The Hua Lian Pharmaceutical factory emerges from fields of sorghum and green onions an hour's drive south of downtown Shanghai. At quitting time, workers board company buses that take them back to the city. Others leave on bicycles, pedaling toward nearby villages along narrow lanes dotted with oxen.
Despite the tranquil appearance, the Hua Lian plant is a secret factory of sorts. Its name and location are shielded not by Chinese authorities, but by the U.S. Food and Drug Administration, which two weeks ago approved the sale of a product that workers here are preparing to churn out for the American market--the abortion drug RU-486.
Supporters of RU-486, which offers an alternative to surgical abortions, have for years sought a manufacturer to produce it for the U.S. market, ever since boycott threats by antiabortion activists led the drug's French developers to renounce U.S. production in 1992. For eight years, no pharmaceutical company would develop it for sale in the United States.
So when the FDA announced it had approved the sale of RU-486, it took the unprecedented step of refusing to disclose the name or location of the manufacturer, citing concerns about employee safety and security. The drug's U.S. distributor, Danco Laboratories, also refused to identify the firm.
But several Chinese officials and the head of a Bangkok-based foundation that has worked closely with the company confirmed today that Hua Lian Pharmaceutical Co. will produce the drug for the United States.
An FDA official in Washington declined to comment, citing the agency's position that it would not disclose the location of the manufacturing site. Danco said in a statement from its New York offices that the site was inspected by the FDA to make sure it met the agency's requirements but that it could not identify the plant or comment on its location because of a confidentiality agreement.
The fact that a state-owned company in China will be producing RU-486, or mifepristone, for U.S. consumers could become part of a debate over the drug in the United States. Told of the Chinese factory's role, U.S. antiabortion activists said they intend to question the safety and purity of Chinese pharmaceuticals and tie the drug to China's controversial one-child policy and human rights record.
Douglas Johnson, legislative director of the National Right to Life Committee, said his group found the news "very disturbing." He also criticized the FDA for its refusal to reveal that the manufacturer was in China, saying the agency's rationale was "highly implausible."
"They said they wanted to protect the company from violence or protests, but it's ludicrous to say that is an issue in China, where demonstrations aren't permitted," he added. "It's a public relations problem they want to avoid--they don't want the association with Chinese coercive abortion practices."
RU-486 has been a key ingredient in China's population control strategy for years. Of the estimated 10 million abortions performed annually in China, about half are carried out with RU-486, said Gao Ersheng, director of the Shanghai Institute of Planned Parenthood Research.
Hua Lian has been making RU-486 for at least nine years, one of three companies in China that manufacture the drug. Established in 1939 and nationalized after the 1949 Communist revolution, it is one of the largest pharmaceutical firms in China, according to its Web site.
With the help of the Rockefeller Foundation and the Bangkok-based Concept Foundation, the company has been working for three years to upgrade its equipment and retrain its staff to meet international standards in order to be permitted to export the drug.
The Concept Foundation was established by the World Health Organization and World Bank in 1989 to assist factories in developing countries to make medical products at low cost for Third World health agencies. The Rockefeller Foundation gave $2 million to the group in 1997 to help Hua Lian and China's state family planning agency upgrade the factory.
Joachim Oehler, who heads the Concept Foundation, said the goal was to enable Hua Lian to produce export-quality RU-486 to be used in China and elsewhere as an emergency contraceptive. He said the foundations knew that would also allow Hua Lian to export the drug to be used for inducing abortions, but that that was not their goal.
Oehler said FDA inspectors spent a week at the factory in July and agreed to allow Hua Lian to produce RU-486 in bulk amounts for export to the United States. The factory is not certified to export RU-486 in pill form, but Oehler said he expects it to meet those standards in three to five months.
In the meantime, he said, Hua Lian will send RU-486 in amounts of about 100 pounds to another factory that will make it into pills. He said he does not know the location of the other factory but assumes it is in the United States and does not know if other factories elsewhere might manufacture the drug for U.S. use.
"If you compare it with other manufacturers in China, they are among the tops in terms of their production standards," Oehler said of Hua Lian. "The factory is in very good shape. It would not have survived the FDA inspection otherwise."
The Hua Lian Pharmaceutical Co. denied multiple requests for interviews or a tour of the factory, as did its corporate parent, the Shanghai Pharmaceutical Group Corp. But Gao and three Hua Lian officials said the factory will be making RU-486 for export to the United States.
Oehler said it is unclear how much RU-486 the factory will produce annually, but he said it can manufacture at least half a ton a year, or enough to meet the entire world demand.
Neither abortion nor RU-486 is a subject of moral debate in China in the way it is in the United States.
During the first decades of Communist rule, government authorization was required to obtain an abortion, and it was often difficult to obtain, especially for unmarried women. As a result, women often sought abortions from illegal providers, who often prescribed various forms of folk medicine. In the 1970s, though, China began to adopt population control measures and the government changed its policy, allowing women to obtain abortions without government approval.
China began experimenting with RU-486 as early as 1983, participating in clinical trials with the World Health Organization. In 1988, along with France, it became one of the first countries to approve the drug. By the mid-1990s, the drug had become popular for women seeking an alternative to surgical abortion.
Gao, the director of the research institute, attributed the popularity of the drug in part to the fact that most surgical abortions in China are performed without anesthesia and are thus extremely painful. In addition, many Chinese women choose RU-486 because they fear that complications during surgical abortions might harm their ability to have children later, other experts said.
"RU-486 has given women more choices, and it's been beneficial to women's health. It has also helped us limit the growth of the population," Gao said.
He also said he was not surprised by the debate in the United States. "My feeling is that isn't should be opposed. But if you oppose abortion, I understand. But you shouldn't oppose it just because it's made in China. That shouldn't matter at all."
Staff writer Marc Kaufman in Washington contributed to this report.