The General Accounting Office of the United States has placed the FDA on list of "high risk" areas.Agency questions FDA ability to protect public Thu Jan 22, 6:34 pm ET Reuters – WASHINGTON (Reuters) – The U.S. agency responsible for keeping the public safe from harmful drugs and foods was added to a list of "high-risk" areas of the federal government because it may not be able to adequately do its job, the Government Accountability Office said on Thursday.
The GAO said the U.S. Food and Drug Administration (FDA) was being hampered by globalization, more complex products and laws that have made it more difficult for the FDA to ensure the safety of pharmaceuticals, biologic drugs and medical devices.
The GAO releases this list at the start of each new Congress to help lawmakers set priorities.
The Institute of Medicine and advocacy groups have noted challenges to the FDA's ability to keep dangerous and ineffective products off the U.S. market. The FDA itself has acknowledged that it needs retooling.
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It also must "more systemically review the claims made in drug advertising and promotional material, and ensure that drug sponsors accurately report clinical trial results."
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