GAO report: FDA lacks expertise for estimating its own budget needs

fdaAccording to a Monday report released by the US government watchdog, the Government Accountability Office (GAO), the Food and Drug Administration (FDA) lacks the expertise required for estimating its own budget needs.

With the FDA struggling to execute its regulatory duties, several lawmakers and consumer advocates have been long complaining about the agency's lacks the staff and equipment. However, the recent GAO report has also brought to light the fact that FDA does not even have "the data to develop a complete and reliable estimate of the resources it needs."

The congressional investigators, who examined the agency's funding and workload during the period 2004-2008 in its drug, devices and vaccines and biologics division, came to the conclusion that FDA fails to make a reliable forecast of the finances it requires for regulating medical products because its staff cannot keep a track of all the adverse-event reports that the agency handles.

The GAO report said that FDA's 'lopsided budget' has more resources diverted towards the approval of new products, with near-negligible attention to the tracking of the safety of the products upon their arrival in the market.

Acknowledging the problems uncovered by the GAO, the FDA Deputy Commissioner Dr. Joshua Sharfstein said: "We have to be able to talk about the funds we need, and how we're using the money, with more detail than FDA has in the past."