June 27, 2005

The FDA's advertising division has issued an untitled letter to Eli Lilly charging a television advertisement for the firm's attention-deficit/hyperactivity disorder treatment Strattera fails to communicate the drug's indication and minimizes the product's risks.

The letter from the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) focuses on a 60-second television ad titled "Video Game," which promotes Strattera (atomoxetine HCl) capsules as a treatment for attention-deficit disorder in adults. The ad, which presents a person in a variety of situations as seen through a video game, is misleading because it doesn't adequately communicate information about Strattera's indication, DDMAC's letter states.

Although Lilly did include information about Strattera's indication in the ad, the information was presented in a way that was misleading, according to the untitled letter, which was published on the FDA's website earlier this month. "The TV ad fails to clearly communicate the indication for Strattera because of competing visuals, graphics and music that are presented at the same time as the information ... relating to the indication," the letter states.

DDMAC took particular exception with the ad's video game-like presentation, which included scrolling text, flashing graphics and "eerie" music. "All of these competing graphics distract from and overcome the important contextual information to such an extent the presentation interferes with the viewer's ability to process the information in the ad relating to the indication," the letter states.

DDMAC requests in its letter that Lilly immediately stop airing the ad, but, according to a Lilly spokeswoman, the company had already shelved the advertisement before it received the letter. The company doesn't believe the ad was misleading, the spokeswoman added.