Asked By: Algester
363 days ago

Who regulates the regulator ? Is your new food ok ?

The US Food and Drug Administration, has been criticised by auditors for failing to track its workload, which has rendered it unable to estimate what resources it needs to fulfil its responsibilities.

A report by the US Government Accountability Office says, "The FDA reports that it cannot do all that is asked of it and our analysis of the agency’s activities confirm this."

The report calls on the FDA commissioner "to establish a comprehensive and reliable basis to substantiate the agency’s estimates of its current and future resources." It called on the commissioner to take four actions: assess the agency’s staffing, including its workforce of contractors; gather data on the work the agency conducts to fulfil its responsibilities; assess the extent to which the agency is meeting its
responsibilities, and develop an evidence based estimate of the resources needed to fulfil all its responsibilities.

The report notes that the FDA relies on industry fees for reviewing new products but does not have parallel increases in funding to follow products after they have been approved.