How US drug regulator overruled inspector and let tainted pills from China be used by US patients

Potential carcinogen may have been in generic version of blood pressure drug valsartan made by Zhejiang Huahai Pharmaceutical for four years

Chinese companies account for almost one in every 10 generic drugs cleared by the United States Federal Drug Administration

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The Zhejiang Huahai Pharmaceutical headquarters and production complex in Linhai, Zhejiang province, China. The generic drug exporter may have produced a heart treatment containing a potential carcinogen for four years before US regulators intervened. Photo: Bloomberg

Published: 9:31pm, 2 Feb 2019Updated: 9:30pm, 2 Feb 2019

US regulators sent a stark warning to American consumers last year: a Chinese-made heart drug taken by millions of people was contaminated with a possible cancer-causing chemical.

The Food and Drug Administration (FDA) oversaw a recall of the tainted pills. But even as it did so, the agency that helps safeguard a global supply chain of drugs was conducting fewer inspections of pharmaceutical plants in the country where the problem originated.

Treatments made by Chinese companies now account for almost one of every 10 generic drugs cleared by the FDA for sale. But agency inspections meant to ensure that approved drugs are meeting US standards fell almost 11 per cent, to 125, in China for the financial year that ended September 30, compared with the previous year, according to data obtained through public-records requests.

Using hundreds of pages of the US government documents, Bloomberg has spent the last year reporting on a supply chain that reaches around the world and ends inside American medicine cabinets. While overall inspections of that network are down, records show that those that do get done – from West Virginia to China and India – raise doubts about the data meant to prove drugs are safe and effective.

The Zhejiang Huahai Pharmaceutical Chuannan branch production base in Linhai, Zhejiang province, China. Photo: Bloomberg

Those doubts are sometimes overruled by FDA management. At the plant that set off the heart-drug recall in July 2018, an FDA inspector had determined in May 2017 that some of the drugs it was supplying to the American market might be substandard, according to an inspection report.

The FDA inspector’s 2017 visit had turned up a number of problems. The Chinese drug maker, Zhejiang Huahai Pharmaceutical, had omitted from official records quality-test results that showed unnamed drugs failed to meet US standards, and instead recorded passing grades, the FDA inspector wrote in his report. The inspector recommended that the agency send Zhejiang Huahai, one of China’s largest exporters of pharmaceuticals, a warning letter that likely would have meant it couldn’t gain approval to make any new generic drugs in that factory until it cleared up the list of problems.