Federal auditors testified before a House subcommittee this week that the Food and Drug Administration’s failure to adequately inspect imported medical devices and food has resulted in an agency that is not able to protect Americans from tainted products.
The FDA is responsible for ensuring the safety of 80 percent of the nation’s food supply, about 15 percent of which is imported. The agency also oversees all the medical devices and medicines that Americans use.
In testimony before a House Energy and Commerce investigations subcommittee Tuesday, auditors for the Government Accountability Office, the investigative arm of Congress, and experts from an FDA advisory panel said the agency isn’t even close to doing its job properly.
The GAO said if the FDA were to continue at its current pace, it would take 1,900 years to inspect every foreign food plant and 27 years to inspect every foreign manufacturer that sells medical devices to the United States, The New York Times reported.
The FDA lacks a detailed plan for getting its inspections done, the GAO said, and its computer system is so antiquated that FDA officials don’t know how many foreign plants are exporting goods to the United States and cannot produce a list of the plants that have not been inspected.
Peter Barton Hutt, a former FDA lawyer who testified Tuesday, called the FDA “a fundamentally broken agency.”
Experts from the FDA’s Science Board, an advisory panel that issued a report on the agency’s performance in December, said the FDA doesn’t have the staffing or the technology to ensure that the U.S. food supply is safe. The report was included in a broader review showing that the FDA is lagging in scientific advances and is woefully underfunded.
It is difficult to determine how to fix an agency that has been allowed to deteriorate to such a state. For a start, the FDA must give Congress a detailed timetable describing how it intends to fix these problems and include a realistic estimate of how much it will cost. Congress, in turn, must adequately fund the effort.
The FDA’s job is too important to do otherwise. As the FDA’s own Science Board concluded, American lives are at stake.
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