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.

PREEMPTION DEFEATED IN LEVINE CASE

Supreme Court Sides With Plaintiff and Vermont, 6-3

The above is a headline I never thought I would be writing, at least not this decade. I have not had time to read beyond the overall summary. But it does appear that every major pro-preemption argument was rejected by the 6-3 majority, including the capacity of Wyeth to have independently warned and the intent of Congress that FDA regulations _not_ preempt state tort law. The opinion below:

http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf

No doubt, there will be more to say later--just got this ten minutes ago.