August, 2018

US FDA steps up recall of faulty Chinese heart drug

Original article: ABC News

The U.S. FDA is expanding a recall of drugs containing the China-manufactured active ingredient valsartan, which is used to treat high blood pressure. The FDA believes that valsartan contains N-nitrosodimethylamine (NDMA), a probable carcinogen. Valsartan is manufactured by Zhejiang Huahai Pharmaceuticals, based in China's Zhejiang Province.


Shoddy medicine, counterfeit or otherwise sub-standard, is a common problem in China. At the local level, China's news media regularly publishes stories about seizure of these products. In a July 26 report, Yicai Global said that authorities had seized over six tons of counterfeit medicine, including folic acid for pregnant women and anti-rheumatic capsules for the elderly. The contraband is valued at RMB 14 million.

In most cases, China's local media reports offer scant detail about the contents of the counterfeit or shoddy medicine. But experts say that adulteration with toxic substances could be more prevalent than we realize. 

"This carcinogen hidden in valsartan raises the question whether other products that are made in China have been made contrary to the global standard we came to accept," Rosemary Gibson, a senior adviser at The Hastings Center, told The Epoch Times in July. 

In a July 13 press release, the U.S. FDA said: "The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured." The FDA said it would continue investigating the NDMA levels in the recalled products, "assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company."

The U.S. FDA recall of valsartan comes on the heels of a vaccine scandal in China that has sickened dozens of children. Roughly 600,000 vaccines for diphtheria, pertussis, and tetanus have been declared defective. Chinese authorities say that the vaccines are substandard but not dangerous. 

Patrick Poon, a researcher at Amnesty International, told CNN in July that the public lacks confidence in Beijing's ability to maintain drug safety. "It seems the government hasn't been able to contain (the problem) and eliminate such incidents from happening again. So people are very much fed up," he said.

If China cannot maintain the integrity of its drug supply chain, and ensure drug safety, its ambitions to become a world leader in pharmaceuticals could be set back decades. U.S. President Donald Trump has already slapped hundreds of billions of dollars on Chinese imports and moved to restrict Chinese investment in U.S. technology assets. He doesn't need much of an excuse to target shoddy Chinese drug exports, even if U.S. pharma companies suffer collateral damage. 

In contrast, if Chinese regulators can establish better oversight of the drug supply chain, the U.S. offers a large market for generic drugs, which Chinese pharma companies have long produced for their domestic market. In 2017, Chinese drugmakers received FDA approval for 38 generic drugs, up from 22 the previous year. Sales in the U.S. not only boost profitability but also "prove their quality to Chinese patients who place greater trust in imported drugs," according to a March report in Frontline Genomics.