FDA Has Only 2 Inspectors Watching Drug Factories in China
The FDA has only two inspectors for medical products in China, the country to which much of the drug industry is moving its manufacturing and R&D facilities. The FDA confirmed the number at the request of BNET, following reports that Pfizer (PFE), AstraZeneca (AZN), Eli Lilly (LLY) and Novartis (NVS) were moving a variety of functions to the country.
Even as pharmaceutical jobs move to China, the U.S. and Europe remains the industry's major market. At many international companies America accounts for half of all drug sales. Even though China has a reputation for producing shoddy, sometimes poisonous drug products in a business environment that lacks transparency, companies continue to move R&D and production facilities there because it is so much cheaper than the West. BNET recently noted:
- AZ moved 300 manufacturing jobs to China.
- Pfizer added 200 jobs in Wuhan.
- Eli Lilly moved 2,000 jobs to China.
- Novartis added a $1 billion facility in the country.
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.With just two people to inspect 714 facilities, it would take each individual staff member almost exactly one year to visit each site once, with no days off. Or, collectively, it would take about two years for the FDA to visit each site once, at a rate of one visit per day.
Download the GAO's report on FDA inspection of foreign drug facilities here.Failure to inspect foreign drug labs and factories carries a high price. In 2008, 81 Americans died from tainted heparin, a blood thinner, that was manufactured in China. The FDA has continued to approve drugs manufactured by the Indian company Ranbaxy despite finding that the firm had faked test results submitted to the federal agency.