Chinese Supplier Of Mifepristone To U.S. Linked To Tainted Drug Case

Main Category: Abortion
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 01 Feb 2008 - 5:00 PDT

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Shanghai Hualian -- a division of Shanghai Pharmaceutical Group and the sole U.S. supplier of the medication abortion drug mifepristone, also known as RU-486 and sold under the brand name Mifeprex by Danco Laboratories in the U.S. -- has been linked to the manufacture of contaminated leukemia drugs that have left 200 Chinese cancer patients paralyzed or harmed, the New York Times reports. According to the Times, mifepristone is made at a different factory than the one that produced the tainted cancer drugs.

According to the Times, Chinese drug regulators have accused Hualian of a cover-up and have closed the factory that produced the leukemia drugs. In September 2007, Chinese health and drug officials announced that they had found that two cancer drugs -- one of which was methotrexate used for leukemia patients -- were contaminated with vincristine sulfate, a third cancer drug, during production. China's State Food and Drug Administration said that the Shanghai police had begun a criminal investigation and that two company officials had been detained.

The U.S. FDA declined to answer questions about Hualian and did not cite a reason. The agency has never publicly identified the maker of the mifepristone for the U.S. market. However, the agency in a statement said the plant that manufactures mifepristone passed inspection in May 2007. The statement added, "FDA is not aware of any evidence to suggest the issue that occurred at the leukemia drug facility is linked in any way with the facility that manufactures the mifepristone."

Zhou Qun, director of the Chinese FDA's drug safety control unit, said the agency has inspected the factory that produces mifepristone three times in recent months and found it in compliance. "It is natural to worry," Zhou said, adding that "these two plants are in two different places and have different quality-assurance people." According to the Times, a notice at Hualian's closed plant dated Sept. 8, 2007, identified a company official, Gu Yaoming, as the "person responsible" for the plant. Records show that Gu met with U.S. FDA inspectors last May as part of a routine inspection of the plant that produces mifepristone, the Times reports.

Sidney Wolfe, a consumer advocate, said U.S. regulators should be concerned because of accusations that serious health risks have been covered up in China. He added, "Every one of these plants should be immediately inspected." Yan Jiangying, a spokesperson for the Chinese FDA, said that Hualian had been stripped of its license to produce anti-cancer drugs but that the action did not affect its production of mifepristone. Neither Hualian nor its parent company commented on the tainted medicine. Representatives from Danco also did not return calls for comment, the Times reports (Hooker/Bogdanich, New York Times, 1/31).

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