The FDA has weathered no small amount of criticism over its lax regulation of food and drug safety overseas. In recent months, it seems that hardly a week passes without reports of the FDA's inability to effectively monitor drugmaking in other countries. As the biotech and pharmaceutical industries extend their global reach, ensuring the quality and safety of imported products is an increasingly important issue.
Now the FDA is doing something about it. FDA Commissioner Andrew von Eschenback is hoping to establish five satellite offices in India, China, Central and South America and the Middle East. Currently, FDA workers periodically inspect foreign pharmaceutical plants and clinical trial sites, but visits are only conducted yearly. The new offices would help provide much-needed extra capacity as well as train additional inspectors.
There are details yet to be ironed out. For one thing, the FDA must decide how its inspectors will work with other countries' own drug approval agencies. There's also the issue of how to finance the whole endeavor--a real issue, considering that the FDA is already operating on a less-than-ideal budget.
- see this article from The New York Times