[Pharm-policy] China to Make RU-486 for U.S.

[James Love]

At the Sept 15 TACD meeting in Brussels, the US FDA said developing
country manufacturers of generic drugs could not be trusted.  But
apparently RU-486 for the US market will be made in China, by Hau Lian
Pharmaceutical Company.  Jamie


http://www.washingtonpost.com/wp-dyn/articles/A53938-2000Oct11.html

China to Make RU-486 for U.S.

By Philip P. Pan      Washington Post Foreign Service
 Thursday, October   12, 2000; Page A01 


SHANGHAI, Oct. 11 -- 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.

  [snip]   


-- 
James Love  mailto:love@cptech.org http://www.cptech.org
Consumer Project on Technology, P.O. Box 19367, Washington, DC 20036
voice 1.202.387.8030  fax  1.202.234.5176