U.S. FDA ingredient exceptions from banned Zhejiang Hisun plant draw scrutiny

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Exceptions on 15 ingredients from a plant run by Taizhou-based Zhejiang Hisun Pharmaceuticals that was banned from exports to the U.S. by the FDA have raised questions on the ability of inspectors to monitor the far-flung supply chains that are crucial to adequate supply.

Bloomberg reports that even with a well-documented history of inadequate quality controls in manufacturing and record keeping the company, which has a joint venture with Pfizer ($PFE) in China, Hisun-Pfizer Pharmaceuticals, continues to ship to the U.S. to ensure supplies of key cancer drugs.

Pfizer told Bloomberg that the import ban at the Hisun plant is not applicable to products covered by the joint venture.

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According to the news agency, the 15 ingredients used in finished drugs include key components of 9 cancer medicines.

The continued shipments highlight that more than 80% of drug ingredients are now produced abroad with most supplies coming from China and India--with manufacturers in both countries under a sustained  inspection regime that has led to dozens of plants banned on quality issues in the past two years.

In China alone, a long-running tussle has seen visas for inspectors routinely delayed.

The oncology-related ingredients include doxorubicin (Adriamycin/Rubex) and daunorubicin (Cerubidine) used to treat leukemia, breast and ovarian cancer, while others that can still be shipped include ingredients for antibiotics and irregular heartbeat medicine.

But as Bloomberg notes, bans can lead to shortages of crucial drugs, or the need to rely on more expensive options.

That has led critics to question the safety of the medicines.

“There is no transparency,” Erin Fox, director of the University of Utah’s Drug Information Service, told Bloomberg. “We just have to take FDA’s word that they think it’s OK.”

Hisun, in an email to Bloomberg, defended its efforts to get back into compliance at the plant.

However, the list of violations cited by the U.S FDA is long-running and affects the level of trust from doctors and patients to companies that outsource, Roy Guharoy, chief pharmacy officer at Ascension Health, the largest non-profit health system in the U.S. told Bloomberg.

“The quality control is so critical,” Guharoy told the news agency. “It’s a major concern for providers.”

- here's the story from Bloomberg

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