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FDA must budget better

The US Government Accountability Office has called on the Food and Drug Administration to improve the way it estimates its funding requirements

The US Government Accountability Office (GAO) has called on the Food and Drug Administration (FDA) to improve the way it estimates its funding requirements.  

In a new report it states that much of the agency's budget is going towards the approval process for new drugs and there are insufficient staff resources for reviewing adverse event reports for marketed products. 

FDA officials admitted that they receive more adverse event reports than staff can review but could not supply data to show whether or not an individual report had been reviewed or how many adverse event reports had been processed. 

The GAO recommends that the agency assesses staffing levels, establishes the work required of it, determines how well it is meeting its responsibilities and provides a data-backed estimate of the resources it needs now and in the future.

Dr Joshua Sharfstein, FDA deputy commissioner, 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."

The Obama administration's fiscal year 2010 budget proposal would increase the agency's federal funding by more than 14 per cent, to $2.35bn. Dr Sharfstein said that FDA officials are already working to monitor more closely how this money would be spent.

21st July 2009

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