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CIBA-GEIGY REVISING HABITROL DIRECT-TO-CONSUMER ADS

Executive Summary

CIBA-GEIGY REVISING HABITROL DIRECT-TO-CONSUMER ADS to include specific statements about the prescription nicotine patch smoking cessation product that are spelled out in a "voluntary agreement" reached with 11 state attorneys general, Ciba-Geigy announced March 15. Under the agreement, Ciba will ensure that direct-to- consumer print ads for Habitrol will present "in a clear and conspicuous manner" eight statements about the smoking cessation product. The agreement does not affect TV or print reminder ads. Ciba-Geigy said that under the agreement it has 45 days to revise its ads, which are produced by Grey Advertising and will run nationwide. Under the agreement, Habitrol direct-to-consumer ads will include statements that Habitrol "won't work for everyone" and that it was proven effective "only when used as part of a comprehensive behavioral smoking cessation program." Also to be included are statements that Habitrol has not been studied in persons under 18; that the effect of Habitrol in pregnant women has not been studied; and that the product is a drug and available only by prescription. Similar statements are already contained in recent Habitrol consumer ads. However, the agreement with the 11 attorneys general spells out the exact wording to be used in such statements. "Almost all" of the statements required under the agreement are already included in direct-to-consumer ads for Habitrol, Ciba said, noting that "over the past year" it has gradually phased in revisions brought up during discussions with attorneys general from Arizona, California, Illinois, Iowa, Massachusetts, Minnesota, Missouri, New Mexico, New York, North Carolina and Texas who approached the company with "concerns" about Habitrol ads that ran in February 1992. FDA also has asked for some of the same statements requested by the attorneys general. In April 1992 the agency announced that patch marketers had agreed to include warnings against using the products for longer than the period stated in labeling, discouraging their use in pregnant or nursing smokers and stating the potential dangers of nicotine replacement therapy in patients with cardiovascular disease ("The Pink Sheet" May 4, 1992, T&G-3). The firm said March 15 that its "original advertisements had met all applicable federal guidelines." The agreement stipulates also that Ciba-Geigy may not state that "the most common side effect is skin irritation" in Habitrol ads because that statement "deceptively implies that skin irritation is the most serious health consequence from use of nicotine patches when such is not the case." The company must also discontinue its use of the slogan: "The patch that beats the pack" in print ads. Recently published Habitrol ads omit both statements. Nicoderm marketer Marion Merrell Dow said it is in discussions with approximately 11 attorneys general about ads for its nicotine patch. No conclusions have been reached, the company said. Warner- Lambert, which markets the Nicotrol patch said March 15 that it has not been approached by any attorneys general, but that "practically all" of the statements agreed to by Ciba-Geigy are already in Nicotrol direct-to-consumer advertising. Lederle, the ProStep marketer, said it had not been approached by any states, but that its direct-to-consumer ads are in compliance with all FDA regulations.
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