(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,

The GAO has suggested that to improve its standing, the FDA needs to update the data it uses to manage the foreign drug inspection program, do more inspections of foreign establishments that manufacture drugs or medical devices, more systemically review the claims made in drug advertising and promotional material, and ensure that drug sponsors accurately report clinical trial results.

Dodaro released the 2009 list (GAO-09-271) at a bipartisan briefing on Capitol Hill with leaders of the Senate Homeland Security and Governmental Affairs Committee and the House Oversight and Government Reform Committee.

“The Department of Defense continues to dominate the High-Risk List. The military’s lack of progress is of growing concern to GAO. DOD owns eight areas on the High-Risk List outright, and it shares government-wide responsibility for an additional seven areas,” Dodaro said.

Also added to the High-Risk List were the U.S. financial regulatory system, the Environmental Protection Agency, and the Federal Aviation Agency.

The 2009 High-Risk List is available online at www.gao.gov/docsearch/featured/highrisk.html.

For further information, visit www.gao.gov/press/highrisk20090122.pdf.