FDA Taps Smith Expert in Making Case for Drug Manufacturing Efficiency

The Food and Drug Administration has released a study outlining ways to reduce costs, improve reliability and help prevent drug shortages in the pharmaceutical industry, and it cites Smith Enterprise Risk Consortium director Clifford Rossi a key contributor—for “provid[ing] economic expertise and insights about quality management.”

In previous FDA-supported work, Rossi, a professor of the practice at the University of Maryland’s Robert H. Smith School of Business, shows US drug manufacturers would benefit competitively and in terms of supply chain resilience from continuous manufacturing in new facilities domestically, compared to batch manufacturing abroad. He further disseminated the findings via European Pharmaceutical Review and The Washington Business Journal.

Incorporating Rossi’s work and further input, the FDA’s new white paper, “Quality Management Initiatives in the Pharmaceutical Industry: An Economic Perspective,” includes real-world case studies, economic modeling, and analysis of costs across manufacturers, patients, healthcare systems, and society. 

Key points are:

• Incremental investments in quality management systems can yield significant financial returns, reducing product defects and waste while improving resource allocation and operational throughput.
• Mature quality management practices enhance public health by stabilizing supply chains and preventing drug shortages, crucial during high-demand periods like the COVID-19 pandemic.
• A scalable investment model allows companies to gradually improve quality management systems, aligning with business strategies and adapting to regulatory and market changes.

Rossi also has served as a member of the FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee and participated on multiple FDA grants to the University of Maryland.