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Executive Summary

Direct-to-consumer prescription treatment messages that contain 800 numbers or write-in coupons are acceptable to FDA, as long as product-specific information is obtained by the consumer through a "multiple step process," FDA Division of Advertising and Labeling Acting Director Ken Feather said at a recent Food and Drug Law Institute meeting. "We do not object to the use of 800 numbers, but our policy has changed somewhat," the FDAer said, noting a previously approved Ciba-Geigy campaign which would not satisfy the agency now. Using television and print messages about menopause, the ongoing Ciba-Geigy campaign encourages consumers to call or write for more information. Those requests were filled directly with information on Estraderm estrogen patches. "You may recall that the Estraderm advertisement had a coupon and an 800 number and in response to either . . . you got a piece of literature about Estraderm itself. We would no longer accept that," Feather said. Feather explained FDA's new policy for educational ads as a "multiple-step process," with at least two levels of general information before a product is mentioned. In response to the 800 number, he explained, the consumer should get only information on menopause and concepts of hormonal therapy. "In that information, [there] could then be another write-in . . . address, 800 number, whatever, and in response to that, then the company could send out product specific information." Feather said: "We're asking that those ads be distanced from any product information as much as possible." Ciba-Geigy said that it is considering revising its advertising campaign for Estraderm in light of FDA's change in policy. In April, Ciba-Geigy launched its non-product specific television and print ads for Estraderm. The print ad, designed to make women aware of menopausal symptoms and encourage them to see their doctor, has been running in health and women's magazines. The companion television ad stopped running last week in Milwaukee, where it was aired for 20 weeks, the company said. The commercial aired in other parts of the U.S. during April and May only. After responding to the ads, consumers are sent a kit containing a brochure on menopause, information on estrogen replacement therapy, specific information on Estraderm including a patient package insert, and a placebo patch. Upjohn, with its educational consumer ads for Rogaine, successfully used the "multiple step process," FDA said. Upjohn has been running non-product specific commericials for Rogaine which display an 800 number for information on hair loss treatment options. Callers are then sent a certificate for $10, intended to encourage consultation with a doctor about treatments ("The Pink Sheet" May 22, T&G-7). At the FDLI meeting, Medical Advertising News Publisher Karl Engel identified Ciba's "use of both print and television to generate a response mechanism from consumers" as "probably the newest and biggest breakthrough that we've been able to identify in the area of direct-to-consumer advertising." Engel maintained that the use of a direct response mechanism is expanding "partly because it lets the company then send out very, very elaborate packages to the individual." Currently, he said, there are three other firms that are employing the use of a response mechanism: Lexis for its generic oral contraceptive, 3M Riker for its Minitran patch, and Fisons for Nasalcrom. With regard to direct-to-consumer advertising, Engel noted that "while the flood gates certainly have not opened, clearly more and more companies are moving into the area of direct-to-consumer promotion." Engel said that companies are turning more to consumer advertising to protect the market share of their branded products. He provided the example of Lakeside Pharmaceuticals' move away from educational ads for Nicorette to more aggressive product-specific ads.

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