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Volume 31, Issue 8
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
FDA has struggled for several years to establish a program for collecting data from biopharmaceutical manufacturers that can measure how well a firm produces high-quality products on a consistent basis. Now after months of inaction on advancing a proposed quality metrics initiative, the agency appears to be starting over by asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products. FDA also is proposing that manufacturers invite agency staffers to visit sites to examine more closely a firm’s quality measurement program.
FDA’s quality metrics initiative emerged several years ago as part of agency efforts to encourage industry investment in quality manufacturing systems able to reduce product defects that could lead to drug shortages and recalls. A 2015 draft guidance from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) proposed to collect data on manufacturing operations and product attributes that could help measure how well a firm was able to meet quality standards. In response to multiple comments from industry, FDA issued a revised version of that guidance in 2016, which also drew a harsh response from stakeholders.
The negative comments to these proposals reflect wide disparities in how pharma companies individually measure and track manufacturing operations and product quality. Firms raised concerns that FDA would make the reporting program mandatory, instead of voluntary, and that it was particularly difficult to assess a firm’s “quality culture,” involving how management encouraged and supported methods to quality production. Trade organizations asserted that the proposed metrics program would require substantial industry resources and significant operational changes that could undermine other quality improvement efforts. And there was strong opposition to indications that FDA might publicly disclose metrics data-whether to reward high performers or to encourage others to invest more in quality improvement.
Since then, FDA has been quiet on the metrics issue, even as agency leaders have highlighted the importance of improving drug quality and adopting continuous manufacturing systems. At the ISPE Quality Manufacturing conference in June 2018, industry representatives discussed efforts to advance metrics measurement methods, and experts from the University of St. Gallen provided an update on their model for using metrics to drive continuous improvement and greater efficiencies in pharmaceutical production.
Yet, FDA had little new to report. Tara Gooen-Bizjak, senior science policy advisor in CDER’s Office of Pharmaceutical Quality, had the unhappy task of reporting that “active discussions” about quality metrics were continuing at the agency, and that metrics data were regarded as important for improving quality. She acknowledged that most manufacturers use quality metrics as part of process validation, lifecycle management, and pharmaceutical quality assessment. But she could not say when FDA might issue revised guidance or further proposals on the metrics initiative.
FDA’s recent announcement indicates that the agency is taking a fresh look at how manufacturers use metrics in their internal operations to inform its plan for collecting quality measures. A new Quality Metrics Feedback Program seeks to learn more about quality metrics activities across the industry. Manufacturers of new drugs are encouraged to request a formal Type C meeting to discuss these issues, and generic-drug makers may do so at pre-ANDA (abbreviated new drug application) meetings. Contract manufacturers and companies that produce active pharmaceutical ingredients and over-the-counter drugs may participate in a pilot program to provide feedback on their quality measurement activities.
In addition, a new Quality Metrics Site Visit Program aims to send FDA teams to visit manufacturer facilities that have implemented quality metrics programs, particularly those designed to address significant manufacturing problems. The goal is for CDER and CBER staff to observe how firms gather, collect, and report quality data to management, and for participating establishments to explain the advantages and challenges associated with devising quality metrics programs and to showcase technologies that support such initiatives.
FDA seeks several firms to apply by June 2019 to participate in these voluntary programs. In announcing the new initiatives, the agency says it seeks to “continue learning about the advantages and challenges” companies have experienced with metrics programs in order to inform policy development. One possibility is that metrics data will help devise a more risk-based inspection program that offers decreased establishment inspections for high-quality facilities. FDA also hopes to better identify situations likely to experience supply disruptions. More information on FDA manufacturing quality initiatives can be found at https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/default.htm
Orignially posted online at BioPharmInternational.com July 2, 2018.
Vol. 31, No. 8
When referring to this article, please cite it as J. Wechsler, "FDA Seeks to Revive Quality Metrics Initiative," BioPharm International 31 (8) 2018.