[Pharm-policy] RE: [Ip-health] China to Make RU-486 for U.S.

[Horton, Linda R]

the Post article quoted from below did mention that FDA had inspected and
found acceptable whatever manufacturer it is who is making RU-486

> -----Original Message-----
> From:	James Love [SMTP:love@cptech.org]
> Sent:	Thursday, October 12, 2000 4:16 PM
> To:	IP-Health list; pharm-policy
> Subject:	[Ip-health] China to Make RU-486 for U.S.
> 
> 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
> 
> 
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