The marketer of RU 486, Danco, which is located in New York, has contracted with a manufacturing plant in China to manufacture RU 486, known as mifepristone. The drug will be marketed under the brand name Mifeprex. Until recently, Danco has chosen to keep confidential the identity of the RU 486 manufacturer. It has been revealed that the Hua Lian Pharmaceutical Co., which produces RU 486 for Chinese women for population control purposes, will produce the drug for the United States.

The Rockefeller Foundation and Concept Foundation, which is located in Bangkok, have helped the Chinese pharmaceutical company to upgrade its equipment and to train its staff so that international standards can be met for the purpose of exporting the drug. 

China is a leading source of tainted drugs, and there are concerns that the FDA will not be able to control the quality of the drug. How could injured American women possibly hope sue a Chinese firm for any negligence in the manufacturing process? The arrangement worked out by Danco, the Population Council and the FDA is diabolical.

The House Commerce Committee staff has discovered that federal regulators have cited the Shanghai-based manufacturer, Hua Lian Pharmaceutical Co., for bringing mislabeled and impure drugs into the United States. FDA officials in Cincinnati confiscated a drug manufactured by this company (called betamethasone sodium phosphate) because of false or misleading labeling. In 1998 officials with the California Department of Health Services found that an herbal product produced by the company called tegafuri capsules were tainted with fluorouracil, a chemotherapy drug in some forms.

Rep. Thomas Bliley (R-VA), chairman of the House Commerce Committee, asked the FDA in a letter if the agency was aware that this company had been cited by federal regulators in the past and if the FDA took this matter into consideration during the approval process for RU 486. Bliley added that an FDA official, who inspected the pharmaceutical plant in Shanghai in 1999, complained in his report that the plant copied information from another application, instead of providing data from its own laboratory tests. [Los Angeles Times, October 20, 2000]. 

China is the land of forced abortions and sterilizations. It is fitting that the Population Council, which holds the rights to the drug, should arrange for it to be manufactured there. It was reported that Danco expects sales of 34.2 million by 2004. [Wall Street Journal, September 5, 2000].