Incentivizing quality in the manufacture of pharmaceuticals: manufacturers' views on quality ratings

7/8/2015An increasing number of industry‐wide quality breaches and consequential drug shortages have fueled interest in finding better ways to improve the manufacturing quality of pharmaceuticals. Quality metrics offer a way of focusing FDA inspectional resources using risk‐based paradigms, and communicating the quality status of different companies to other stakeholders. This exploratory study investigated industry views related to the use of quality metrics and ratings to help advance these discussions. A 23‐question survey engaged two separate populations of industry professionals, a panel of identified US industry experts (n= 110) and a broader population (n = 328) of professionals at different job levels working in Southern California. Results showed that industry values FDA metrics, such as warning letters and inspectional observations documented in FDA 483s, often characterized as “lagging” metrics. Respondents were generally hesitant to share information that would establish “leading” metrics such as process performance measures that may warn of incipient problems. Ratings were recognized to incentivize higher quality by broadening stakeholder influence. However, concerns were identified related to the equity, misuse, or misunderstanding of the rating schemes and underlying metrics. Industry is an important stakeholder in the development of metrics. Their concerns must be recognized and addressed if policies related to metrics and ratings are to be effective. This study expanded our understanding of industry views regarding the use of quality metrics and ratings, but it also identified areas in need of additional study to help find better ways to incentivize quality and build an industry‐wide quality culture