2nd UPDATE: GAO: FDA Can't Determine How Much Money It Needs
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--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.
According to a GAO report released Monday, the government watchdog noted that while FDA's funding has increased since 2004, so has the agency's responsibilities.
GAO first raised concerns about FDA's inability to determine how much money it really needs to do its job in a previous report 20 years ago. Congressional lawmakers in both parties have raised concerns about whether FDA has enough money to oversee a growing and increasingly complex array of medical products.
The GAO looked at agency funding and workload from fiscal years 2004 to 2008 in the agency's drug, devices and vaccines and biologics division.
GAO said while the number of adverse-event reports - which help the agency track drug and medical-device safety problems - increased during that time, FDA officials couldn't provide data about how many reports it reviewed, for example.
"Without such information, FDA cannot develop complete and reliable estimates of its resources needs," GAO said.
GAO said the FDA received 522,871 drug-related adverse-event reports in 2008 compared with 426,016 in 2004. Device reports jumped to 588,161 from 189,450 while reports involving biologics also showed large gains. FDA told GAO while they place a priority on reviewing serious adverse-event reports, they receive "substantially" more adverse-event reports than staff can review. The FDA said the adverse-event reporting systems don't allow agency to track whether individual reports have been reviewed.
In a letter to GAO, FDA's principal deputy commissioner, Joshua Sharfstein, said the agency agrees with the need to track staffing and work product to help form budget requests and is putting such systems in place. Of the approximately $2.2 billion FDA annual budget, about $1.7 billion comes from Congress while the rest is collected from drug and medical device makers through user fees.
GAO said the bulk of FDA's funding increase from 2004 to 2008 came from user fees rather than Congress. The additional money was put toward reviews of medical products where the agency was generally able to keep up with statutory time frames for approving products. FDA is required to allocate user fees to medical product reviews, although in 2007 the law was changed to allow the agency to spend some of that money to track safety of approved products.
FDA officials have conceded that other areas not funded by user fees, such as inspections and the review and approval of generic drug applications, fell behind from 2004 to 2008.
Congress approved a $100 million funding increase for FDA in 2009 and the Obama administration has asked for a $240 million increase for the upcoming 2010 fiscal year.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; firstname.lastname@example.org