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How Carcinogen-Tainted Generic Drug Valsartan Got Past the FDA

Sept. 13, 2019, 11:01 AM

The regulatory system for generic drugs is built on trust in manufacturers. While the Food and Drug Administration has a rigorous approval process for new medicines, generic drugmakers have to show only that patients will absorb them at the same rate as the name-brand medications they mimic. The complex global system for producing generics usually functions beyond view—until there’s trouble.

Supplier Woes: One case in point involves the blood-pressure medicine valsartan, which has been subject to recalls after being determined to be tainted with a probable carcinogen. An inspection of the first Chinese manufacturer found to have contaminated valsartan uncovered ...

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