FDA Under Pressure to Inspect Foreign Firms - June 21, 2007

An article in the Washington Post states that generic drugs are increasingly being manufactured by companies based in India and China. Analysts estimate that as much as 20 percent of finished generic and over-the-counter drugs, and more than 40 percent of the active ingredients for pills made in the USA, come from India and China.

The article states that experts say medicines from China and India pose a risk of being contaminated, counterfeit or simply understrength and ineffective.

William Hubbard, a former FDA associate commissioner, called the situation dire and deteriorating. "You have this confluence of events, with so much more product coming from abroad and fewer and fewer inspections," Hubbard said. "This is very serious stuff, because a contaminated drug hitting the market could cause lots of injuries or worse before it got tracked down." He also said that the FDA inspection system is so weak that many foreign manufacturers believe they "can play games without consequences."

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