Auditors criticise FDA for failing to track adverse events and workloadBMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b3031 (Published 24 July 2009) Cite this as: BMJ 2009;339:b3031
- Janice Hopkins Tanne
- 1New York
The US medical regulation and safety body, the 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 …