Roche's television ad for the anti-obesity drug Xenical has been modified after the company received an Oct. 6 letter from FDA's Division of Drug Marketing, Advertising & Communications.

FDA cited Roche's original ad, which began running Oct. 4, for not "adequately" communicating Xenical's indication.

The agency cited the ad's inconsistent audio and visual messages. The audio presentation states Xenical is appropriate "if you're considerably overweight," while a visual presentation conveys a narrower indication, stating: "Xenical (orlistat) is recommended for adults who are at least 30 lbs. overweight depending on height." FDA's letter states that the competing messages do not "adequately convey the limitations to the population of patients for whom treatment with Xenical is indicated."

The audio and video presentations of the indication information are reversed in the revised ad.

The original Xenical ad also failed to adequately present risk information on the diet drug. "The risk information is presented in the audio portion of the advertisement concomitant with a visual presentation of the adequate provision components along with distracting sound effects. This presentation interferes with the audience's ability to comprehend and process the audio presentation disclosing Xenical's most important risks," FDA's ad division said.

In the modified ad, the volume has been lowered on the audio effects during the presentation of risk information.

A statement about one of the risks has also changed slightly. "You may experience gas or oil with discharge" in the first version has been changed to "You may experience gas with oily discharge."

Roche's Xenical DTC campaign launched Oct. 4 during prime-time television programming (¹ Also see "Roche Xenical DTC Ad Campaign Emphasizes 30% Fat Diet With Product" - Pink Sheet, 4 October, 1999.). While FDA had reviewed the ad storyboards prior to launch, the agency did not see the full video presentation.

Roche plans to run another Xenical ad titled "Food Lovers" starting at the end of the year. The second ad has also been modified and submitted to FDA following the letter, Roche said.

Roche Xenical TV Ad Modified Following FDA Letter

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