Expert witnesses told Congress this week that the FDA's capacity to safeguard drugs and devices is in peril. It was an internal FDA advisory board that came to that conclusion and reported findings to a House Energy and Commerce subcommittee.

The FDA's depleted infrastructure, lack of scientific expertise, low funding, old computers, and other ills that perhaps are all too common in government, conspire against fulfillment of its mission to protect public health.

Regarding devices in particular, a separate GAO report found lax inspection of makers of vital products including pacemakers, stents, and heart valves. "FDA has not met the statutory requirement to inspect certain domestic establishments manufacturing medical devices every 2 years, and the agency faces challenges inspecting foreign establishments," the report concluded.
Recently, high-profile threats to Americans' health have slipped by the agency charged with protecting us, including the approval and withdrawal of Vioxx from the market, concerns over the efficacy of cholesterol-lowering drugs, recalls of pet food, toothpaste and other imported consumables.

In its defense, the FDA commissioned the study by the scientific board, which suggested a reorganization and infusion of cash to the agency. Part of the problem is that many well meaning and stringent laws have been passed in the last two decades without the FDA receiving funding to enforce them.

Read more at

http://www.medicalnewstoday.com/articles/95501.php

and

http://www.gao.gov/docsearch/abstract.php?rptno=GAO-08-428T

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