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Executive Summary

CIBA-GEIGY's ACTIGALL PROMOTIONAL VIDEOTAPE CRITICIZED BY FDA as "false and/or misleading" in that the tape suggests the gallstone-dissolving product is indicated for asymptomatic patients. In a July 5 regulatory letter to company President Richard Barth, FDA Drug Standards Office Director Peter Rheinstein, MD, maintained that the tape contains a "violative concept" in stating that "early treatment in asymptomatic patients reduces chances of progressing to emergency stage where surgery is necessary" (emphasis added by FDA). Rheinstein also said the tape is "violative" in claims that the drug (ursodiol) will enable patients to avoid gallbladder surgery. FDA said statements made in the tape include the following: "For your non-emergency gallstone patients so they can avoid surgery" "Early treatment with Actigall in symptomatic patients can prevent the development of complications and the emergency requirement of an operation" Physicians "can prescribe Actigall to treat non-emergency gallstones and help patients avoid surgery." The tape presents testimonial statements from physicians and patients. Other statements in the tape indicating that Actigall cures gallbladder disease, "can halt progression of the disease," or relieves gallstone pain and makes patients "symptom free" also constitute violations, according to the reg letter. The agency is asking the company to remove the video from all locations and issue a "Dear Doctor" letter, to be preauthorized by FDA, to all physicians who viewed the video. Actigall, which was approved in December 1987, is indicated for patients with radiolucent, noncalcified, gallbladder stones who are at high surgical risk or who refuse surgery. FDA called it a violation that the tape does not state Actigall's labeled indication. The reg letter cites a July 27, 1988 meeting between FDA and Ciba-Geigy, at which the agency emphasized that promotional materials for Actigall "must make clear that the drug is for patients who are not surgical candicates or who refuse surgery." In addition, FDA told the company that it objected to suggestions that the drug either provides symptomatic relief or reverses the disease process. Actigall promotional materials were the subject of a November 1989 letter from FDA to the company and a January 1990 meeting between the agency and Ciba-Geigy. "Your firm has been advised on numerous occasions, both in person and in writing, of the violative nature of certain promotional claims for Actigall, [and] Ciba-Geigy has been advised that these claims are violative without regard to the intended audience," the letter states. "Therefore, the violations presented in the 'Actigall Group Sell Video' constitute repeated, willful and flagrant violations of the FD&C Act."

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