Ailing FDA May Need a Major Overhaul, Officials and Groups Say

The Obama administration will inherit a Food and Drug Administration widely seen as struggling to protect Americans from unsafe medication, contaminated food and a flood of questionable imports from China and other countries.

Shaken by a series of alarming failures, the FDA desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring, say former officials, members of Congress, watchdog groups and various government reports.

"Everywhere you go, you hear the same chorus: The agency's in trouble," said David A. Kessler, who served as FDA commissioner under Presidents George H.W. Bush and Bill Clinton. "There's a general perception the agency is suffering mightily."

With nearly 11,000 employees and an annual budget of more than $2 billion, the FDA is charged with overseeing products that account for one-quarter of consumer spending in the United States, including over-the-counter and prescription medications, heart valves, stents and other medical devices, the blood supply, and food.

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