Healthcare Innovation March 2, 2023
Soumi Saha

The FDA has been pursuing a framework for a pharmaceutical manufacturing site rating program–but could the creation of the Quality Management Maturity program lead to unintended consequences that exacerbate drug shortages?

Industry Perspective

by Soumi Saha, PharmD, Premier Inc.

The U.S. Food and Drug Administration (FDA) has been pursuing a framework for a pharmaceutical manufacturing site rating system, the Quality Management Maturity (QMM) program, which aims to improve operations and curb drug shortages.

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, a rating system like the QMM may generate unintended downstream consequences that exacerbate drug shortages and create...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
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