Report cites FDA’s weaknesses over drugs, devices

WASHINGTON (Reuters) - The U.S. Food and Drug Administration, hampered by increasing globalization and a rise in complex products, may not be able to adequately protect the public’s health, the watchdog arm of Congress said in new findings released on Thursday.

“As a result, the American consumer may not be adequately protected from unsafe and ineffective medical products,” the U.S. Government Accountability Office (GAO) said in adding the FDA to its list of “high-risk” areas of the federal government.

New laws were also challenging the FDA’s ability to ensure the safety of pharmaceuticals, biologic drugs and medical devices, it added. The GAO releases its list at the start of each new Congress to help lawmakers set their priorities.

Numerous other groups, including the Institute of Medicine and various advocacy organizations, have cited the FDA’s challenges in keeping dangerous or ineffective products off the U.S. market.

The agency itself acknowledged it needs to be retooled.

“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 said to members of Congress in a statement dated Wednesday.

“For many issues of risk, science does not give us all the answers. When we do not yet know the answers, the FDA will be honest and forthcoming about our uncertainty,” Torti said in his statement, which also addressed consumers, scientists and companies.

Representatives for the agency could not immediately be reached for specific comment on the GAO’s report.

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 said.

The GAO updated list is on its website here

(Reporting by Susan Heavey, editing by Maureen Bavdek)


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