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

[Jim Warren]

>>   ... if the Chinese can make RU-486 for American women, maybe
>>  the Thai, Indian, Brazilian, Korean or Chinese can make other medicines
>>  of  acceptable quality.
...
>>  --------------------------
>>  James Love, Consumer Project on Technology, http://www.cptech.org
>>  love@cptech.org, v. 1.202.387.8030, f 1.202.234.5176


At 7:11 PM -0400 10/12/00, "Horton, Linda R" <LHORTON@OC.FDA.GOV> wrote:
>There needs to be assurance of adherence to GMPs needed to assure that drugs
>have acceptable safety, quality, potency, etc., through rigorous
>inspections.

Given that the FDA and US Customs presumably already control the 
import of massive quantities of approved drugs from other foreign 
manufacturers, even including non-caucasian/asian manufacturers, why 
would you think that it would be any different with this single, 
politicized drug?

Why would someone from the FDA even need to state such an obvious requirement?

--jim, Jim Warren; jwarren@well.com
Contributing Editor & technology public-policy columnist, MicroTimes Magazine
Editorial contributor, Government Technology Magazine
Also GovAccess list-owner/editor