The target is a Chinese company that markets the Ru 486 pill in America
NEW YORK . The Chinese pharmaceutical company that makes the Ru 486 abortion pill for the United States has sold contaminated or spoiled medicines to China, causing 200 people to become paralyzed. The Chinese government-owned company, Shanghai Hualian, is the subject of an investigation by China's Medicines Safety Agency after the anti-leukemia treatment it develops and markets was found to be highly dangerous to human health, according to a story published on the front page of the "New York Times" yesterday. Shanghai Hualian is the manufacturer used by Danco Laboratories, the only authorized US distributor of Ru 486, or mifepristone. The Food and Drug Administration, the US agency that authorizes the marketing of drugs, has never publicly admitted that the abortion pill available in the US comes from a Chinese company. The scientific experimentation that led to the approval of RU 486 by the FDA in 2000 was in fact conducted in the USA using the abortion pill produced in France. But documents disclosed in the past by the "Washington Post" reveal that the FDA is aware that Danco Laboratories buys the drug from Shanghai Hualian. In 2002, however, the FDA itself returned two cargoes of medicines from the Chinese company to the sender, an antibiotic and a diuretic, because they did not meet American safety standards. In response to yesterday's "Times" article, the FDA made it known in a statement that it "is not aware that the problems that have emerged at the plant that produces the anti-leukemia drug are in any way connected to the production of mifepristone." But some American experts yesterday highlighted that the FDA has a duty to investigate any doubts that emerge about the quality of drugs imported into the US and that in case of uncertainty it must withdraw the drug from the market. One of the first steps that the FDA should take, according to Sidney Wolfe, a patient rights advocate, is to start sweeping inspections of all Shanghai Hualian plants. Danco Laboratories, repeatedly contacted, refused to comment on the news. (E.Mol.) Avvenire of 02/01/2008 p. 14
