Measuring Pharmaceutical Quality through Manufacturing Metrics and Risked-Based Assessment

On May 1 and 2, the Engelberg Center for Health Care Reform at Brookings convened an expert workshop, “Measuring Pharmaceutical Quality through Manufacturing Metrics and Risked-Based Assessment.”

Following the passage of the Food and Drug Administration Safety and Innovation Act of 2012, the U.S. Food and Drug Administration (FDA) was authorized to collect pharmaceutical manufacturing quality data from regulated industry as part of the agency’s approach to risk-based oversight. This information will provide FDA important insights in the review, inspection, and surveillance of medical product manufacturing. The implementation of common quality metrics will serve to standardize the collection and analysis of this information, and equip the agency to better anticipate and address quality issues which result in drug shortages and recalls, promote continuous quality improvement in manufacturing, and achieve product quality without extensive regulatory oversight. 

Convened through a cooperative research agreement with FDA, this two-day workshop provided an opportunity for pharmaceutical manufacturers, purchasers, regulators, academics, and other stakeholders to discuss shared goals and objectives for a pharmaceutical quality metrics program, explore potential opportunities and challenges in their implementation, and refine a discussion set of metrics for moving forward.