Knowledge Center

Article / Jun 06, 2014

Why Dr. Hamburg Needs Her Dean鈥檚 List

Authors:
  • Guy Villax
Source:
Guy Villax Letter, June 2014

The quality metrics debate needs to recognize the paramount importance of quality culture over and above the mere compliance that results from meeting a quality system. What is needed is a simple reward system that identifies role models. An FDA鈥檚 Dean鈥檚 List will solve many problems: it will reward those producers that do the right thing for the patient, it will encourage innovation in pharmaceutical manufacturing, it will allow inspection resources to be applied wisely, it will make quality an effective differentiator at a time when the vast majority of manufacturing is done through outsourcing. This paper flags the responsibility of the CEO in driving the organization鈥檚 quality culture: the final safety net that assures patients only get good medicines.