Adverse Event Reporting - Problem, What Problem?

As reported by the Wall Street Journal on 7/20/2009 - GAO: FDA Can't Determine Its Funding Needs "The Food and Drug Administration isn't able to reliably determine how much money it needs to regulate medical products because, among other things, its staff can't track all the adverse-event reports it handles, according to the Government Accountability Office."

(click on the title to access the full article)

Which is the worse problem? Can't track adverse-event reports or Don't know how much my budget should be to do my job adequately. Either way it sounds like a train wreck in the making.

GAO Has an Opinion of the FDA - Not Good

Add one more in the long line of respected authorities to raise the flag of danger about the FDA's capability to protect the American public.

The Government Accountability Office (GAO) has completed a study of the effectiveness of the FDA and in testimony before Congress concluded.

"...these shortcomings in both premarket and postmarket activities raise serious
concerns about FDA's regulation of medical devices."

The highlights to the report to Congress from the GAO can be found here
The full report to Congress can be found here.