Novartis' Unbranded Diovan Ads Draw FDA Scrutiny
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA has concerns that the unbranded ad, which is connected to a disease awareness program, too heavily references Novartis. The company has its own concerns that unbranded ads may not be effective in the anti-hypertensive market.
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Novartis has had two conference calls with FDA's Division of Drug Marketing, Advertising & Communications to discuss agency concerns about the company's unbranded direct-to-consumer Diovan (valsartan) campaign. "We have had some discussions with the FDA about the content of the copy," Pharmaceuticals CEO Thomas Ebeling said July 20 during an earnings call. Novartis said that FDA has raised concerns that the unbranded ads too heavily reference Diovan. In particular, Novartis said that FDA raised concerns that the ads are tied into Novartis' promotional program of offering a 30-day free supply of product, a money-back guarantee and reference to Novartis' website. FDA did not raise concerns with the professional detailing, Novartis said. "Our field force initiatives and our PR initiatives will certainly continue," Ebeling said. FDA's concerns come amidst the company's skepticism of the efficacy of an unbranded ad in the anti-hypertensive market. "It's a challenging category," Ebeling said. The company now appears to be left with little room to modify the campaign to create better patient response. Novartis said that website hits have greatly increased from about 1,000-4,000 hits per week before the campaign to about 100,000. However, the company noted that it has not yet seen much growth in total scripts due to the ads. Novartis believes that the campaign did not run long enough to create the awareness. "Unbranded campaigns usually need six months until you can really read them," Ebeling said. Novartis said that by the end of July or early August it expects to reach a decision on how to proceed with the campaign following its conversations with the agency. The company said that it is considering either modifying the ads, dropping them altogether, or voicing objections to FDA's concerns. "We had hoped the DTC would have an impact on the top line, so I'm slightly ambivalent on this one. I still hope that we can make DTC fly," Ebeling said. "If it doesn't work to the extent that we want it to work, then we have to correct our action," Ebeling said. The issues surrounding the campaign illustrate some of the difficulties that FDA faces in trying to encourage use of unbranded ads. Novartis launched a $25 mil. ad program integrated into its disease management program "Take Action for Healthy BP" in April (1 (Also see "Novartis Launching Hypertension Awareness Campaign With $25 Mil. Ad Spend" - Pink Sheet, 22 Apr, 2004.)). Disease management programs have been encouraged by HHS; Secretary Thompson attended Novartis' press conference announcing the launch of the program (2 (Also see "Novartis Makes Splash With Hypertension Disease Awareness Program" - Pink Sheet, 27 Apr, 2004.)). Any letter from FDA finding violations in the ads would essentially be criticizing a campaign that had tacit HHS support. Were FDA to cite the campaign, it would be the second letter about Diovan the agency has sent this year. Shortly before the unbranded campaign was announced, FDA sent a warning letter challenging a sales aide that suggests the angiotensin II receptor blocker is effective in diabetes (3 (Also see "Novartis Diovan Promotions Draw FDA Warning Letter For Diabetes Claims" - Pink Sheet, 29 Apr, 2004.)). FDA's concerns follow cautions described in a draft guidance released Feb. 4 as part of an agency effort to increase clarity of advertising oversight. Disease awareness ads that are similar, or shown in close proximity, to branded ads would be violative, FDA said (4 (Also see "Disease Awareness Ads Must Be Different, Distant From Branded Ads, FDA Says" - Pink Sheet, 4 Feb, 2004.)). Novartis said that FDA's intervention represents the agency's and industry's uncertainty as to how to apply the guidance. Novartis cautioned that excessive intervention could inhibit companies from launching the unbranded ads and disease awareness programs. Diovan performed well for the quarter, up 31% to $756 mil. - Lee Kalowski |