Pfizer has agreed to pull its DTC television ads for Viagra after the
FDA’s Division of Drug Marketing, Advertising and Communications
(DDMAC) issued the company a warning letter stating the commercials misbrand the drug in violation of the Federal Food, Drug and Cosmetic Act.
The letter, dated Nov. 10, states the ads, created by Interpublic Group’s McCann Erickson, omit the indication for the drug and imply taking Viagra can provide a return to a previous level of sexual desire.
“The TV ads claim that Viagra will provide a return to a previous level of sexual desire and activity. They refer to the sexually active past of the man (e.g. “Remember that guy who used to be called ‘Wild Thing?) and then declare “He’s back,” implying that, by taking Viagra, he has returned to that previous level of sexual desire and activity,” wrote Christine Hemler Smith, consumer promotion analyst and regulatory review officer for DDMAC.”FDA is not aware of substantial evidence or substantial clinical experience demonstrating this benefit for patients who take Viagra.”