The state-owned Chinese pharmaceutical manufacturers Shanghai Hualian, the only suppliers of the abortion pill RU-486 to the United States, have paralyzed or injured over 200 cancer patients in China with tainted leukemia drugs. According to the New York Times, the factory that produced the contaminated drugs has been closed, and the factory that makes RU-486 (aka mifepristone) is an hour away. This is the first time the F.D.A. is publicly announcing the American supplier of the abortion pill; the Times reports that the F.D.A. kept the manufacturers a secret because of security concerns stemming from “sometimes violent opposition to abortion.”
Although a FDA spokesman said “[We are] 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”, Shanghai Hualian doesn’t exactly have the greatest recrod: In 2002, shipments from the company were stopped at the U.S. border because they were unapproved or mislabeled, and pharmaceutical behemoth Pfizer won’t import from Hualian at all because of its concerns with quality issues.
What is currently unclear and mildly troubling is why all the mifepristone in the United States is manufactured by a single company at a single factory in a country with a checkered history of drug regulation. Instances of bribery in the Chinese drug industry are so extreme that the top drug safety official was executed last year because he had accepted money to approve drugs. In addition, the same inspector responsible for the factory producing the tainted cancer drug, Gu Yaoming, met with F.D.A. brass in conjunction with the RU-486 factory inspection, all of which makes Tuesday’s news that the FDA is the equivalent of 13 years behind in inspecting foreign drug manufacturers all the more inspiring!
Finally we have to wonder whether this news will affect the number of non-surgical abortions in the United States. Since RU-486 was introduced in 2000, the percentage of abortions performed through the pill has risen steadily, and at this point 14% of all abortions are “miffy” induced. Does this new information make you wary of taking RU?
Tainted Drugs Linked to Maker of Abortion Pill [New York Times]
Related: For F.D.A., A Major Backlog Overseas [NY Times]
Earlier: Experts Don’t Understand Why Fewer American Women Are Getting Abortions