As I see it

Share this article:

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 obsolescent.

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 scare.

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 restructuring.

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

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in As I See It

Email Newsletters

More in As I See It

As I See It: Patient Centricity

As I See It: Patient Centricity

A patient who is diagnosed earlier and receives the most efficacious treatment is the least expensive

As I See It: FDA's social-media moves

As I See It: FDA's social-media moves

FDA has insisted that its antique regulations can address every new promotional challenge

As I See It: FDA and marketing materials

As I See It: FDA and marketing materials

The more clarity that FDA provides, the more confident companies can be in their medical communications