FDA Launches Public System to Monitor Its Own Performance

September 9, 2010
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration launched last week a performance management system designed to advance President Obama's commitment to transparency, public participation, and governmental collaboration.

The US Food and Drug Administration launched last week a performance-management system designed to advance President Obama’s commitment to transparency, public participation, and governmental collaboration. Called FDA-TRACK, the system will monitor more than 100 FDA program offices using data from key performance metrics, according to an agency press release. Data will be gathered monthly, analyzed, and presented each quarter to FDA senior leadership. The system is called FDA-TRACK because the public will be able to view the data on FDA's website and track the agency’s progress in meeting established goals.
“It gives managers and employees a new way to measure their effectiveness in meeting goals to protect the public health and provides a way for the public to monitor agency activities,” said FDA Commissioner Margaret Hamburg in an Aug. 31, 2010, FDA press release.
The system will monitor four areas, according to the release:

  • Common Measures: These are agencywide measures may focus on the agency’s recent priorities such as the number of employees who have been trained in the Incident Command System, which helps the agency respond to emergencies.

  • Key Center Director Measures: These measures are center-specific and may focus on targets such as increasing the number of technical publications (e.g., guidance) drafted for industry.

  • Program Measures: These program/office-specific targets will reflect work important to the public and to FDA’s mission such as monitoring the percentage of 510(k) decisions that meet the 90-day Medical Device User Fee Act goal during a specific time period.

  • Key Projects: Finally, these program/office-specific key projects will be measured based on achieving stated milestones within a project plan such as the development of a new risk-based approach for evaluating safety, effectiveness, and quality of new animal drugs.

On a related note, the agency launched an information-technology system to monitor imports coming across US borders last February.