Correspondence: Beatrice Ellerin, rxmark 130 Fifth Avenue New York, NY 10011, USA. Tel: +1 212 739 9667; Fax: +1 212 739 9682; e-mail: bellerin@interbrandwood.com Web: www.interbrandwood.com

¹is the Managing Director of rxmark, the leading provider of global trademark assessment and brand research in the healthcare industry. She is responsible for all of rxmark's products, including the renowned 10/10^® Trademark Evaluation Model, which was recently updated to address the specific challenges faced by companies in the life sciences when conducting comprehensive regulatory due diligence. She holds a BA from Columbia University and an MBA from Harvard University.

²is the Director of Research at rxmark, where he manages the company's leading product, 10/10^® Trademark Evaluation Model. 10/10^® is a robust tool that incorporates multiple methodologies to help companies objectively evaluate brand names rather than rely on 'gut' or physician preference. To date, over 115 announced, FDA and/or EMEA-approved trademarks have been first 10/10^® Certified prior to agency submission, with many more awaiting introduction. He received a BS from Cornell University and is studying for an MBA at New York University.

Received 2 February 2007; Revised 2 February 2007.

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.