On April 29, 2008, the House Subcommittee on Oversight and Investigations initiated hearings: The Heparin Disaster: Chinese Counterfeits and American Failures
For more, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml
There were four majors areas of problems with production at Changzhou SPL highlighted in the testimony of Regina T. Brown, Consumer Safety Officer who did the inspection for the FDA. The first area was that inadequate procedures were being followed to determine what was in the Heparin API. Ms. Brown was questioned by U.S. Representative, Jan Schakowsky/: from Illinois, as follows:
Q of Rep. Schakowsky: Isn’t it true that SPL’s processing steps provided no assurance that they were capable of removing impurities:
Answer of Brown: YES.
Q: Now can you tell us why understanding the origin, quality and purity of these materials are essential for meeting Good Manufacturing Practices, particularly when you are making a biologic, such as Heparin?
A: In particular for Heparin, the Certificate of Analysis that came with the crude material into Changzhou SPL was the only source identifying it as crude heparin from a porcine source, from pigs.
Q: And why is that important that that was the only document?
A: Changzhou SPL had just begun PCR testing, which verifies the pig origin of the crude heparin in June or July of 07. So it was a relatively new test that they were doing. Prior to that, they hadn’t done it at all in China.
Q: Didn’t you find that the test methods performed by Changzhou SPL not been verified to assure suitability under actual conditions of use, is that what you are saying that it was unverified?
A: Yes, unverified. The tests that they ran were USP Compendial methods and we ask firms to verify that methods are suitable for use with their particular product.
Q: So what does it mean when the FDA says Changzhou SPL tests methods had not been verified to assure suitability under actual conditions of use, and why is this important?
A: One of the tests they ran was a protein test, that was a turbidity test, they put required solution in a in a big test tube, then added there substance to it and if turbidity showed up, the crude heparin did not have protein in it and if it did show up, it did have heparin in it and the crude heparin didn’t have heparin in it.. if it did show up, their was protein there. I think it was the opposite. If it got turbid there was protein in it.
A: “It is kind of a crude test, the first steps of the purification process, for heparin, involved getting rid of protein, so when they tried to do a process validation, and they use this turbidity test, in the process validation too, they never showed that it was repeatable and it may not have been suitable for use as an in product test or a even as a finished product test.”
The problem with this test is that it is not just a crude test. It is only an inclusion test. It tells SPL only that there is Heparin in the raw material, not that other impurities are not in the product.
Our next blog will discuss Regina Brown’s testimony with respect to non-sterile equipment that was used to make this drug.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
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