By: Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER) and Patrizia Cavazzoni, MD, Director of CDER
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.
The development of a framework to objectively assess and rate the QMM of manufacturing sites comes on the heels of other agency initiatives and is a result of collaboration with industry and other groups to mitigate drug shortages. For example, the FDA has created a Quality Metrics Initiative to incentivize continual improvement at manufacturing facilities, and has funded research on quality management practices. While quality metrics are a key aspect of a mature quality management program, research findings have shifted the conversation from quality metrics toward a more holistic approach that integrates metrics with other behaviors and attributes indicative of mature quality management.
The Benefits of Transparency
The recently published white paper explains the need for a QMM program. It also covers key elements of such a program, which include an objective, standardized and validated assessment tool; a transparent, universally understood rating system; and clear incentives for industry to achieve higher ratings. We conducted two pilot programs with pharmaceutical manufacturers and are using the feedback from these programs to inform the criteria used to objectively measure a manufacturing site’s QMM. We will continue to seek feedback on this effort as the program evolves.
A transparent rating system will benefit all parties in the drug supply chain. For example, drug purchasers and payors (e.g., insurance companies) will get more insight into the supply chain of the drugs they buy or reimburse. As a result, they will benefit from quality ratings backed by FDA insight to help inform their decision-making and they will have less need to respond to drug shortages. Meanwhile, pharmaceutical companies will benefit from more resilient supply chains. Most importantly, patients, pharmacies, and healthcare professionals will be less at risk of being impacted by quality-driven drug shortages.
Let’s be clear: the need for QMM ratings does not mean that substandard drug products are on the market. The FDA assesses product quality in regulatory submissions and monitors the quality of drugs to provide a high level of confidence in products on the market. A rating system will let the FDA do our job better. That is because the agency will be more informed about the quality management practices at manufacturing sites, allowing for better resource allocation decisions (e.g., inspection timing and frequency) and regulatory flexibility (e.g., for post-approval manufacturing changes).
We also see this rating system as motivation for parties in the drug supply chain to enhance their operations, if needed. With a transparent rating system in place, drug manufacturers with strong marks will be at a competitive advantage and manufacturers with lower ratings will be encouraged to improve their processes. At a collective level, the rating system will help the pharmaceutical manufacturing sector move beyond current good manufacturing practice regulations, which are minimum requirements for the methods, facilities, and controls used in manufacturing drugs. Instead, manufacturers will strive for proactive, above-the-bar behaviors, and sustainable quality management systems.
Small Business and Industry Assistance - Meeting to Engage Stakeholders
As mentioned, the FDA will hold a two-day workshop this month for stakeholders to learn more about a quality management program and to engage with the agency. The workshop is hosted by the Center for Drug Evaluation and Research’s Small Business and Industry Assistance and will include speakers and panelists from outside the FDA to discuss quality management maturity.
The agency invites pharmaceutical purchasers, distributors, wholesalers, manufacturers, international regulators, and other interested parties, to attend these workshops. In the future, we hope to have other opportunities to share ideas and accept feedback on this topic. Working together, we will continue to help ensure that patients and consumers have access to high-quality drugs. To that end goal, the FDA and its partners are fostering a greater commitment to quality in pharmaceutical manufacturing through this QMM program.