GAO: FDA regulators can't track adverse event reviews

The FDA can't reliably forecast just how much money it needs to operate, says a new Government Accountability Office report, because it can't even track how many adverse drug and device events it investigates.

The GAO report noted that the number of adverse events reported to the agency has shot up in recent years, hitting 522,871 for adverse drug events alone in 2008. That was up from slightly more than 426,000 in 2004. Adverse event reports on biologics also posted a big gain. But while the FDA says reviewing the reports is a priority, the system it has in place doesn't track how many reviews it completes.

The FDA budget is a big concern to the drug development industry, which pays a large share of the load through special fees levied on biopharma companies. The bulk of the FDA's budget hikes over the past four years came from those fees, though the 2009 numbers included a $100 million increase by Congress. The Obama administration is looking for a $240 million increase for next year, in large part due to an increased emphasis on public safety.

- read the story from the Wall Street Journal

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