Barely a month after the FDA’s Science Board AdvisoryCommittee unanimously declared that “American lives are at risk” because of agrowing crisis in the agency’s ability to meet its responsibilities, PresidentBush in December quietly signed into law a huge increase in the agency’sbudget—$79 million or nearly twice the raise he had asked for.

The outside advisory committee found that FDA’s scientificand regulatory infrastructure has dwindled over the years and becomeobsolescent.

Their report placed most of the blame on decades of miserlycongressional appropriations for FDA, but the real fault lies with an overlybroad “trim the government fat” syndrome at both ends of Pennsylvania Avenue.

Grassroots efforts among all FDA constituencies broughtsufficient pressure on Congress last year to reverse the budgetary tide atleast for FY 2008, setting the FDA’s appropriation at a record $1.73 billion.

It provides increases amounting to $7.5 million for thecritical path initiative; $21.2 million for drug safety operations; $6 millionfor generic drug reviews; $4 million for pandemic influenza preparedness; and$4 million for reviewing DTC ads.

The new budget blocks using any appropriated funds forshutting down and consolidating field laboratories, a misguided FDA initiativethat attracted bitter controversy during last year’s contaminated importsscare.

The new law also encourages the FDA to improve its MedGuideprogram in collaboration with outside interest groups, and to be more cautiousabout allowing health claims on foods and dietary supplements.

These are all incremental steps in the right direction, butrestoring the FDA to its proper role will take billions more and organizationalrestructuring.

Dickinson is editor of Dickinson’s FDA Webview (fdaweb.com)