December 19, 2023- Vizient, Inc. submitted comments to the Food and Drug Administration (FDA) in response to its request for feedback on the development of a program aimed at promoting drug manufacturers’ quality management maturity (QMM). Vizient commended the FDA for its ongoing efforts to establish the QMM program and appreciated the opportunity to contribute valuable stakeholder feedback.
Vizient addressed in comments several key questions raised by the FDA including how a QMM program could benefit the healthcare sector, how Vizient could leverage QMM program data, and what barriers to success may exist, among others. Specifically, Vizient discussed potential uses of QMM assessment information, including as part of the sourcing process, to ensure a reliable supply of high-quality pharmaceuticals.
In FDA feedback, Vizient acknowledged the potential challenges of a voluntary QMM program, such as limited participation, and emphasized the need for substantial industry involvement to ensure there is a common methodology by which to judge quality metrics that could be applied broadly.
Vizient remains dedicated to supporting access to medications through various efforts such as by providing solutions and resources and advocating for changes to improve quality, reimbursement, and transparency to help resolve drug shortages and strengthen supply chain resilience.