With Only 4 People in India and China, FDA Can't Keep Tabs on Foreign Drug Factories

Last Updated Nov 4, 2010 9:53 AM EDT

Pfizer (PFE), AstraZeneca (AZN), Eli Lilly (LLY), Novartis (NVS) and others need not worry that the FDA will get tough on their Chinese production facilities: The agency admitted in a recent report that it does not have enough staff to monitor factories opening in foreign countries that supply drugs to the U.S.

The drug business is moving much of its research and manufacturing operations to China, India and other Eastern countries where it's cheaper to do business. Lilly, for instance, announced yesterday that it would open a diabetes research center in Shanghai.

In December last year I reported that the FDA has only two inspectors in China even though at the time there were 714 drug sites in that country. Pfizer alone has about 137 sites in China. The General Accountability Office -- the non-partisan investigative arm of Congress -- reported this year that there are still only two FDA inspectors in China, only two in India, that they can't cope with the workload and won't be able to in the future:

FDA officials acknowledged that the agency is far from achieving foreign inspection rates comparable to domestic inspection rates and, without significantly increased inspectional capacity, its ability to close this gap is highly unlikely.
FDA also indicated that the agency cannot respond to the nation's increasing reliance on the globalization of the drug supply chain, in which manufacturing steps may be outsourced to multiple foreign establishments, at its expected fiscal year 2011 funding level.
That's a public health problem for Americans. In 2008, hundreds of patients were poisoned by contaminated heparin made from ingredients in China. The same supplier -- B. Braun -- recalled more contaminated heparin, an anti-clotting drug, in late October this year. If you really want to scare yourself about how some non-U.S. drug factories operate, read the lawsuit filed by the woman who blew the whistle on GlaxoSmithKline (GSK)'s Paxil factory in Puerto Rico. Managers there collected stray pills in a work hat; turned a blind eye to a black market product diversion operation; and wrote reports in Spanish in the hope that their English-speaking bosses wouldn't figure out what's going on.

While there are only two inspectors in China, the FDA has a "cadre" of 15 who work out of the U.S. (Perhaps keeping them in American lulls foreign factory managers into a false sense of security?) Between them, they only inspected 11 percent of foreign factories in 2009:

At this rate, GAO estimated it would take FDA about 9 years to inspect all establishments on this list once.
In contrast, in that same year, FDA conducted 1,015 domestic inspections, inspecting approximately 40 percent of domestic establishments.
Related: Images by Flickr user David Chartier, CC, and Pharmagossip.