Premier Weighs in with FDA on Quality Program for Drug Manufacturing

Premier submitted comments to the Food and Drug Administration (FDA) on the development of a Quality Management Maturity (QMM) program, which aims to improve manufacturing practices and curb drug shortages. Premier agrees with the FDA that greater focus on supplier quality incentives and rewards, including payment for reliably meeting providers’ supply requirements, is key to incenting manufacturers to participate in healthy and sustainable pharmaceutical markets. However, Premier has serious concerns that a rating system like the QMM may generate unintended downstream consequences that exacerbate drug shortages and create new operational challenges for U.S. healthcare providers. Premier’s comments focus on highlighting concerns with the QMM program as proposed and recommending alternate approaches to creating a gold standard for quality manufacturing, including fully implementing existing authorities to address drug shortages prior to establishing new programs.