From Ian DeMeritt, Senior Medical Writer, Palio
“What’s in a name? That which we call a rose by any other name would smell as sweet.” – Romeo and Juliet (Act II, scene II)
What if that rose didn’t have a name, yet claimed that it smelled sweet?
Late last week, DDMAC issued several regulatory letters to pharmaceutical companies, bringing the total number of letters it has issued so far in 2010 to 22, already topping the 21 letters sent in 2008. Of interest was a letter addressed to GlaxoSmithKline for an unbranded, single-page ad (also shown above) placed in the Journal of Clinical Oncology last December.
The simple ad announced that a “New Treatment Option for Refractory Chronic Lymphocytic Leukemia (CLL)” was “NOW APPROVED.” A footnote clarified the treatment was for CLL “refractory to fludarabine and alemtuzumab,” and a disease-specific Web-site address (www.cllinformation.com) and the GSK logo were included on the bottom of the page. That’s it. No efficacy data were included, no overt promotional claims were made, and no fancy images of happy people walking along a beach were present.
Most importantly, however, no safety information was contained in the ad, despite its unbranded nature.
Even though the name of the treatment was not provided, DDMAC considered the ad misleading because “the characteristics of the product promoted in the ad can only describe Arzerra,“ the only drug recently approved by the FDA to treat refractory CLL. Because the promotional material could only apply to a single product, the ad was effectively considered a branded advertisement requiring full disclosure of safety and risk information.
In our line of work, the response to what we perceive as unfair feedback from a client’s regulatory team is often jokingly along the lines of “can’t we just turn this into an unbranded campaign?” thinking that by simply removing the branding elements, the regulatory requirements will also magically disappear.
However, one of the important lessons to be learned from this letter is that a pharmaceutical brand comprises more than just a logo and color pallete. The totality of the message being conveyed must also be considered a key branding element, especially in the eyes of the FDA.
This latest DDMAC letter provides a useful reminder that failing to call a rose by its name doesn’t make it any less of a rose.
Palio is a full-spectrum global pharmaceutical and consumer advertising, marketing, and communications agency that excels in brand creation and specializes in brand strategy, product launches, global marketing, and digital and integrated media.
Sally April 28, 2010
I remember seeing those ads, as they out around the time of ASH last year and many of us thought, “hmmm that’s aggresssive, I bet they get clobbered!”
The reason is the specific mention of the indication effectively turns it into a promotional piece with no fair balance.
In the past, DDMAC has left alone those that simply say (example from this specific case):
“Arzerra – Coming Soon”
with the GSK logo on the bottom but no mention of the indication.
Had they stuck to the tried and tested, albeit bland, approach it probably would have sailed by. And the brand awareness in a cancer journal would have improved to boot.
Thus the general rule that less is more is probably apt here.