An inter-agency task force on drug shortages has recommended developing a rating system for drug manufacturers that would grade them on their “mature quality management,” which includes their reliability. Currently, the report says, manufacturers aim to comply with the FDA’s Current Good Manufacturing Practices and have no incentive to do better.
The report, which was released by the FDA earlier this week, identifies various market failures and pricing as the root causes of drug shortages. A rating system would make the market work better by giving buyers more information and “provide [manfactuers] committed to quality management maturity with a competitive advantage,” says the report, titled Drug Shortages: Root Causes and Potential Solutions.
Source: FDA, October 29