzhou SPL be the place for quality control, or is it one and the same?

MR. NELSON: It's got to be throughout the entire system, obviously.

REP. MELANCON: Yeah, from the beginning. In your mind, was Baxter's audit insufficient, or did the plant just fall out of compliance? And does this suggest that Baxter's audit missed major problems that were occurring at this facility?

MR. NELSON: I think --

REP. MELANCON: FDA's team was able, with just two people in about a week to find so many problems with this plant, and we're now barring products from this facility from entering the United States. I mean, why is it so easy when our guys went in?

MR. NELSON: Well, I think that there may have been a difference in the -- there was certainly a time difference.

REP. MELANCON: Yeah. The time difference was five months.

MR. NELSON: (Laughs.) Well, no, there was a time difference in the amount of time spent in the plant.

Baxter had one person go in there for one day. FDA, which -- for a plant of this complexity, I'm told, usually takes a couple of weeks if it's here in the United States -- sent two inspectors, one a chemist, to review to laboratory practices, and one investigator to do the rest of the GMP investigation. And they had five days at the facility. So if you want a measure of how hard people were looking, time alone would suggest a difference between what FDA was looking for and what Baxter was looking for, although they should have had the same concern about quality.

REP. MELANCON: In just the time of travel to get to China, they could have done what they did, it appears, in that one day over the telephone.

We've been told repeatedly by the drug industry that they police their own facilities and the supply chains. What kind of grade would you give Baxter in how it policed this facility, and if, in fact, FDA was able to find the kinds of CGMP deviations as noted in Ms. Brown's report merely five months after Baxter's inspection?

MR. NELSON: Well, at best, it was an incomplete, bordering on failure.

REP. MELANCON: Let's see if we can get -- did Baxter believe that this plant was suitable in how it produced heparin API for the U.S. market, whereas the government agency responsible for protecting the public health said this plant was unsuitable once it conducted its own investigation. So is that the case?

MR. NELSON: It would appear to be the case. We have both the FDA and the company here today, and I suggest that those questions could be put to them. But the appearance is clearly -- you're clearly correct.

REP. MELANCON: Thank you, Mr. Nelson. I yield back my time.

BREAK IN TRANSCRIPT

Source