FDA Asks Pfizer To Withdraw ‘Wild Thing’ Ads for Viagra
FDA has sent a letter to Pfizer that asks the company to withdraw "Wild Thing" television advertisements for Viagra because the ads fail to disclose the condition the medication treats -- erectile dysfunction -- and potential side effects, the Wall Street Journal reports. The ads, which feature a middle-aged man "gazing at black bra, panties and negligee in store window," make "representations about sexual activity in men who take Viagra," the FDA letter said (Hensley/Vranica, Wall Street Journal, 11/16). In the ads, the narrator states: "Remember that guy who used to be called 'Wild Thing'? The guy who wanted to spend the entire honeymoon indoors? Remember the one who couldn't resist a little mischief? Yeah, that guy. He's back." At that point, the "ends of the blue V from the Viagra brand logo" rise behind the head of the man "like a pair of devil horns," the New York Times reports. The image also has appeared in print ads in newspapers and magazines (Elliott, New York Times, 11/16).
FDA said that the ads "were so suggestive they were tantamount to touting the drug's effectiveness, thereby requiring a full description of the evidence for the claim and the possible downside," the Journal reports (Wall Street Journal, 11/16). The FDA letter, which appeared on the agency Web site, also states that the ads "claim that Viagra will provide a return to a previous level of sexual desire and activity. FDA is not aware of substantial evidence or substantial clinical experience demonstrating this benefit for patients who take Viagra." The FDA letter asks Pfizer to withdraw all "promotional materials" similar to the TV ads but did not include specifics. Pfizer is required to draft a formal response to the FDA letter by Nov. 24 (AP/Houston Chronicle, 11/16). A Pfizer spokesperson said that the company will comply with the FDA letter, although the ads might continue to air for several days. The $110 million "Wild Thing" ad campaign was the first produced for Viagra by McCann Erickson Worldwide, part of the Interpublic Group of companies. Pfizer in 2000 received a similar FDA letter related to a Valentine's Day Viagra ad (Wall Street Journal, 11/16).
FDA spokesperson Brad Stone said that the "Wild Thing" ad campaign "crossed the threshold into making what could be considered a drug claim." Pfizer spokesperson Daniel Watts said that the company would "end the ads in this form" but was "not sure whether anything will replace them right away" (New York Times, 11/16). According to the Journal, the FDA letter "underscores the increasing controversy around direct-to-consumer advertising for prescription drugs, particularly the vague so-called reminder ads." Mel Sokotoh, executive vice president at Foote Cone & Belding, part of the Interpublic Group, said, "The FDA's original purpose (in allowing direct-to-consumer ads) was to create a more informed dialogue" between patients and physicians. Sokotoh added that pharmaceutical companies have "to be more careful about selling techniques that could be perceived as opportunistic" (Wall Street Journal, 11/16).
Sidney Wolfe of Public Citizen said that FDA enforcement against such DTC prescription drug ads has decreased from 157 actions in 1998 to 23 actions in 2003, adding, "If you are the industry, you cannot help but notice the FDA has largely stopped enforcing the laws and regulations on drug advertising. Therefore, you're almost encouraged to run misleading ads like this. By the time the FDA catches up with this kind of ad, it's likely millions of people, or more, have seen the ad" (AP/Houston Chronicle, 11/16). FDA acting Commissioner Lester Crawford said that the agency plans to increase regulation of DTC prescription drug ads, adding, "We've had enough of some of these things" (Dooley/Ostrow, Bloomberg/Chicago Sun-Times, 11/16).