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China Counterfeit Diabetes Tests Tracked by J&J (China)

This article was originally published in PharmAsia News

Executive Summary

Johnson & Johnson has tracked to China counterfeit versions of an at-home diabetes test used by 10 million Americans to take sensitive measurements of blood-sugar levels. Potentially dangerous copies of the OneTouch Test Strip sold by Johnson & Johnson's LifeScan unit surfaced in American and Canadian pharmacies last year. Johnson & Johnson learned of the counterfeit tests after 15 patients complained of faulty results last September. Tipped off by Johnson & Johnson, the U.S. Food and Drug Administration issued a nationwide consumer alert in October without disclosing the link to China. While no injuries were reported, inaccurate test readings may lead a diabetic to inject the wrong amount of insulin, causing harm or death, the agency said. "Growth in counterfeit medicines and devices is probably the biggest health threat besides infectious disease,'' says Peter Pitts, director of the Center for Medicines in the Public Interest in New York and formerly an FDA official investigating knockoff drugs. Court filings disclose that China is the source of about one million phony test strips that have turned up in at least 35 states and in several countries. "The source was from China, through Canada, to the United States,'' says Steven Gutman, director of the Office of In Vitro Diagnostic Devices and Evaluation at the FDA. "As far as we can tell, the counterfeiter has been put out of business in the U.S." The case is Johnson & Johnson v. Champion Sales Inc, 06-cv- 05451, U.S. District Court for the Eastern District of New York (Brooklyn). (Click here for more - May Require Free Registration
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