RU-486 Manufacturer Disclosed

ByABC News
October 12, 2000, 9:16 AM

B E I J I N G, Oct. 12 -- A leading Chinese pharmaceutical company that hasmade the abortion pill RU-486 for at least seven years willmanufacture the drug for the U.S. market, officials said today.

The China link adds to the controversy that has suffusedRU-486s hotly contested entry to the United States. Anti-abortioncampaigners who fought for eight years to keep the pill off theU.S. market have criticized Chinas widespread use of abortion,some of them forced, to limit family size.

The U.S. Food and Drug Administration approved the pill twoweeks ago for U.S. consumption, but did not disclose themanufacturers identity and location because of safety and securityconcerns. The drug distributor in the United States, DancoLaboratories, has also refused to identify the company.

The Hua Lian Pharmaceutical Co., based in the eastern city ofShanghai, has been contracted to make the raw compound in RU-486,mifepristone, for export to the United States, company executivesand Shanghai family planning officials said.

Hua Lian got help from the U.S.-based Rockefeller Foundation inwinning the production license for RU-486 under FDA specifications,said Gao Ersheng, a research director at the Shanghai FamilyPlanning Commission.

FDA Inspects Hua Lian

In July, FDA inspectors toured the Hua Lian plant, the Xin Lianfactory on Shanghais outskirts, said a plant manager, a Ms. Yang.Another family planning commission technical expert, Zhu Huibin,said Xin Lian was now upgrading its production line.

The Washington Post first reported in todays edition thatthe China plant will manufacture the U.S. pill. Abortion opponentsin the United States assailed the China connection, saying itundermined the FDAs stated reasons for secrecy over RU-486sproduction.

China began making mifepristone in 1993, Gao said, and Hua Lianis one of three Chinese companies producing the drug underdifferent brand names. Founded in 1939 and nationalized after thecommunist revolution in 1949, Hua Lian is a leading company in adomestic industry often marked by shoddy production.