By Lawson D. Thurston | August 2009
Global language and regulatory challenges abound when looking to create a name for a medicine
Ever wonder how a blockbuster pharmaceutical drug gets its name? It certainly isn’t drawn from a hat. In fact, the process of selecting a global brand name and identity for a new drug is quite complex and can involve testing in more than 40 languages and approval from global regulatory agencies that aren’t all on the same playing field.
James Dettore, founder, chairman & CEO of Brand Institute (BI), has been in the forefront of branding healthcare & consumer products since launching the company in 1993. With 14 offices around the globe, Dettore and his company were responsible for 77% of all Food & Drug Administration (FDA) approved names in 2008. BI was behind some 763 healthcare brands and 556 consumer brands to date.
According to Dettore, there are four barriers to entry in terms of globally branding a pharmaceutical drug.
“First, there is a trademark; second, making sure the name communicates effectively; and third, the nuances. You always have those situations where certain words or letters don’t translate or can’t be pronounced easily in different global markets,” he told CARIBBEAN BUSINESS. “The last barrier, which is really tough, is the different regulatory agencies, which aren’t always on the same playing field when evaluating brands around the world.”
BI’s vice president of creative development, Scott Piergrossi, said that over the past five years he has seen the challenges increase on all fronts.
“Each regulatory body from a global standpoint has its own approach to name approval and we have to find that happy medium that appeases all the regulatory agencies. In addition, the FDA has taken a much more conservative approach, making sure a name doesn’t ensure or imply anything that is too promotional or exaggerated by nature. The trademark landscape also is just as challenging these days.”
Although Piergrossi explained he has seen more companies trying to go it alone in naming their own products, usually they hit a wall when it comes to trademarks, can’t secure a global name and, ultimately, end up turning to BI for help.
“Probably the only thing that hasn’t changed, and has become more important, is the linguistic side of things. BI has always done our linguistic screens in 40-plus languages. We have just seen that companies are taking a closer look at those linguistic screens because nobody wants to be perceived as something silly or negative in any one country,” Piergrossi noted.
Front-row seat to global pharma industry
Its place in the forefront of the branding business gives BI a unique vantage point into the latest pharmaceutical trends in the global market.
According to Dettore, there are more than 3,700 pharmaceutical compounds in stage one, two and three in U.S. clinical trials. “There is a lot of action in the pipeline,” the BI chief said. Of the compounds in clinical trials, few make it to market. In 2008, the FDA approved just 85 products.
The BI executives noted pharma companies are getting additional life out of existing products through formulation changes (long-acting or sustained release), coming up with branded generic names and actually going a step further branding delivery-technology platforms and names.