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Last September, US regulators faced a dilemma: whether to allow importation of drug ingredients from a Chinese factory with a history of poor quality controls, or face shortages of treatments for American cancer patients.
Six months earlier, visiting Food and Drug Administration (FDA) inspectors had uncovered what the agency later called "broad data manipulation" at the factory, located in Taizhou, about 200 miles south of Shanghai. Information about the potency and purity of some product batches had been deleted, making it difficult to investigate a significant increase in customer complaints, the FDA said in a warning letter to the plant's owner, Zhejiang Hisun Pharmaceutical Co.
The agency issued an indefinite ban on the factory in September, a first for Hisun, one of China's leading exporters of pharmaceuticals products. Yet to avoid possible shortages of drugs, the FDA allowed the plant to continue exporting about 15 ingredients for use in finished drugs in the US, including nine key cancer medicine components. Hisun says that it takes quality seriously and has complied with requirements.
Daunting challenge
How the FDA came to this compromise underscores the daunting challenge the agency faces in making sure that drugs are not only safe for US patients, but also that they're available. More than 80 per cent of drug ingredients are now produced abroad, mainly in China and India. The FDA has stepped up inspections and added 13 Chinese plants this year to its banned list, but it's up to the drugmakers buying components exempted from its bans to control their quality. The agency doesn't test imported ingredients itself, and relies on pharma firms to ensure they're up to American standards.
Same standards
Drugs sold in the US are held to the same standards regardless of manufacturing location, the FDA said by e-mail. When products are exempted from its import bans because of shortage concerns, manufacturers are often asked to perform additional testing, hire independent auditors, or take other steps, the FDA said, declining to comment specifically on whether that was the case with Hisun. Drug manufacturers that import the components are responsible for testing, the agency said.
Companies aren't required to disclose to the public where they get their ingredients or where individual products are made, the agency said.
Hisun, in response to queries about its Taizhou plant, said through e-mail that it has always attached great importance to implementing good manufacturing practices, complied with regulatory requirements in China and abroad, and constantly improves its level of quality management.
While 15 products made at the plant have been barred from the US, about 15 others are still permitted because of the FDA's exemptions. Those include the chemotherapy ingredients doxorubicin and daunorubicin - go-to treatments for leukemia, breast cancer and ovarian cancer. Other exempt products are ingredients of antibiotics and a treatment for irregular heartbeats.
Poor marks
Before the March 2015 inspection that led to the ban, the FDA had conducted six human drug quality inspections at the Hisun factory in Taizhou between 2009 and 2013. Two led to so-called "voluntary action indicated" requests to fix problems, according to the agency's database, which doesn't specify the nature of the issues. While the database only goes back to 2008, Bloomberg was able to obtain some inspection reports from the early 1990s via the Freedom of Information Act.
The plant got poor marks during several inspections from 1992 to 1995, the documents show. Those inspections focused on daunorubicin, which Hisun had just started to sell to drugmakers in the U.S., and doxorubicin, which the company was awaiting FDA approval to sell.
The FDA said that until last year, Hisun had addressed any issue to the agency's satisfaction. It's not clear exactly how Hisun's inspections and citations compare to other companies', since the FDA doesn't make such records public.
