Is a mature pharmaceutical quality system really a competitive advantage?  The industry held this as a belief, but progress in a tangible program was always elusive.  On  November 2nd, the CDER’s advisory committee, Pharmaceutical Science and Clinical Pharmacology Advisory Committee (PSCP‑AC), voted to establish a Quality Management Maturity (QMM) program to incentivize investments in mature quality management practices.  This action is a significant step in the journey towards giving value to product quality rather than just price.

This milestone is a major achievement in answering the call to action contained in the 100-Day Reviews under Executive Order 14017, “Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-Based Growth” (here).  This report specifically calls out pharmaceutical and API manufacturers for an apparent underinvestment in quality management.  The recent vote reflects feedback from the program’s sampled stakeholders who believe overwhelmingly that an incentivized QMM program will lead to greater “continuous improvement opportunities.”  Additionally, a study cited by the FDA in “U.S. FDA Report: Drug Shortages: Root Causes and Potential Solutions” (here) identified that 62% of the drug shortages between 2013 and 2017 were related to quality issues.  The recent global pandemic has not only exacerbated this known issue, but accelerated the global impact.

So, what’s next?  It seems logical to start to explore your organization’s readiness and understanding of this paradigm shift that’s about to occur.  Utilizing the industry’s growing maturity in “risk thinking,” these signals should be used as guidance for making tangible investments in QMM.  The emphasis now is on great leadership to set the direction and start the journey to take advantage of all of the possibilities quietly thought of, but now roaring like a lion.  As Winston Churchill stated, “He who fails to plan is planning to fail.”

If you have any questions or need guidance regarding your firm’s readiness, please contact Lachman Consultants at LCS@LachmanConsultants.com.