Lamisil DRTV Ads Pulled after FDA Complaint

Novartis Pharmaceutical Corp. has interrupted an integrated advertising campaign for Lamisil, an anti-toenail fungus drug, after the U.S. Food and Drug Administration sent the Swiss firm a letter of complaint.

Harry Rohme, a spokesman for Novartis, acknowledged that the company had received a letter from the FDA, and that the company was working with the organization to bring the ads into compliance.

The television ads were taken off the air on Monday, Aug. 25, Rohme said.

According to published reports, the FDA claimed that the advertisements overstated Lamisil’s effectiveness and did not give enough emphasis to the drug’s side effects.

According to Rohme, the FDA was provided storyboards while the campaign was in production, as well as a videotape of the final ad before it aired.

"[The FDA’s] concerns are really from context, from my understanding," Rohme said. "They feel there are some implicit messages that they are not comfortable with. We will work with them to clarify that."

The direct response television ads, which were created by ad agency Deutsch, were the second wave of a $25 million campaign that has been running since April. The new ads, which debuted in mid-May, touted the two calls to action (877-NAILSRX and www.lamisil.com).