Report to House committee finds imbalance between FDA demands and resources

WASHINGTON The nation’s public health is at risk, as are the regulatory systems that oversee the nation’s drug and device supplies, read an FDA Science Board report presented at a House Energy and Commerce Committee hearing Tuesday.

The committee attributed the deficiencies to soaring demands on the FDA; and resources that have not increased in proportion to those demands. They conclude that “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.”

“Over the last decade, complex scientific advances, globalization and challenging new safety issues have combined to multiply the responsibilities of the FDA,” noted Mark McClellan, former FDA commissioner and chairman of the Reagan-Udall Institute. “As the FDA Science Board report makes clear: our expectations cannot exceed the resources we give FDA to accomplish its mission.”

The result of a year-long review by a distinguished panel of experts, the 300-page report concludes that the state of FDA’s scientific and regulatory programs could not be separated from the lack of resources available to support the agency’s scientific base, hire and train a broadly-capable scientific workforce, and build a sophisticated and modern information technology infrastructure.

“FDA can’t improve its science, prepare for the future, or protect American consumers without significant additional resources,” stated Don Kennedy, another former FDA commissioner and editor-in-chief of Science. “The Administration and Congress are starting now on the FDA’s FY 2009 budget and must fix this critical problem.”

Peter Barton Hutt, who served as the FDA’s general counsel in the 1970s, suggested a doubling of the agency’s $2 billion annual budget and a 50 percent increase in its staff over two years.