Premier Comments to 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. The program aims to improve manufacturing practices and limit drug shortages. Premier agrees with the FDA that more focus on supplier quality incentives and rewards, including payment for reliably meeting providers’ supply requirements, is key to incenting manufacturers to participate in sustainable pharmaceutical markets.

Though, Premier has concerns that a rating system like the QMM may generate unintended downstream consequences that worsen drug shortages and create new operational challenges for U.S. healthcare providers.

Premier has a link to the comments.