Editor’s Note: This article is written by Ashley Boam and Mary Malarkey from the “FDA Voice” blog. Boam is an FDA’s acting Director of the Office of Policy for Pharmaceutical Quality, the Office of Pharmaceutical Quality and the Center for Drug Evaluation and Research. Malarkey is an FDA’s Director if the Office of Compliance and Biologics Quality and the Center for Biologics Evaluation and Research.
Ashley Boam is an FDA’s acting Director of the Office of Policy for Pharmaceutical Quality, the Office of Pharmaceutical Quality and the Center for Drug Evaluation and Research.
Yesterday, we took an important step in advancing the quality of medications with the release of draft guidance for the pharmaceutical industry called, “Request for Quality Metrics.”
In these technical terms, that may not sound like much. But–in plain language–this document describes a set of measurements to help the agency evaluate the quality of the facilities and the processes that manufacturers use to make FDA-regulated drugs and biologics. These include prescription drugs and certain biological products. The guidance also encourages these manufacturers to conduct robust quality measurements on their own products.
It is critically important for patients, healthcare professionals, caregivers, payers and others to have confidence in how medications are made. “Quality metrics,” or the measures used to assess the quality of drug and biologic manufacturing, can help achieve this goal.
We expect that these measurements will strengthen our efforts to ensure that FDA-regulated medications are not only demonstrated to be safe and effective, but also continually manufactured under strict quality standards.
We believe a careful analysis of quality metrics can help FDA better identify which facilities are at the highest risk for quality problems. This will help us use our inspection resources most efficiently and effectively.
Quality is also directly connected to a consistent supply of needed medications. Over the years, there have been disruptions in the availability of some drug and biological products due to manufacturing production flaws. We believe that a company’s own robust quality measurement system, along with our quality measurements, can help manufacturers better identify factors that may predict manufacturing problems – and move us a step closer toward reducing and controlling these disruptions.
FDA has been working for many years on solutions to encourage and support the modernization of pharmaceutical manufacturing, such as the use of risk-based regulatory strategies for oversight. Our quality metrics initiative is one of several approaches we believe will further support this effort.
Mary Malarkey is an FDA’s Director if the Office of Compliance and Biologics Quality and the Center for Biologics Evaluation and Research.
We encourage patients, prescribers, industry and others to submit comments regarding our Quality Metrics draft guidance. We will also be hosting a public meeting on August 24, 2015. We will use this input to help create a final guidance to support the reporting and calculation of quality measurements.
Yesterday’s draft guidance is an important step on a shared path toward improved drug quality throughout the pharmaceutical industry. We look forward to receiving comments, finalizing the guidance and receiving the first set of reports.
In the meantime, we will be working with others to support industry’s use of robust quality metrics programs and to understand the best way to use quality metrics to improve manufacturing quality and FDA’s regulatory decision making.
We also will continue to emphasize the importance of quality in the pharmaceutical industry for companies that make medications and for the patients who receive them.
FDA Voice
blogs.fda.gov/fdavoice
