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CIBA-GEIGY DROPS ACTIGALL DIRECT-TO-CONSUMER ADS AFTER "PROACTIVE" MEETINGS WITH FDA; VOLTAREN PROMOS UNDER INVESTIGATION BY JUSTICE DEPARTMENT

Executive Summary

Ciba-Geigy has discontinued its direct-to-consumer advertising campaign for the gallstone treatment Actigall (ursodiol) as one of a series of changes in its advertising and promotions policy adopted after several meetings with FDA over a four-month period earlier this year. Ciba-Geigy began the $ 5 mil. campaign on Jan. 15 with print ads asking patients with gallstones: "Gallbladder surgery. What if you can't or won't have it?" ("The Pink Sheet" Jan. 21, T&G-10). The campaign was among issues drawing "specific FDA criticisms" during meetings, Ciba-Geigy said Sept. 16, so the company voluntarily halted the campaign in June. "This action is being taken in light of agency concerns that this campaign insufficiently informs consumers that surgery is the preferred treatment for most patients with gallstones," Ciba-Geigy said. At a February press briefing, FDA Commissioner Kessler had criticized the ads for not making clear that there were newer, less obtrusive forms of surgery that patients should consider ("The Pink Sheet" March 4, p. 3). According to the company, the announcement of the new advertising policies was not related to a grand jury subpoena received Sept. 3 from the New Jersey U.S. Attorney's Office in Newark asking the company to produce all documents pertaining to the promotion of the nonsteroidal anti-inflammatory drug Voltaren (diclofenac). Ciba-Geigy would not elaborate on the nature of the grand jury investigation. The most prominent feature of the drug's promotion, however, was the use of baseball great Mickey Mantle as a paid spokesperson for Voltaren after the drug's approval in late July 1988. The company said it "intends to cooperate fully with the grand jury request." The grand jury investigation is not the result of an FDA referral to the Justice Department, the agency said. Ciba-Geigy stressed in a Sept. 16 press release that the advertising meetings held between March and June with FDA's Division of Drug Marketing, Advertising and Communications were held at the company's request to discuss FDA's "specific objections" to some of Ciba-Geigy's past promotional practices as well as "concerns FDA has articulated regarding general marketing practices in the pharmaceutical industry." Ciba-Geigy "decided to proactively initiate a dialogue with the FDA" about its advertising practices, the company said. As a result of the meetings, Ciba-Geigy "decided to immediately discontinue certain promotional programs and . . . to significantly strengthen a number of internal practices and procedures with an eye towards eliminating areas of potential dispute with FDA in the future," the company said. The meetings were not held under threat of any enforcement action, FDA said. The agency noted that, while it is supportive of Ciba-Geigy's actions, the company's statement is not any sort of "agreement" with FDA and does not preclude any future agency enforcement activity. Ciba-Geigy's unilateral meetings with the ad division are reportedly unusual despite the agency's widely publicized interest in drug advertising enforcement and its attempt to solicit comment from the outside. The Pharmaceutical Manufacturers Association recently began a series of more general meetings with FDA on the topic of promotions ("The Pink Sheet" Aug. 26, p. 3). Ciba-Geigy's decision to initiate discussions with FDA could benefit the company in two ways: (1) it may clear the air on some of the company's previous aggressive efforts at market stimulation; and (2) it allows Ciba to play an active role in developing the standard for non-violative promotional practices. The Mickey Mantle Voltaren promotion was criticized by public television's Frontline and has since become a favorite example among critics of industry promotional practices. Senate Labor & Human Resources Committee Chairman Kennedy (D-Mass.) questioned Ciba-Geigy about the promotion following his Dec. 11-12 hearings on pharmaceutical marketing ("The Pink Sheet" Jan. 7, T&G-3). Commissioner Kessler has cited the promotion on several occasions. Ciba-Geigy's promotions of Actigall also drew criticism from Sen. Kennedy and FDA. The company received a regulatory letter on July 5, 1990 for a promotional video for Actigall that suggested that the drug could treat asymptomatic patients and help patients avoid surgery ("The Pink Sheet" July 9, 1990, T&G-8). Kennedy questioned Ciba-Geigy about the video after the December hearings as well. In addition to halting the Actigall ads, Ciba-Geigy said it also will no longer use celebrities to promote its prescription drug products. In addition to Mickey Mantle, Ciba-Geigy has used actress Shirley Jones to promote its estrogen replacement transdermal patch Estraderm. The company noted that it has not used celebrity endorsements at all in 1991 but is still running direct-to- consumer ads for its Estraderm transdermal estrogen product. Ciba-Geigy will also "redouble its efforts to ensure that comparative superiority claims will be based upon data from adequate and well-controlled clinical trials and will be consistent with the body of available clinical data." FDA reportedly has expressed concern several times in the past year about comparative claims used in promoting Voltaren. In addition to the changes undertaken in response to specific criticism from the agency, Ciba-Geigy has made a number of internal changes in response to FDA's industry-wide promotional concerns. The company has "tightened" its internal review procedures to ensure that all promotional materials "are subject to clearance by the company's medical and legal reviewers." In addition, Ciba- Geigy said it will implement a "new procedure so that currently- in-use promotional literature is internally re-reviewed periodically in light of new medical information and FDA regulatory guidance." Ciba-Geigy has also taken steps to address two "hot" areas of FDA promotional concern: symposia and video news releases. To ensure that symposia "provide balanced medical education," Ciba- Geigy will rely on peer review and continuing medical education accreditation. The company noted that 95% of its symposia are accredited. Furthermore, "steps will be taken to assure that company- sponsored symposia will be nonpromotional in tone and will objectively discuss alternative therapies." The company did not elaborate on specific "steps" it would be taking. Commissioner Kessler has identified drug promotion in the guise of scientific exchange as a prime target for enforcement action, while industry and the medical community have been struggling with appropriate methods to ensure the objectivity of industry-sponsored symposia ("The Pink Sheet" Sept. 16, p. 3). For video news releases (VNRs), Ciba-Geigy said it will take steps to make it "more difficult for the media to 'edit out' the balance content" which it "routinely incorporates" in its VNRs. The company said that it would place the "balance content" sooner in the story and make it more a part of the fabric of the VNR. Ciba-Geigy will also work to make target audiences of all its promotions aware of its role in the promotion. Finally, Ciba-Geigy has addressed the area of marketing research. The company "does not engage in activities which it holds out as market research in the absence of substantive market research goals," Ciba-Geigy stated Sept. 16. The company claims that it discloses the promotional intent to participating physicians and avoids reference to unapproved uses or unfounded comparisons.

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