More on the Mifepristone's China Connection

Government and abortion industry representatives have largely been mum since the Wall Street Journal broke the news September 2 that a manufacturer in the Communist People's Republic of China could be producing the pill that will be used in the U.S. However, one enterprising grassroots pro-lifer, Jeannie Alexander, has found a Chinese pharmaceutical exporter on the Internet which lists the abortion drug on its product list.

The company's name is Sincer Pharmchem, of Xiamen, China. The web site ( www.sincerpharmchem.com ) says Sincer is "a team with more than 10 year [sic] experience in the field of

Pharmaceutical international marketing" which has been "involving [sic] in more than 1000 items including Bulk drugs, Drug intermediaries and fine chemicals for export out of China" [grammar and capitalization Sincer Pharmchem's].

The company says it has reliable connections with more than 500 customers and suppliers, including pharmaceutical manufacturers and trade houses, in mainland China, Hong Kong, India, Europe, Japan, and the U.S. Its "Export List I" lists "Mifepristone 98.5% MIN" as one of the bulk drugs it exports. Mifepristone is the generic name for RU486.

The China connection is significant for a number of reasons. First of all, it says something about the nature of the product and its promoters that Danco and the Population Council had to go to totalitarian, communist China, the land of forced abortions, to find a manufacturer willing to make the deadly drug.

Second, it raises questions about the purity of the product and the thoroughness of the FDA's inspections of the plant. China has been one of the world's leading sources of tainted drugs. It is worth asking what kind of inspection, if any, the FDA did of the Chinese manufacturer or manufacturers and whether or not the FDA has plans to monitor production and purity on an ongoing basis.

Third, it raises questions about the legal legitimacy of the FDA's approval decision. A representative of the French company now making RU486 claims the Chinese use a different synthesis process in making their pills, and says only that the pills are "very similar." If Chinese mifepristone is chemically different from the French formulation, then the FDA has no business approving the Chinese pill on the basis of French and American studies using the French pill.

The implications for those women and children sure to be injured or maimed by the pill are also troubling. Where will these injured women or their grieving families turn when tragedy strikes? Who will bear the moral responsibility and financial liability? Will the FDA back up these women's claims against a foreign drug maker?

Or has the FDA reached some sort of agreement with a Chinese manufacturer that will give that company an exemption from liability?

One of the most fundamental questions is whose interests the FDA is protecting in keeping this secret.

At a minimum, the government-endorsed secrecy surrounding the manufacturer seems a gross overreaction, given that the manufacturer is thousands of miles away in a country where political protests are prohibited and all tourists' movements are monitored. Yet here, as with the whole RU486 affair, the FDA put politics ahead of common sense.