FDA turns to banned factory to prevent cancer drug shortages

What's worse: importing drug ingredients from a Chinese factory with known quality control issues or experiencing a shortage in the U.S. of crucial cancer drugs?

In 2015, the Food and Drug Administration issued an indefinite ban on a drug plant owned by Zhejiang Hisun Pharmaceutical Co., one of China's largest exporters of pharmaceutical products, according to Bloomberg.

To prevent drug shortages, the FDA allowed the factory to continue exporting approximately 15 drug ingredients to the U.S., nine of which are key components for cancer medications.

The FDA told Bloomberg that while U.S. manufacturers are not required to publicly disclose where they get their ingredients from, they are responsible for testing the purity, strength and quality of imported products exempted from the ban.

“Not all U.S. companies are doing that,” said Robert Fish, former head of the FDA's domestic and internal investigations. “It costs money.”

The FDA relies on an honor system to ensure the quality of drug imports and declined to comment on whether companies receiving exempted drug ingredients from the Chinese plant are performing the testing. Instead of doing the testing themselves, the agency also allows drugmakers to rely on tests done by component suppliers to ensure ingredient efficacy.

More articles on the drug market:

FDA approves Crestor's generic rivals, much to Astrazeneca's dismay
Push to lift Medicare ban on obesity drugs garners attention at RNC
India's growing role in the US generic drug market: 5 things to know

 

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