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CIBA-GEIGY's BUTAZOLIDIN/TANDEARIL REPORTING "IN FULL COMPLIANCE"

Executive Summary

CIBA-GEIGY's BUTAZOLIDIN/TANDEARIL REPORTING "IN FULL COMPLIANCE" with FDA regs, the firm contended in an April 3 letter to Acting Com. Novitch. Responding to recent allegations by the Health Research Group Director Sidney Wolfe, MD, that the company violated FD&C Act regs on reporting adverse reactions, the letter asserted: "Ciba-Geigy Corp. timely submitted to the agency copies of the retrospective compilation of Butazolidin [phenylbutazone] and Tandearil [oxyphenbutazone] adverse reactions prepared by Ciba-Geigy Ltd. (its parent corporation in Basle, Switzerland), in full compliance with all regulatory requirements." Maintaining that Wolfe's allegations "are unsubstantiated by either fact or law," Ciba-Geigy asserted it has consistently reported to FDA all adverse reaction reports received on the two drugs. "The Butazolidin compilation was filed with the agency as part of the Butazolidin annual report on July 5, 1983, the first reporting date to follow our receipt of the compilation," Ciba-Geigy stated. In addition, "the Tandearil compilation was filed. . . Nov. 30, 1983, some three months prior to the next annual report date for Tandearil," the company said, declaring: "Plainly, FDA's 12-month reporting deadline was met." Wolfe's charge that Ciba-Geigy failed to promptly report deaths from the two drugs was contained in a March 27 letter to Novitch in which HRG asked FDA to "promptly launch an investigation into what we believe are criminal violations of federal law in Ciba-Geigy's failure to promptly report hundreds of deaths in people using these drugs." An FDA "Talk Paper" issued March 27 in response to the HRG submission said the agency "will consider this matter but at present has no reason to believe that a violation was committed." Wolfe's March 27 letter also reiterated HRG's position that the drugs should be removed from the U.S. market and cited recent regulatory action regarding the drugs in Sweden, Israel and the U.K. Ciba-Geigy, however, main ained in its April 3 letter that "Dr. Wolfe presents no new scientific information that might justify banning" the drugs and again urged FDA to recommend that the imminent hazard petition be denied. Both HRG and Ciba-Geigy forwarded copies of their letters to Reps. Dingell (D-Mich.), Waxman (D-Calif.), and Weiss (D-N.Y.), with Ciba-Geigy providing copies of its letter to FDA's Drugs & Biologics Director Harry Meyer, MD, Chief Counsel Tom Scarlett and Drug Research & Review Director Robert Temple, MD, as well.

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