(GAO: Washington) – The Food and Drug Administration (FDA) was added to the U.S. Government Accountability Office (GAO) biennial update list of federal programs, policies, and operations that are at “high risk” for waste, fraud, abuse, and mismanagement, or in need of broad-based transformation.

“The three areas added to this year’s High-Risk List are all vital to the public’s well being,” says Gene L. Dodaro, acting comptroller general of the United States and head of the GAO. “It’s clear that basic changes are needed to how the federal government regulates the financial system, oversees medical products, and assesses and controls toxic chemicals.”

The list is updated every two years and released at the start of each new Congress to help in setting oversight agendas. Recent Congresses and administrations have been particularly alert to GAO’s High-Risk List and have used its findings to help tailor agency-specific solutions as well as broader initiatives across government.

Cited as problematic and the reason for its high-risk designation is the FDA’s inability to guarantee the safety and effectiveness of drugs, biologics, and medical devices. As a result, the U.S. consumer may not be adequately protected from unsafe and ineffective medical products. New laws, the complexity of items submitted to FDA for approval, and the globalization of the medical product industry are behind FDA’s failure to ensure product safety,

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