We’re opening up a new era, not just new offices...a permanent F.D.A. presence in China.
So claims Mike Leavitt, Secretary of Health and Human Services for the Bush administration. Well, at least there will be a physical presence -- but whether or not this office will be able to inspect any of the factories it wishes remains to be seen. It is unlikely the Chinese government will give the American government the access it wishes. Let us not forget similar programs which have come up against extraordinary stonewalling, e.g. Validated End-User (VEU) inspections under the BIS, requiring on-site inspections in China for certain technology items requiring a license prior to shipment.
The American public barely knows of that program and its frustrations, failures and very limited successes. Imagine the potential publicity of American inspections in Chinese factories where access is unfettered! No, indeed, there will be epic battles between Chinese and American regulators over destination factories. American regulators are sure to be on the short end of the stick. One hopes that the stories of these bureaucratic tangles will find their way to the press -- I will be pleased to post a report of anyone so involved, especially any of the eight inspectors who are supposed to be manning the office. You may remain confidential...
