Incentivizing Quality in the Manufacture of Pharmaceuticals

Abstract

Background:

An 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 by 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.

Methods:

A 23-question survey engaged 2 separate populations of industry professionals: a panel of identified US industry experts (n = 110) and a broader population (n = 328) of professionals working primarily in southern California.

Results:

FDA metrics most valued by industry were warning letters and other observations, 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 problems earlier. 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.

Conclusions:

Industry is an important stakeholder in the development of metrics. The concerns of industry must be recognized and addressed if policies related to metrics and ratings are to be effective in building an industry-wide quality culture.