US "Abortion Pill" Supplier Caught up in Chineses Tainted Drug Scandal, Leading to RU-486 Safety ConcernsJan 31, 2008 | Parker Waichman LLP
The Chinese manufacturer of the so-called "abortion pill" is accused of selling tainted cancer drugs in that country. Shanghai Hualian is the only supplier to the U.S. of the abortion pill, mifepristone—or RU-486. It is one of China’s largest state-owned pharmaceutical companies and exports to dozens of countries. News that the company that makes the entire US supply of RU-486 is at the center of a Chinese scandal over tainted drugs is truly disturbing.
The FDA said RU-486 exported to the U.S. is made at another Shanghai Hualian plant, and the “abortion pill” plant passed inspection in May. The agency said that “FDA is not aware of any evidence to suggest the issue that occurred at the leukemia drug facility is linked in any way with the facility that manufactures the mifepristone.” When told of Shanghai Hualian’s troubles, Dr. Sidney M. Wolfe, consumer advocate and FDA critic, said American regulators should be concerned because of rumors of cover-ups.
Zhou Qun, director of the Chinese FDA’s drug safety control unit in Shanghai, said her agency inspected the factory that produced RU-486 three times in recent months and found it in compliance. “It is natural to worry, but these two plants are in two different places and have different quality-assurance people,” Zhou said. Because of anti-abortion opposition, the FDA never publicly identified the abortion pill maker. Since its approval by the FDA in 2000, RU-486 has been distributed in the U.S. by Danco Laboratories. Last week, The New York Times asked the FDA if Shanghai Pharmaceutical Group exported drugs or pharmaceutical ingredients, other than the abortion pill, to the U.S. Despite many requests, the agency declined to answer.
According to the FDA, Shanghai Hualian’s shipments were stopped at the U.S. border at least twice in 2002: One, an unapproved antibiotic; the other, a diuretic with questionable labeling. Records indicate another unit of Shanghai Pharmaceutical filed papers declaring its intention to sell at least five active pharmaceutical ingredients to manufacturers for sale in the U.S.
Nearly 200 Chinese cancer patients were paralyzed or harmed by contaminated leukemia drugs. Chinese drug regulators accused the manufacturer—Shanghai Hualian—of a cover-up and closed the factory that produced them. In December, China’s Food and Drug Administration said that Shanghai police began a criminal investigation. Shanghai Hualian is a division of one of China’s largest pharmaceutical companies, the Shanghai Pharmaceutical Group, which owns dozens of factories.
Problems with cancer drugs surfaced last summer after leukemia patients received injections of methotrexate and experienced leg pain and/or paralysis. Authorities recalled two batches of the drug, issuing mild warnings. Another cancer drug made in the same factory caused adverse reactions and investigators suspected contamination. In September, health and drug officials announced they found two drugs were contaminated with vincristine sulfate, a third cancer drug, during production. After issuing a nationwide alert, the government announced a wider recall and Shanghai’s drug agency sealed manufacturing units at the plant. There are an estimated 53 victims in Beijing and at nearly 200 nationwide and it remains unclear how many were paralyzed, as authorities have not released an official figure. About half of those injected still cannot walk.
In China's harshest action, the country's former top drug regulator was executed for accepting millions of dollars in bribes to approve substandard medicines, including an antibiotic that killed at least 10 people.