Is the FDA even worse off than we thought? A new report from the Government Accountability Office says that the agency's data-tracking is so poor that it can't reliably estimate how much money it needs to do its job. One of those missing chunks of data is the number of adverse event reports it handles, which by itself is a scary thought.
The GAO report looked at agency funding and workload from 2004 to 2008, finding that the number of adverse event reports increased but the agency didn't track how many of those reports it actually reviewed. Drug-related adverse event reports climbed to 522,871 from 426,016 over the time period, while device reports more than doubled to 588,161. FDA told the GAO that it doesn't have enough staff to review all the reports--and the system doesn't allow reviewers to track which reports have been dealt with.
Deputy Commish Joshua Sharfstein (photo) said FDA agrees that it needs to do a better job tracking its staffing and the work they do, adding that the agency is working to create the systems to do so.
To be fair, the GAO blamed some of the agency's lack of proper data-generation on funding. By forcing the agency to rely on user fees for much of its revenue, Congress created an environment where the industry-funded parts of the agency work better than those not supported by industry money.
- read the Wall Street Journal story