Marketing Masterclass: The Rigours of Regulatory Approval: Successfully Navigating a Pharmaceutical Brand Name through the Global Regulatory Environment

Abstract

Pharmaceutical and biotechnology companies face many challenges in the process of developing a product's brand name. Among the myriad issues surrounding the drug name is regulatory review and approval. Government agencies in both the United States (Food and Drug Administration (FDA)) and Europe (European Medicines Agency (EMEA)) are the final arbiters of what constitutes a ‘safe’ drug name — that is a name that is not likely to cause confusion visually or verbally, which could lead to prescribing error. The regulatory hurdle is high, approximately 36 per cent of names submitted to FDA are not approved and 50 per cent of names submitted to EMEA are similarly turned down. This paper will help pharmaceutical marketers and brand managers prepare for the regulatory review process. The authors provide a summary of each Agency's process, describe the key issues of interest to regulatory bodies, and present a framework for approaching name validation research. They also discuss regulatory submission and the appeals process.