Counterfeiting not an Unforeseeable Problem in Imported Heparin

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Posted on 30th May 2008 by gjohnson in Uncategorized

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The issue of counterfeiting imported drugs is neither new or unique to the Heparin disaster. In fact, this may be one of the biggest problems facing the pharmaceutical industry, worldwide. The FDA has devoted considerable resources to this issue for some time, including an entire portion of the FDA website, http://fda.gov to the issue of counterfeiting. See http://www.fda.gov/importeddrugs/

For example, at http://www.fda.gov/importeddrugs/chart071304.html the FDA reports its findings on three of the leading selling drugs that are being brought in from Canada: Ambien, Lipitor and Viagra. On all three of these drugs, the concentration level or purity (the same issues as with Heparin) are problems. For example, the above page says this about the safety of Viagra, a drug taken orally:
The sample tablets may be less clinically effective because of their reduced potency and poorer dissolution profile.
The sample tablets may also be less safe due to the elevated impurities.
This comment was made about a drug with only .7% impurities, unlike the up to 20% impurities in the contaminated heparin.

Clearly, both Baxter and SPL should have been on notice of the risk factors of contaminants and counterfeit in the raw material imported from China. With a drug intended for the human blood stream, that notice should have required the absolute utmost care.
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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