Pharmaceutical clients often ask, “what if?” What if the primary name for which we’re submitting gets rejected by the FDA, or another global regulatory body, what is our recourse? What if there is a potential for a possible successful reconsideration? What if there isn’t enough time to submit an alternate name under IND when NDA is near? What if we stagger our submissions to the global bodies to enhance the possibility of a singular global name? What if stating a factual promotional claim within the name—especially when compared to recent successful precedents—isn’t approvable?
While these are all vital questions to successful name submissions that require answers, the most critical question that requires definitive direction is “if a backup name selection lacks internal consensus, what should we do?” The answer is to provide a backup name that would also prove just as successful if ultimately it was used as the product’s Brand name.
Now more than ever, the partnerships between a pharmaceutical manufacturer and a branding agency requires agency expertise. The amount of uncertainties that can arise from regulatory, creative, linguistics, trademark/URL distinctiveness, internal/external audience preferences, alignment with visual elements and global submissions must always be in focus. In addition, all these critical factors must ultimately be judged as to how many times they were repeated with multiple name candidates ready for submissions. To assure the discipline of naming does not cause undue angst with all the many other responsibilities consistent with Phase III and NDA submission activities, we always encourage clients be prepared. In the world of pharmaceutical Brand naming, Plan A is only as strong when there is a Plan B, Plan C, and perhaps additional plans equally as well thought out and agreed upon.
Much of brandsymbol’s pharmaceutical Brand naming business is constituted of developing backup names for a client facing upcoming critical deadlines with limited name options. The reasons for their concern are usually based on potential regulatory pushback, but they also include linguistics concerns and expanded internal team hesitance. Sound alike and look alike consistencies with other names, along with embedded promotional evaluations and acceptances by multiple global agencies make for high hurdles to overcome even with extreme diligence. To win in global pharmaceutical submissions, it’s more obvious than ever that one must always be “well named” with quality and quantity.