January 22, 2009 / 7:39 PM / 10 years ago

Agency questions FDA ability to protect public

A pharmacist in a file photo. REUTERS/Mark Blinch

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.

“We need your partnership to reshape the agency and to provide us with the resources and legislative authorities necessary to support our work,” Acting FDA Commissioner Dr. Frank Torti told members of Congress in a statement dated January 21.

In response to the GAO report, FDA spokeswoman Karen Riley said, “Ensuring that the food and the medical products Americans use are safe is among the highest priorities of the FDA.”

GAO investigators said the FDA needs to have better data on its inspections of facilities in other countries and conduct more inspections.

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.”

The GAO updated list is on its website here

Reporting by Susan Heavey, editing by Maureen Bavdek, Toni Reinhold

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