FDA Report Says Nation's Health at Risk

The agency can't keep up with increasing demands, new technologies, subcommittee finds

By Steven Reinberg
HealthDay Reporter

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FRIDAY, Nov. 30 (HealthDay News) -- A new report by a U.S. Food and Drug Administration subcommittee says the agency can no longer adequately protect the nation's food and drug supply.

The Subcommittee on Science and Technology lays the blame squarely on inadequate funding, which it says has not kept pace with increasing demands on the agency.

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"This imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public," the report states.

And things could get worse, the report stresses: "...the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities."

William Hubbard, a former FDA associate commissioner and an advisor to the Coalition for a Stronger FDA, a group that lobbies on behalf of the agency, called the report "one of the most remarkable reports I've ever seen. They are basically saying the FDA can't protect the public, and they are saying that our future competitiveness in new technology, emerging science and pharmaceuticals and devices is seriously threatened."

Hubbard also thinks that more money is needed for the FDA to do its job. "The number doesn't matter -- it just needs to be a lot," he said. "You would need a steady increase over five years to fix the FDA."

The report started as a review of the science at the FDA, Hubbard said, and mushroomed into something more.

"The committee was horrified that the science wasn't there, then they were horrified that the capabilities weren't there -- and the only way to fix that is funding," he said.

The FDA budget request for 2008 is $1.74 billion, plus another $444 million in user fees. These fees are paid by drug makers and medical device makers to underwrite the approval process of their products.

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