Experts: FDA Ripe for Sweeping Change

WASHINGTON — 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 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 medicines, heart valves, stents and other medical devices, the blood supply and food.

But morale within the FDA, along with its credibility outside, has plummeted as the agency has been stretched to keep pace with its responsibilities and riven by accusations of ideological bias, a tilt toward industry rather than consumers, and internal dissension.

"FDA is close to being at a tipping point — the agency is hanging on by its fingertips in protecting us," said William Hubbard, who worked for the agency for 27 years. "If something is not done, they could become a failed institution, and no one wants that. The FDA is not only important to protecting the public health, but also to the industries it regulates."

Source: The Washington Post