FDA needs to inspect more foreign drugs, GAO finds

A new report from the Government Accountability Office has estimated that the FDA only inspects about 8 percent of foreign manufacturing establishments that provide drugs to be sold in the United States, a percentage that is far too low to protect the U.S. public, the agency suggests.

The report is part of the GAO's ongoing campaign to force the FDA (and by extension, Congress) to expand the agency's staffing. As of earlier this year, the FDA was reportedly so understaffed that it would need 27 years to inspect every foreign medical device plant, and 13 years to check every foreign drug plan.

Not only is the FDA understaffed, the GAO found that the agency isn't doing a good job of managing its databases, which it says often contain inaccurate information on the foreign establishments that are being inspected. The GAO said that the inspections necessary to make certain that manufacturing plants were complying with corrective actions frequently weren't being updated on a timely basis.

While the GAO contends that making all of these changes would help improve the foreign drug inspection program significantly, to date the FDA has only acknowledged that it recognizes the need to increase the number of inspections.

To learn more about the GAO's findings:
-Read this Modern Healthcare piece (reg. req.)

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