Foreign challenges at the FDA

The FDA announced this week that it will start opening foreign offices – first in China and India, and eventually in Latin America, Europe and the Middle East.

It’s a promising step for the agency, which is simply terrible at inspecting foreign plants: Less than 30 percent of foreign drug plants, for example, are checked on schedule. So the FDA deserves a lot of credit for starting the program and investing $30 million to open those offices.

But the announcement leaves some unanswered questions. In the United States, FDA inspectors can walk into any food or drug plant, unannounced, and conduct an inspection. Will they have the same access in countries like China and India, which don’t have a strong regulatory culture? It’s doubtful.

Certainly this is an improvement over the current system: The FDA has to fly personnel into each country for inspections, which are often announced weeks in advance. It’s not perfect, though, and it will require strong cooperation from the host countries. (FDA sources say China and India are receptive to the agency’s efforts.)