Abbott Labs has put its $70 million Humira ad account in review. The review follows a warning letter from the FDA about Humira's advertising, which the government called "misleading." The incumbent agency on the business is Harrison & Star, according to Adweek. The shop has had Humira since 2005, per Pharma Exec.
When drug agencies are fired after a high-profile screwup, the temptation is to figure out who to blame. Was it the agency that made the ad? Or the client, whose compliance department no doubt signed off on it before it ran? In this case, Abbott appears to have decided that H&S is at fault.
The ad in question is a doozy. It ran in a trade journal for the American Academy of Dermatology. See a closeup here. It featured a closeup of diseased body under the headline, "Now approved for moderate to severe plaque psoriasis."
That turns out not to be true. Humira is technically approved for "the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate."
With the FDA, the devil is in the details.
You'll notice that the safety information at the bottom of the ad is almost unreadable unless you magnify it by more than 100 percent. The FDA didn't like that at all:
... the presentation of the complete indication is written in white text on a pink background in an extremely small font size, rendering this information nearly illegible, while the broad, misleading statement of the indication and the accompanying graphic of the patient are presented very prominently and can be easily seen by viewers of the advertisement.Bottom line: Agencies pitching this account should assume that Abbott is now hypersensitive to FDA review, and thus you'll need a creative strategy that fits well within the regulatory lines.