Recruiting in China

The Food and Drug Administration announced on 14 March that it has received approval from the State Department to establish eight full-time permanent positions at U.S. diplomatic posts in China, pending authorisation from the Chinese government. The FDA plans to hire and place these employees at the U.S. embassy in Beijing and the U.S. consulates general in Shanghai and Guangzhou over the next 18 months. An agency official characterised the establishment of a permanent FDA presence in China as a "significant step toward ensuring access to safe food, drugs, and medical devices in the global market." Among other things, these offices will allow greater access for inspections and greater interactions with manufacturers to help assure that products shipped to the U.S. meet the applicable safety and manufacturing quality standards.
The safety of imported food and drug products, especially from the mainland, continues to be a significant concern among U.S. lawmakers. The most recent incident that has caught their attention is the importation from a Chinese drug plant that went uninspected by the FDA of a contaminated ingredient that was used in the production of a blood-thinning drug in the U.S.

In response, Senator Charles Grassley, the senior Republican on the Senate Finance Committee, wrote to the FDA recently to inquire about the possibility of imposing registration fees on foreign manufacturers of drugs and active pharmaceutical ingredients. Grassley pointed out that many such companies register with the FDA "as a means to bolster their own standing and with no intention of exporting products to the United States market" and that this slows the FDA inspection system. At the same time, he said, other factories send these products to the U.S. without registering at all. Imposing registration fees could not only increase the funding available to conduct inspections but could also reduce the number of companies that register and thus the number of inspections that must be done. Grassley noted that foreign medical device makers are already subject to such fees, which are currently set at US$1,706 and will rise to US$2,364 in 2012.