FDA Announces Two Initiatives to Modernize Drug Quality Programs

By: Janet Woodcock, M.D., and Michael Kopcha, Ph.D., R.Ph.

Patients expect and deserve high-quality drugs – this means consistently safe and effective medicines, free of defects and contamination. To satisfy these important expectations, the FDA strives to make sure that FDA-approved drugs are manufactured to meet quality standards to ensure that every dose is safe, effective, and capable of providing its intended benefit.

Janet Woodcock

Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research

Quality metrics are used in a variety of industries to monitor the quality control systems and processes that ensure standards are met, and to identify opportunities for manufacturing improvements. For the pharmaceutical industry, the use of quality metrics offers potential benefits to patients, manufacturers, and the FDA – including the potential to better combat drug shortages.

With these benefits in mind, the FDA has announced two new voluntary programs – the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program – in response to stakeholder requests for continued dialogue on quality metrics, and to provide methods for industry to engage and inform the FDA’s use of them in the future. The programs will also help drug manufacturers to gain a better understanding of how quality metrics are a common feature of quality culture, and support improvements in product and process quality.

Feedback from early adopters and manufacturers who implemented quality metrics programs to address manufacturing problems, as well as independent academic research supported by the FDA, indicates that a manufacturer’s overall quality program benefits from the use of quality metrics. Quality metrics, such as data on the rate at which manufactured lots have been rejected for failing to meet established standards, can help manufacturers monitor quality control systems and drive continuous improvement efforts. For the FDA, data on quality metrics can help us better assess risk when scheduling inspections. This has the potential of decreasing the frequency of surveillance inspections for lower-risk establishments and narrowing the focus of on-site inspections conducted.

Michael Kopcha

Michael Kopcha, Ph.D., R.Ph., Director of the Office of Pharmaceutical Quality, FDA’s Center for Drug Evaluation and Research

The proximal cause of many drug shortages are quality issues such as substandard manufacturing facilities or processes. Quality metrics can be useful in identifying situations in which a drug supply disruption may occur, which can help mitigate potential future drug shortages. This will help to reassure patients that quality medicines will be available when they need them.

  • The Quality Metrics Feedback Program solicits information from drug manufacturers and sponsors that have implemented and are currently using quality metrics programs. The FDA is encouraging applicants eligible for Type C meetings as well as abbreviated new drug application (ANDA) holders to submit meeting requests to the FDA to discuss quality metrics for specific products. As part of the feedback effort, the FDA is also beginning a pilot study to gain feedback from other types of establishments where these types of meetings are not applicable, such as active pharmaceutical ingredient suppliers, over-the-counter monograph product establishments, and contract manufacturing organizations (CMOs).
  • The purpose of the Quality Metrics Site Visit Program is to provide on-site, firsthand learning opportunities to the FDA staff involved in the development of the FDA Quality Metrics Program. The Site Visit Program also is intended to provide stakeholders with the opportunity to explain the advantages and challenges they’ve experienced when implementing and managing their quality metrics programs.

The FDA’s new initiatives continue to enhance the focus of the conversation between the FDA and drug manufacturers to better understand – and make use of – quality metrics programs. We are confident these efforts will improve both the efficiency and the effectiveness of drug manufacturing, helping to assure a reliable and high-quality drug supply.

Janet Woodcock, M.D., is Director of the FDA’s Center for Drug Evaluation and Research

Michael Kopcha, Ph.D., R.Ph., is Director of the Office of Pharmaceutical Quality, FDA’s Center for Drug Evaluation and Research

‘Quality Metrics’: FDA’s plan for a key set of measurements to help ensure manufacturers are producing quality medications

By: Ashley Boam, MSBE and Mary Malarkey

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.”

Ashley Boam

Ashley Boam, FDA’s acting Director, Office of Policy for Pharmaceutical Quality, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research

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’s critically important for patients, health care 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 us 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.

Mary Malarkey

Mary Malarkey, FDA’s Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research

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.

We encourage patients, prescribers, industry and others to submit comments regarding our Quality Metrics draft guidance. We’ll also be hosting a public meeting on August 24, 2015. We’ll 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’ll 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.

Ashley Boam is FDA’s acting Director, Office of Policy for Pharmaceutical Quality, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research

Mary Malarkey is FDA’s Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research