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FDA plans to initiate its quality metrics program as industry continues to push back.
FDA expects to start collecting quality metrics data from biopharmaceutical manufacturers at the beginning of next year to help it assess how well a firm can measure key elements of a quality drug production operation. The agency’s current plan is to launch the initiative in January 2018 by opening an electronic portal that will accept metrics data for 2017. FDA staffers will keep the portal open for three months and then will evaluate and compare the data and issue a report later in the year.
The agency published a technical conformance guide in 2016 with information on how manufacturers can submit the metrics data electronically when the e-portal becomes operational. A revised technical guidance should be issued in the coming months to further clarify issues related to data submission. FDA then will publish an announcement in the Federal Register early next year stating that the portal is open and providing further updates on what information to submit.
Agency officials hope the quality metrics initiative will identify and reward those firms able to demonstrate that their systems can consistently produce high-quality products, and thus merit reduced regulatory oversight in terms of fewer or shorter plant inspections and more flexibility on postapproval manufacturing changes. The broader goal is to identify potential risks in the supply chain more effectively to detect early signals of possible drug shortages or recalls. Ultimately, the program also would encourage those companies with less robust quality measures to invest more in systems, methods, and personnel able to improve performance.
Yet as the metrics initiative nears implementation, industry is pushing back, questioning the scope of FDA’s data requirements, the timing of the program’s launch, and what the agency will do with the resulting data. Several industry attendees at last week’s PDA Pharmaceutical Quality Metrics & Quality Culture conference in Bethesda, MD expressed concerns about whether participation is worth the effort involved in revising data systems and establishing complex reporting programs.
FDA officials have sought to meet industry objections by scaling back an initial quality metrics reporting program published in July 2015. A revised draft guidance issued in November 2016 made the program voluntary and slimmed it down to requesting data on only three manufacturing quality measures: lot acceptance rate, invalidated out-of-specification (OOS) rate, and product quality complaint rate. FDA also gives manufacturers the option of reporting metrics by products or by sites.
While most large pharma companies plan to participate in the program and are working to collect the specified metrics data for this year, they voiced skepticism at the PDA conference about whether data on a few production indicators can really inform on risks associated with certain products or sites. The program also proposes to reward biopharma companies that achieve high scores for complete data submission by placing them on a high tier of a metrics “reporters list.” However, industry representatives noted that prospect of falling onto a lower tier of the list due to data problems and reporting delays may discourage many firms from reporting at all.
Despite these concerns, FDA hopes that rolling out this voluntary program now will enable the agency to test and improve data collection through the e-portal, to better assess which incentives encourage firms to participate, and to gain insight on how to use the resulting data to improve inspections and oversight. At the same time, agency officials want to be sure that collection of metrics data does not erect barriers to manufacturers adopting new technology and continuous manufacturing systems.