On August 24th, the FDA held a public meeting to discuss its plan to request quality metrics from drug manufacturers. The meeting was the first opportunity for the agency and industry to publicly discuss the plan since FDA released its draft guidance in July.

The draft guidance, Request for Quality Metrics, details plans to use quality metrics data to further develop the FDA's risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, and to improve FDA's evaluation of drug manufacturing and control operations. FDA expects that the initial use of the metrics will be to consider a decreased surveillance inspection frequency for certain establishments; establishments that have highly controlled manufacturing processes have the potential to be inspected less often than similar establishments that demonstrate uncontrolled processes. Additionally, FDA intends to consider whether these metrics may provide a basis for FDA to use improved risk-based principles to determine the appropriate reporting category for post approval manufacturing changes.

While many questions about the program remain, the agency provided some clarification for industry and said it would not be releasing its final guidance until 2016. The agency is also extending the comment period on the draft guidance by an additional 60 days, giving industry until November 27th to submit its feedback. All comments should be identified with the docket number listed in the Federal Register. Additional information is available here.

Last updated: August 31, 2015