Barely a month after the FDA's Science Board Advisory
Committee unanimously declared that “American lives are at risk” because of a
growing crisis in the agency's ability to meet its responsibilities, President
Bush in December quietly signed into law a huge increase in the agency's
budget—$79 million or nearly twice the raise he had asked for.
The outside advisory committee found that FDA's scientific
and regulatory infrastructure has dwindled over the years and become
Their report placed most of the blame on decades of miserly
congressional appropriations for FDA, but the real fault lies with an overly
broad “trim the government fat” syndrome at both ends of Pennsylvania Avenue.
Grassroots efforts among all FDA constituencies brought
sufficient pressure on Congress last year to reverse the budgetary tide at
least for FY 2008, setting the FDA's appropriation at a record $1.73 billion.
It provides increases amounting to $7.5 million for the
critical path initiative; $21.2 million for drug safety operations; $6 million
for generic drug reviews; $4 million for pandemic influenza preparedness; and
$4 million for reviewing DTC ads.
The new budget blocks using any appropriated funds for
shutting down and consolidating field laboratories, a misguided FDA initiative
that attracted bitter controversy during last year's contaminated imports
The new law also encourages the FDA to improve its MedGuide
program in collaboration with outside interest groups, and to be more cautious
about allowing health claims on foods and dietary supplements.
These are all incremental steps in the right direction, but
restoring the FDA to its proper role will take billions more and organizational
Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)