FDA Should Reinspect Chinese Plant That Makes Mifepristone, Editorial Says

Main Category: Abortion
Also Included In: Pharmacy / Pharmacist;  Regulatory Affairs / Drug Approvals;  Cancer / Oncology
Article Date: 05 Feb 2008 - 10:00 PST

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FDA should reinspect a plant operated by Shanghai Hualian -- a division of Shanghai Pharmaceutical Group -- where the medication abortion drug mifepristone, also known as RU-486, is manufactured to "ensure that the RU-486 production facility is adhering to rigorous quality control procedures," a New York Times editorial says. Mifepristone is made at a different factory than the one that recent news reports said produced contaminated leukemia drugs that have left 200 Chinese cancer patients paralyzed or harmed (New York Times, 2/3).

Mifepristone is made at a different factory than the one that produced the tainted cancer drugs. 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. FDA has declined to answer questions about Hualian, but in a statement the agency said the plant that manufactures mifepristone passed inspection in May 2007 (Daily Women's Health Policy Report, 1/31).

According to the Times, it "would be wise" for FDA to inspect the plant to ensure that it is following quality control procedures "in light of the company's current difficulties." The editorial concludes that the case "is one more frightening reminder of why Congress and the White House need to move quickly to strengthen the FDA and other regulatory agencies to ensure that they can adequately monitor foreign producers and intercept dangerous products before they can harm American consumers" (New York Times, 2/3).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

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