Vizient Provides Feedback to FDA on Quality Management Maturity for Drug Manufacturing Establishments

IRVING, Texas, December 14, 2023 – Today, 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.

In our comments, Vizient addressed 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.

"The development of a QMM program is a critical step in tackling the multi-faceted challenge of drug shortages," said Dan Kistner, group senior vice president, pharmacy solutions for Vizient. "Vizient has implemented various initiatives to support access to medications, such as daily monitoring of drug shortages using our robust data set, regular publication of our essential medications list, and our Novaplus Enhanced Supply Program, which has enabled health systems to access over 3 million units of critical medications to ensure uninterrupted patient care during drug shortages. We firmly believe transparency is a pivotal element in the prevention and mitigation of drug shortages."

In our feedback to the FDA, 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 also suggested that reimbursement changes may be needed to encourage healthcare providers to utilize QMM ratings in their purchasing decisions, and to prevent costs incurred by suppliers for increased investments in quality and resilience from being absorbed solely by providers.

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.

About Vizient, Inc.
Vizient, Inc., the nation's largest health care performance improvement company, serves more than 60% of the nation's acute care providers, which includes 97% of the nation's academic medical centers, and more than 25% of the non-acute market. Vizient provides expertise, analytics and advisory services, as well as a contract portfolio that represents more than $130 billion in annual purchasing volume. Vizient's solutions and services improve the delivery of high-value care by aligning cost, quality and market performance. Headquartered in Irving, Texas, Vizient has offices throughout the United States. Learn more at www.vizientinc.com.