The Food and Drug Administration is among three federal agencies that have been added to the U.S. Government Accountability Offices biennial High-Risk Series report, which identifies programs, policies and operations that are at significant risk for waste, fraud, abuse and mismanagement.
New laws, the complexity of items submitted to FDA for approval and the globalization of the medical products industry are challenging FDAs ability to guarantee the safety and effectiveness of drugs, biologics and medical devices, wrote GAO officials in a news release. As a result, the American consumer may not be adequately protected from unsafe and ineffective medical products.
GAO officials recommended that the FDA improve the quality of the data it uses to manage foreign drug inspections, conduct more inspection of overseas manufacturing facilities and require more-accurate reporting of clinical trial outcomes.
In all, 30 programs and operations appeared on the GAO 2009 High-Risk report. The Environmental Protection Agency along with the financial regulatory system were also added to this years list.