The U.S. Food and Drug Administration (FDA) recently engaged in a series of discussion meetings with various industry groups, including the PDA Quality Management Maturity (QMM) Taskforce. The purpose of these discussions was to gather feedback from a cross-section of the industry to understand why there is still some hesitancy in participating in the proposed QMM program and gain further insight into what different companies would like to see as incentives and positive reporting outcomes. The PDA QMM Taskforce aims to present a concise summary of the meeting’s outcomes and highlight the ongoing communication between the industry and regulatory agency regarding QMM and the closely interconnected Quality Metrics Program. Given that a decade has passed since the FDA introduced its Quality Metrics Program, we will provide an overview of significant events and milestones to establish context for both quality metrics and QMM.
Timeline of FDA Quality Metric Program and QMM
In 2019, the FDA first introduced the idea of a QMM rating based on evaluating an establishment’s quality practices. This program aligned with the FDA Quality Metrics Program, first introduced in 2013. This initiative also coincided with the FDA’s overarching objective of modernizing its operations, encompassing the adoption of key principles like quality by design and risk-based management, which have since become integral components of our quality systems. As our industry continues to evolve, it experiences a perpetual cycle of transformation and enhancements, as shown in these chronological milestones that showcase substantial growth and maturation of the FDA QMM Program:
- 2013 – The FDA proposed the Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments (78 FR 9928) regarding drug shortages and ways to improve their strategic plan. Some highlighted questions asked the industry what manufacturing quality metrics manufacturers use to monitor production and what metrics are useful for value-driven decisions.
- 2015 – The FDA issued its first draft guidance, Request for Quality Metrics Notice of Draft Guidance Availability and Public Meeting; Request for Comments (80 FR 44973), describing a proposed mandatory program for product-based reporting of quality metrics.
- 2016 – The FDA published a revised draft guidance, Submission of Quality Metrics Data; Draft Guidance for Industry; Availability; Request for Comments (81 FR 85226), as an initial voluntary reporting program based on stakeholders’ feedback to the 2015 draft guidance (80 FR 44973).
- 2019 – The FDA published its white paper, Drug Shortages: Root Causes and Simple Adherence to Potential Solutions, which was revised a few months later in this revision. It also introduced QMM as a proposed rating system to be adopted by drug manufacturers for the first time.
- 2020 – FDA launched two voluntary pilot programs:
- Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers; Program Announcement (85 FR 65824).
- Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for Foreign Facilities; Program Announcement (85 FR 65828).
- 2022 – The FDA published Lessons from CDER’s Quality Management Maturity Pilot Programs, where the two pilot program’s profiles were foreign sites manufacturing active pharmaceutical ingredients and domestic sites manufacturing Rx and OTC finished dosage products.
- 2022 – The FDA published Benchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain Resilience, where over 200 global pharmaceutical manufacturers participated in a quality benchmarking study of certain quality metrics and their relationship to QMM.
- 2023 – The FDA published Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals white paper, highlighting the steps to QMM and its considerations for a QMM rating system.
- 2023 – The FDA published CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, where the Office of Pharmaceutical Quality explained it is developing its QMM Assessment Tool (protocol and rubric) to evaluate how effectively establishments monitor and manage quality and quality systems and clarifies what it is not trying to measure.
Details on the Collaboration Between the FDA and PDA Task Force
The FDA has actively sought engagement with industry associations, fostering a collaborative environment throughout the development of its QMM program. It was an honor for the PDA QMM Taskforce to contribute our valuable insights to the FDA’s ongoing efforts in advancing QMM. The PDA QMM Taskforce is comprised of a diverse group of members, including innovators, generics and vendors, who dedicated considerable effort to thoroughly prepare for the meeting. In June, the PDA QMM Taskforce was invited to meet exclusively with members of the FDA to provide our collective feedback on the following questions:
- Given the industry’s range of views on the FDA QMM Program, and based on your experience developing tools or programs that focus on advancing pharmaceutical quality or adopting more mature quality practices, what do you think could be barriers to adoption? Why do you think these barriers exist?
- What advantages do you anticipate can be gained from the FDA QMM Program from the perspective of different stakeholders that your sector will gain from the FDA QMM Program?
- Do you anticipate any unintended consequences, roadblocks, or other concerns with the FDA’s rollout of a QMM program?
- When thinking about QMM outcomes, scores and ratings, what are your thoughts about transparency to stakeholders? Does your perspective change when considering the viewpoint of purchasers or healthcare providers? Can you suggest a “happy medium” for transparency?
- Increased regulatory flexibility is one possible incentive, but this does not apply to all types of manufacturers. In addition, we have heard mixed views on whether reduced surveillance inspection frequency would be a meaningful incentive. What incentives would most successfully encourage participation in a voluntary QMM program? Do you think sector-specific incentives will be needed?
- Is there anything else you would like to add? Is there something that FDA would benefit learning from you on this topic?
Some of the highlights include robust discussion on the need to consider the sensitivity of the report output. It was recommended that the participating establishment maintain ownership of the output and decide its distribution. There was also a healthy discussion of the desired incentives and advantages for those participating. Furthermore, participants expressed how they vary in their manufacturing capabilities (e.g., small molecule, biologics, cell/gene therapy, contract manufacturing organizations, generics, biosimilars, etc.), which should be considered when the FDA is developing this program. This QMM program may not be a one-size-fits-all model but needs to be flexible in accommodating a variety of modalities. The PDA QMM Taskforce also emphasized that the FDA must explicitly state that the QMM rating does not reflect a product’s compliance status but rather a maturity assessment for the establishment facility.
The FDA expressed its sincere appreciation to the PDA QMM Taskforce for a highly constructive and fruitful meeting. The FDA conveyed its commitment to carefully evaluate and incorporate the valuable feedback received as they further refine and consolidate the QMM program. The taskforce, in turn, eagerly awaits forthcoming updates from the FDA and will actively pursue future collaborative endeavors to ensure a continued partnership with the regulatory agency.