The “Case for Quality Initiative” is a strategic priority for the US Food and Drug Administration. To support this initiative, the agency is working to implement policies that go beyond compliance with regulations and provide an enhanced focus on the manufacturing quality.
To learn more about this strategic shift at FDA, I spoke with Steve Silverman, Director of the Office of Compliance at the FDA’s Center for Devices and Radiological Health.
In this, the final article of this series, Mr. Silverman discusses how firms can demonstrate to the Agency their commitment to quality. We also discuss FDA’s shift from “lagging” to “leading indicators,” and outline next steps for Case for Quality Initiative.
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Read the interview below:
Matlis: FDA seems to be shifting its focus from the “lagging indicators”, like recalls and other adverse events, to “leading indicators” related to quality and manufacturing to improve product quality and safety. Is that the case, and if so, can you elaborate on this transition?
Silverman: I think that is definitively the case. We will never get away from lagging indicators. And lagging indicators have value; they serve an important role. Being aware of the causes of recalls, trends with respect to recalls, and the results of inspections, are critical mechanisms to understand and react to problems that may have developed in the marketplace. But that is not the only approach that we can or should apply. It is equally important to understand what are the predictors of quality outcomes – what are the practices that manufacturers undertake when they are implementing quality correctly, which create a high likelihood of a quality product that serves its intended use.
Our understanding of what those practices are is evolving. As I mentioned before, part of the purpose of our pilot program around implantable devices that contain batteries is to allow us to engage in dialogue with manufacturers about what are those leading indicators of quality and to apply the learnings from those conversations, both to our internal operations and, we hope, to operation that manufacturers undertake. But this is a process that is still in its relatively early days and I think that our ability to identify and incorporate leading indicators is very much a work in progress.
Matlis: How can firms demonstrate to the Agency their commitment to quality?
Silverman: We have heard very positive reaction from industry about the Case for Quality Initiative. Both the larger idea that the Agency and industry member should be able to work together collaboratively to identify Quality Practices and more specific reactions to some of the proposals that we have developed, like differentiating manufacturers based on their overall quality capability and interacting with them on the basis of that differentiated assessment.
To be successful, there has to be strong, ongoing collaboration between the Agency and stakeholders. And so what are we are looking for, and what we need in the near-term, is manufacturers finding ways to come together to interact with the Agency around quality-related topics. And those interactions may take the form of the venue that I described earlier with dialogue around quality-related topics or those interactions that can occur entirely independent from FDA with the output of those interactions being brought to the Agency for its consideration. There is nothing that prevents individual manufacturers or groups of manufacturers from undertaking on their own analyses of quality-related practices or mechanisms for advancing quality and bringing to the Agency the results of those reviews for our information and for incorporation into this larger quality-based effort.
Matlis: What are some of the next steps for Case for Quality Initiative?
Silverman: We are going to continue our work on the pilot program that relates to implantable battery-containing devices. We are going to use the learnings from that pilot program to expand our interactions with industry and other stakeholders around quality. We are going to work diligently to identify and establish a forum in which we can have continuing discussions with a defined set of stakeholders around identified quality-related topics in order to develop our understanding of and actions around quality-related design and manufacturing. We are going to look for mechanisms to organize and present quality-related data in a way that informs the dialogue between FDA and manufacturers around quality and that supports manufacturers’ individual quality-related efforts, whether by making available data for discussion between the Agency and stakeholders, or making that data available for analyses that are undertaken independently by manufacturers or associations on behalf of manufacturers.
In Part I of the “Executive Perspective” series, Mr. Silverman provides an overview of the Case for Quality Initiative, driving sustained conversations with industry to improve device quality.
In Part II of the series, we discuss the expected benefits of Case for Quality Initiative for FDA and industry as well as the role metrics and analytics play in support of the Case for Quality Initiative.