Saturday, March 08, 2008

Drug recall puts overseas inspections in spotlight

From the Globe and Mail:
A major U.S. recall of a blood-thinning drug linked to a Chinese factory last week is prompting new questions over the ability of government and industry to ensure the safety of drugs made with ingredients from China.

China has become one of the world's largest suppliers of pharmaceutical ingredients, but the country's questionable safety reputation, combined with reports of death and serious illness associated with Chinese products in the past year, has convinced some experts and industry members that North American governments need a more aggressive approach to overseas inspections and safety checks.

The issue has reached a boiling point in the United States in recent days after Baxter International Inc. expanded its nationwide recall of heparin, a blood thinner, amid reports it had been linked to 19 deaths and hundreds of illnesses. The affected products are not sold in Canada.

The U.S. Food and Drug Administration said this week that the problems may be the result of a counterfeit ingredient from China that was used in the drug. U.S. health officials had never inspected the Chinese factory owned by U.S.-based Scientific Protein Laboratories LLC where some of the raw heparin ingredients were processed. When U.S. inspectors finally visited the plant last month, they found evidence of and quality-control and hygiene problems. ...more

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