USA – FDA Task Force Recommends Rating System for Drug Manufacturing Quality

The US Food and Drug Administration (FDA) on Tuesday published a new report on the root causes and potential solutions for drug shortages, recommending a new system to measure and rate the quality management maturity of individual drug manufacturing facilities based on objective indicators.

The recommendation to create such a rating system is one of three recommendations made by FDA’s inter-agency Drug Shortage Task Force in its 124-page report, which also recommends creating a shared understanding of the impact of drug shortages and the contracting practices that contribute to them and promoting sustainable private sector contracts.

The need for such a rating system, as discussed in an FDA blog post last week, comes as the task force says the market “does not recognize and reward mature quality management systems” and as it “does not compensate drug manufacturers with price premiums for mature quality management.”

As many manufacturing sites have focused their efforts on compliance with current good manufacturing practices, which FDA says set “a minimum threshold,” companies do not have a need to pursue “more advanced levels of quality management, which aim to robustly detect vulnerabilities and address them in order to prevent the occurrence of problems, nor do they establish a culture that rewards process and system improvements,” which is important as drugs in shortage are typically older drugs, with a median time since first approval of almost 35 years…