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- Title
SUSTAINABILITY AND STRATIFIED NONCOMPLIANCE IN THE PHARMACEUTICAL INDUSTRY.
- Authors
Page, Robert A.; Cyr, Danielle M.; Richardson, Anthony S.
- Abstract
The emerging field of strategic sustainability tracks the impact of corporate performance on profits, people and place (environment). Applying this model to the pharmaceutical industry, this paper examines patterns of non-compliance, particularly in regards to product safety (people). This paper explores a key performance indicator (KPI) metrics model for use in a Decision Support System (DSS) to track several major areas of non-compliance. A breakdown of warning letters issued by FDA inspector offices in recent years provides insight into the limitations of non-compliance metrics currently used by the FDA to enforce oversight. The FDA's effectiveness to police non-compliance is undermined by their lack of funding and reactivity, rather than proactive approaches, such as the application of metrics on the supply chain level of analysis. Final investigation shows that regulatory oversight should be proportional to potential profitability of an organization given that larger pharmaceutical companies have more sophisticated supply chain infrastructures which can be used to offload non-compliance risk. Implications are further discussed.
- Subjects
PHARMACEUTICAL industry; KEY performance indicators (Management); SUPPLY chain management; DECISION support systems; UNITED States. Food &; Drug Administration
- Publication
Journal of International Business Disciplines, 2015, Vol 10, Issue 1, p18
- ISSN
1934-1814
- Publication type
Article