Jim Edwards reported Friday on BNet that the FDA has all of rwo inspectors in China. From FDA Has Only 2 Inspectors Watching Drug Factories in China.
But the fact that the FDA has just two people to cover a territory 3.7 million square miles in size raises questions about how often those factories and labs will be inspected to make sure the drugs they are producing are safe for Western — or indeed any — patients. An FDA spokesperson said in a statement to BNET:
We have two inspectors for medical products. I must emphasize that in addition to those two in-country inspectors, many U.S.-based FDA inspectors continue to make short-term trips to China to perform inspections.
BNET noted a year ago that Pfizer
alone — the world’s largest drug company — is expanding in China faster than the FDA can possibly visit its facilities. Pfizer’s goal (prior to the merger with Wyeth) was to be in 137 Chinese cities. At the time, the LA Times reported that the FDA had 12 people in China. Which would mean that to inspect Pfizer’s facilities the FDA would have to inspect one site every 2.7 days, and take no vacations or weekends. Here’s the FDA’s historic rate of Chinese inspection for all companies, from 2002-2007, according to the GAO:
The lowest rate of inspections in these 10 countries was in China, for which FDA inspected 80 of its estimated 714 establishments, or fewer than 14 establishments per year, on average.
We don’t know – but hope that Edwards follows up on –
- do these two work together or alone:
- do either speak Chinese?
- If so, what dialects?
- What integrity controls does the FDA have in place?By the same token, what personnel protection does the FDA have in place?
Some of Edwards’ other excellent reporting on these issues: