Advertising Law

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FDA Requests Pfizer to Pull Viagra "Wild Thing" Ads
Jeffrey S. Edelstein, Manatt, Phelps & Phillips, LLP, New York
E-mail: jedelstein@manatt.com

The Food and Drug Administration has asked Pfizer Inc. to pull two television commercials for its Viagra impotence drug because the "wild thing" ads fail to disclose the known risks associated with the drug and make unsubstantiated claims about the return of sexual desire.

In a November 10, 2004 letter to Pfizer, the FDA said the ads failed to mention Viagra’s major side effects and why some patients should not take Viagra. The drug, sildenafil citrate, can cause a dangerous lowering of blood pressure if it is taken with prescription drugs called nitrates. According to FDA-approved labeling, Viagra also has the potential for cardiac risk during sexual activity in patients with pre-existing heart disease. In addition, it can cause headaches, flushing, and transient abnormal vision. The FDA said that the ads additionally failed to mention the specific condition Viagra is intended for—erectile dysfunction.

The Television Commercials
At issue were a 30-second commercial and a 15-second version. The commercials show a middle-aged couple looking in the window of a lingerie store. A voice-over says, "Remember that guy who used to be called ‘wild thing’?" In the 30-second version, the voice-over then says, "The guy who wanted to spend the entire honeymoon indoors? Remember the one who couldn’t resist a little mischief? Yeah, that guy." Blue "horns" sprout from behind the man’s head. As the voice-over says, "He’s back," the horns become the "V" in Viagra. The man then takes his wife’s hand and leads her into the shop. The 15-second commercial is an abbreviated version of the 30-second commercial.

False Claims
The FDA said that Pfizer implied that the man seen in the commercials had returned 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 agency wrote."If you have data substantiating this claim, please submit them to FDA for review."

Information Relating to Side Effects Omitted
Under the FDA’s prescription drug advertising regulations, 21 CFR 202, advertising for prescription drugs must include "information in brief summary relating to side effects, contraindications, and effectiveness." "Reminder" advertisements, which call attention to the name of the drug but do not include indications for use or dosage recommendations, are exempt from these requirements. The FDA has issued "guidance" regarding direct-to-consumer broadcast advertisements, which permits streamlined disclosures in commercials but still requires disclosure of major side effects and contraindications.

Pfizer presumably considered the commercials to be reminder advertisements on the basis that they do not include the indications for use, and therefore Pfizer did not disclose Viagra’s indications, major side effects, and contraindications. Although the FDA letter does not explicitly discuss this, the FDA letter says that the ads "make representations about sexual activity in men who take Viagra." The letter also says that the ads "make clear that Viagra is intended for sex," and that, accordingly, the disclosures required by the prescription drug advertising regulations apply.

FDA Regulatory Action
The FDA said Pfizer should immediately cease using the offending ads and any similar promotions. It asked the company to respond by November 24, 2004 on its intent and plan to comply. According to TheStreet.com, by the date of the FDA letter, the ads had been airing for nearly three months. Pfizer said that it would pull the commercials, and that it had pulled the clips of the commercials from the Viagra Web site.

It is unclear whether the FDA’s regulatory action goes beyond the television commercials.The Viagra Web site, for example, reinforced the advertising campaign with a blue horned man under the headline "Get back to mischief."

A Precedent-Setting Decision?
Pfizer’s Viagra has been in an advertising battle with newer impotence competitors like Cialis, marketed by Eli Lilly & Co. and Icos Corp., and Levitra, marketed by GlaxoSmithKline and Bayer AG. According to press reports, Viagra is among Pfizer’s top ten best selling drugs, behind such products as Lipitor, Zoloft, and Celebrex. Viagra accounted for $1.87 billion in gross sales last year, including $1.1 billion in sales to American men.

According to Advertising Age (November 22, 2004), the FDA’s "bedeviling" letter to Pfizer "has many in the industry scratching their head. And wondering who is next. ‘I’m a little surprised, a little disappointed, but mostly I’m concerned," said one health-care agency president. "Viagra is so high-profile that this could be a precedent-setting decision by the FDA.’"

 

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