FDA Seeks to Engage Stakeholders on Key Considerations for a Drug Quality Management Maturity Program

Part of the U.S. Food and Drug Administration’s mission is to protect and promote public health by helping to ensure that safe, effective, quality drugs are available to patients. Drugs are not available to patients if they are in shortage. The 2019 report Drug Shortages: Root Causes and Potential Solutions found that a root cause of past drug shortages is that the market does not recognize and reward drug manufacturers that have invested in achieving quality management maturity (QMM). QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes in place to achieve quality objectives and promote continual improvement. Such business processes reduce the likelihood of supply disruptions and shortages.

To incentivize drug manufacturers to invest in QMM, the FDA has released a white paper that describes key considerations for measuring and rating a drug manufacturer’s quality management maturity, and their ability to deliver high-quality drugs reliably and without disruption. A QMM rating system could inform regulators and drug purchasers (e.g., distributors that ship drugs from manufacturers to pharmacies) about the performance and robustness of drug manufacturing facilities and give patients increased confidence in the availability of drugs. We are eager to engage with stakeholders on the development of a quality management maturity program and will be hosting a two-day workshop this month on May 24 and 25 for stakeholders to discuss their thoughts, perspectives and feedback.

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