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Executive Summary

BUSPAR, ALUPENT "FIRST CHOICE" ADVERTISING CLAIMS "require data from head-to-head comparative studies specifically designed to detect the claimed difference," FDA's Drug Advertising and Labeling Division told Bristol-Myers and Boehringer Ingelheim in recent letters. Objecting to Bristol-Myers' ads for Buspar as "the first choice for chronic anxiety" and Boehringer Ingelheim's ads for Alupent as "the first choice for asthma," the agency informed the companies that such claims are "false and misleading" because they are not supported by comparative data. After a number of letters and/or meetings between the firms and FDA, both Bristol-Myers and Boehringer Ingelheim agreed to revise their promotional pieces to delete the "first choice" claims. In Aug. 25 correspondence with Bristol-Myers regarding the ads, FDA noted that "the industry is increasingly employing drug of choice claims and we consider this to be a growing problem that must be responded to." FDA also noted that it is "planning to arrange a workshop where our position regarding drug of choice claims will be reiterated and discussed." The topic of drug choice claims will also be addressed by the Advertising Division's assistant director, David Banks, at a Sept. 27 session of the Regulatory Affairs Professionals Society meeting in Alexandria, Virginia. Banks wrote the series of letters to Bristol-Myers and Boehringer Ingelheim. Bristol-Myers has been using the phrase "first choice for chronic anxiety" since Buspar's launch in 1986. Some of the ads containing the phrase have been precleared by FDA. Responding to the preclearance issue, FDA noted that "our not objecting to a claim does not necessarily constitute specific approval of that claim, and our position regarding drug of choice claims has been well known for some time." In addition, FDA said, "it is well known throughout the industry and is continually communicated in our correspondence that we reserve the right to change our position in regard to any promotional claim." In a memo of a Sept. 19 meeting with Bristol-Myers, the agency indicated that phrases such as "a good place to start" would be an acceptable alternative to "first choice" statements. "We discussed 'drug of choice' and 'near-drug of choice' claims at length, and suggested that the firm use alternative wording, such as 'a good place to start,'" the memo states. However the meeting memo notes that Bristol-Myers was "also advised that qualifying terms such as 'logical' result in claims still considered claims of overall superiority [and] such claims must be supported by comparison of overall risks/benefit." In response to FDA's letter on Alupent ads, Boehringer Ingelheim said "the slogan 'first choice for asthma' was never intended to mean, imply, or convey any comparative message." The statement, the firm said, "is a marketing phrase intended to catch the physician's attention and then reaffirm Alupent's use as a first line therapeutic agent in asthma." Boehringer Ingelheim defended its use of the "first choice" claim, asserting that such catch phrases are "common practice" within the pharmaceutical industry. The firm cited promotional first choice claims for Buspar, Serono's Serophene, SmithKline's Tagamet, Merck's Noroxin and Syntex' Lidex. The firm also noted similar claims, such as Dermik's promotion for Psorcon as "the logical choice in high potency steroid treatment" and Riker's promotion of Tambocor as "the one to start with." FDA, in a memo of a subsequent teleconference to discuss Boehringer Ingelheim's response, noted that "other firms are employing similar claims, but those claims are in many cases referenced to sales figures or other factors rather than product selection." FDA has "acted against many of the other objectionable claims, and [intends] to act against others," the agency added.

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