GAO calls FDA a 'high-risk' problem

The FDA has earned another dubious honor: It's on the list of the Government Accountability Office's highest-risk regulatory problems. Though much of the news coverage has focused on our woeful regulation of the financial system, everyone's favorite drug agency gets a smackdown, too. According to the new GAO report, the FDA needs to do the following:

  • Improve its data on and management of foreign drug inspections. We're all familiar with these problems, from the big heparin recall early last year to the inspections report that found paltry oversight of overseas manufacturing facilities. Apparently, the agency doesn't even know how many facilities it's supposed to be inspecting. And this at a time when more and more drugs and APIs are made in other countries.
  • Systematically track the marketing materials it needs to review. Audits have found that, by the time FDA gets around to checking out some promotional items and media, they've already hit doctors and consumers. The GAO found that in 2007 the FDA received 68,000 submissions to review, but had no more than 44 full-time staffers assigned to review them, meaning they had to prioritize and review only the most urgent submissions--but didn't have a system for setting those priorities, the Washington Post reports,
  • Do a better job on post-marketing safety. The adverse events reporting system needs help, GAO says, partly because the FDA tends to rely on drugmakers to come forward with safety problems, rather than going out to look for them (that could change with the database the agency is building to track side effects). Plus, the agency often doesn't follow up on required post-market studies, so many of them aren't ever completed--and FDA doesn't keep track well enough, GAO says. 

The GAO acknowledges that the FDA's job has grown more difficult as its resources have shrunk. Given that this report is designed to help Congress set its priorities, will we see some big changes--and big money--at the FDA?

- read the GAO's report summary (.pdf)
- see the Wall Street Journal story
- check out the coverage at the Washington Post