FDA needs to refocus plant inspections, GAO says

The federal government watchdog says the FDA has its inspection priorities out of whack. The Government Accountability Office took a look at the agency's inspection records and decided the FDA still isn't inspecting enough foreign facilities, and its approach to increasing those inspections is wrongheaded, Pharmalot reports.

The FDA emphasizes inspections of U.S. facilities over foreign ones, the GAO says. And it focuses on plants listed on new drug applications, rather than on those already turning out medications for sale in the U.S. What this means is that, with FDA's limited resources, the agency is only chipping away at its list of thousands of never-before-inspected drug plants in other countries.

Only 11 percent of the foreign plants on FDA's priority list were inspected in fiscal 2009, for instance. That amounts to 424 inspections. Meanwhile, the agency examined more than a thousand U.S. facilities, or 40 percent of the total.

Health and Human Services countered that if the FDA inspected foreign facilities as often as domestic ones, the frequency of inspections across the board would be about once every seven years. But GAO says it's not suggesting that sort of taking-turns approach. Rather, it wants the FDA to set new priorities. Focus on plants that make drugs most likely to endanger public health if manufactured badly--wherever those plants happen to be located.

- read the Pharmalot post

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