The U.S. Food and Drug Administration (FDA) issued a warning letter to the Chinese drug manufacturer of the active ingredient in valsartan, a drug used for blood pressure and heart problems. The letter is another step in the FDA-led investigation of the drugmaker, that began in July.
The FDA’s letter was addressed to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP) and “outlines several manufacturing violations at ZHP’s Chuannan facility, including impurity control, change control, and cross-contamination from one manufacturing process line to another,” the agency said. The root cause of cancer-causing impurities is being investigated by the FDA, it said Dec. 11.
“We’re continuing to investigate and take action to protect patient health and safety from products in this angiotensin II receptor blocker (ARB) class that have been found to have dangerous impurities. As part of that investigation, we’ve uncovered serious manufacturing violations at ZHP, which is one of the manufacturing facilities that has been linked to these products. The issues cited in the warning letter are associated with the nitrosamine impurities found in these drugs, and these violations reveal a disturbing lack of oversight at this [active pharmaceutical ingredient] manufacturer that puts patients at risk,” FDA Commissioner Scott Gottlieb said in a statement.
It added that Zhejiang Huahai Pharmaceutical was placed “on import alert” earlier this year due to impurities in valsartan, the FDA said.
In the letter, posted online, “Until you correct all deviations completely and we confirm your compliance … FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.” And, “failure to correct these deviations may also result in FDA continuing to refuse admission of articles manufactured at Zhejiang Huahai Pharmaceutical Co.,” the FDA warned.
The FDA said the Chinese firm has 15 business days to respond to the letter.
The massive valsartan recall was first initiated in July after N-Nitrosodimethylamine (NDMA) was discovered in the drug. NDMA is a known carcinogen. Other investigations triggered recalls of other valsartan-containing drugs along with irbesartan- and losartan-containing products, the FDA said.
In early December, drugmaker Mylan Pharmaceuticals recalled more valsartan-containing medication. A comprehensive list of all recalled drugs can be accessed here on the FDA’s website (PDF).
“The FDA continues to test all ARBs for the presence of impurities and has publicly posted two methods for manufacturers and regulatory agencies around the world to test their ARBs for the unexpected NDMA and NDEA impurities,” said the FDA.
The FDA also said it was halting imports after it found major manufacturing process issues during its inspection of ZHP’s plant. The agency said the freeze on the imports would remain in place until the Chinese manufacturer determines how the impurities were introduced and improve its quality control systems, Reuters reported two months ago.
During the first wave of recalls, one expert said China’s drug manufactuers are out of control and don’t pay attention to quality.
“There is a lack of trust in medicines made in China now,” Rosemary Gibson, a senior adviser at The Hastings Center and an author of several books on health care issues, told The Epoch Times about the recall.
“The public wants their medicine to be safe. 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,” Gibson told Epoch Times. “We need to view medicine as a strategic asset, just like how we view oil and energy supply. A strategic asset is something that will make our country fall apart if we don’t have it.”
ZHP sold some $50 million worth of valsartan in 2017 alone, according to the report.