FDA is directing GlaxoSmithKline and Novartis to revise direct-to-consumer ads for allergy products attempting to capitalize on the changes in the market following the OTC switch of Claritin .

In separate letters regarding GSK's nasal steroid Flonase and Novartis' ophthalmic antihistamine Zaditor , FDA objected to attempts by the companies to woo users of oral antihistamines.

In a ¹ June 19 letter, the Division of Drug Marketing, Advertising & Communications objected to GSK's ad campaign for Flonase highlighting the nasal steroid's formulary status versus other prescription antihistamines.

The print and radio ads highlight the changes in managed care coverage for oral nonsedating antihistamines following the Claritin switch, and stress that 99% of formularies cover Flonase (² Also see "Flonase DTC Ads Highlight Formulary Status Versus Antihistamines" - Pink Sheet, 17 March, 2003., p. 8).

FDA maintains that the ads imply that Flonase is safe and effective for the same range of indications as the oral antihistamines named in the ads (Pfizer's Zyrtec , Aventis' Allegra and Schering-Plough's Clarinex ).

"The clear implication of the radio and print ads is that Flonase can be substituted for (i.e., works as well as) the antihistamines for 'allergy relief,' and that Flonase is actually more useful than the other allergy medicines," FDA maintained.

"The ads misleadingly suggest that because Flonase is comparable or superior to the other 'allergy medicines,' the consumer need consider only the possible insurance co-payment cost in considering switching to Flonase." The agency notes that Flonase is not approved for use to treat any non-nasal allergy symptoms, while the oral antihistamines are.

FDA asks GSK to halt the ads; the company notes that the scheduled run already ended. The last print ads appeared May 11 and the last radio ad ran June 1.

The agency has been criticized for reacting too slowly to DTC ads, and the Flonase letter could be viewed as another example (³ Also see "DTC Ad Letter Review Cited By GAO; Chief Counsel’s Office Adds Two To Task" - Pink Sheet, 9 December, 2002., p. 3).

However, in another sense, the letter is quite timely, coming the day before the approval of Prilosec OTC .

GSK's attempt to capitalize on formulary changes in direct-to-consumer ads was a novel tactic, and the DDMAC letter suggested some guidelines should marketers of gastro-intestinal therapies consider similar approaches to changes in the proton pump inhibitor class following the Prilosec switch.

The Zaditor ad campaign is less overtly tied to the Claritin OTC switch, but the primary goal is the same: convincing existing antihistamine users to try a therapy more specifically targeted at one allergy symptom.

The ⁴ June 18 letter objects to a television ad for Zaditor focused on a golfer suffering from itchy, watery eyes. "If allergy pills aren't enough for your itchy eyes," a voiceover says, "try Zaditor - also called Z-drops."

FDA maintains that the ad, and similar messages on the Zaditor website, "contain a drug comparison that represents or suggests that Zaditor is more effective than other prescription drug products." The "wording, context and totality of these claims and presentations in your promotional campaign suggest Zaditor offers a superior way of treating eye allergy symptoms over other treatments," FDA maintains.

The agency also criticizes the presentation of the Zaditor risk information in the ads, specifically citing the use of a "fast-paced voiceover that impedes the ability of the consumer to understand, much less comprehend, this important information." FDA says the voiceover competes with a graphic on screen stating that the drug "relieves and prevents itchy eyes due to allergies."

"In fact, in this context, the voiceover information could be mistaken for a description of the patients who were successfully treated with Zaditor, rather than a description of the patients experiencing adverse events with Zaditor," FDA maintains. "The juxtaposition of these cognitively dissonant messages therefore further undermines the communication of risk information and minimizes the risk profile of the drug."

As was the case with Flonase, Novartis reports that the Zaditor campaign already ended before the letter was sent. The company described the commercial as part of its spring allergy campaign.

Flonase, Zaditor DTC Ads Cited By FDA; Both Allergy Campaigns Are Over

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