RU-486 Manufacturer Disclosed

A leading Chinese pharmaceutical company that has made the abortion pill RU-486 for at least seven years will manufacture the drug for the U.S. market, officials said today.

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

The U.S. Food and Drug Administration approved the pill two weeks ago for U.S. consumption, but did not disclose the manufacturer’s identity and location because of safety and security concerns. The drug distributor in the United States, Danco Laboratories, has also refused to identify the company.

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

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

FDA Inspects Hua Lian

In July, FDA inspectors toured the Hua Lian plant, the Xin Lian factory on Shanghai’s 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 today’s edition that the China plant will manufacture the U.S. pill. Abortion opponents in the United States assailed the China connection, saying it undermined the FDA’s stated reasons for secrecy over RU-486’s production.

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

Of the estimated 10 million abortions performed annually, about half are done with abortion drugs, Gao said. Half of those, or about 2.5 million abortions, involve RU-486, he added.

For nearly 25 years, China has limited most urban families to having one child and rural families to two. Reports of forced abortion and sterilization are common, although the government insists its policy does not approve those measures. Abortion drugs have played an increasingly important role.

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