FDA allows banned China plant to ship chemo API that is in short supply

A Chinese drugmaker has caught a break from the FDA, which needs its help in the face of a shortage of a chemo drug often used to treat AIDS-related Kaposi's sarcoma.

The FDA revised its ban against Zhejiang Hisun Pharmaceutical last week to exempt another API manufactured at Zhejiang Hisun's plant in Taizhou City. The FDA is now allowing it to ship daunorubicin HCl, Regulatory Focus reports. The import alert said the exception was made because of a "critical drug shortage concern." The API is used in the injected med DaunoXome, which in addition to Kaposi's sarcoma is used to treat specific types of leukemia and non-Hodgkin lymphoma.

The FDA banned 15 drugs coming out of the Zhejiang Hisun plant in September but excluded the tuberculosis treatment capreomycin and 13 others at the suggestion of the FDA's Center for Drug Evaluation and Research. A warning letter posted last month savaged the facility "for systemic data manipulation across your facility, including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs."

An FDA spokesman told Regulatory Focus that "When FDA exempts certain drugs from an import alert due to shortage concerns, the agency also often requests the manufacturer to take certain measures to enhance quality oversight for products that are offered for entry into the United States." However, he couldn't say what, if anything, the Chinese company has agreed to do in this particular case to ensure quality.

This is not a precedent-setting move. In 2013, the agency was dealing with deep-seated issues at the Ben Venue Laboratories plant in Bedford, OH. The agency hammered the Boehringer Ingelheim contract manufacturing arm in 2011 after years of recalls and repeated GMP shortcomings. But because the sterile injectable drug facility at the time was the sole supplier for so many products, when it came time to lay out its mandates under a consent decree, the FDA allowed it to keep producing about 100 drugs considered "essential for patient care."

One of those was the ovarian cancer treatment Doxil made for Johnson & Johnson's ($JNJ) Janssen. When Boehringer finally gave up on the Ben Venue plant and closed it at the end of 2013, the FDA then allowed Janssen to set up a temporary manufacturing operation in a part of the closed plant to produce Doxil until a new contractor could be approved to manufacture the popular cancer fighter.

- find the Import Alert change here
- read the Regulatory Focus story