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Executive Summary

PRAXIS HIBTITER HISTORY OF MISLEADING PROMOTIONAL ACTIVITIES CITED by FDA in a March 4 regulatory letter. Following a review of Praxis' promotional activities for its Haemophilus influenzae b conjugate vaccine, the agency concluded that "Praxis engaged in a series of events designed to promote and commercialize the product HibTITER as safe and effective for purposes for which it was being investigated." The violations occurred both prior to approval of the vaccine in December 1988 and postapproval, the reg letter notes. The Center for Biologics Evaluation and Research sent Praxis four letters, in 1988 and 1989, warning the company that its HibTITER promotions were inappropriate. FDA cited the issuance of a news release in March 1988 which represented HibTITER "to be of higher purity and quality characteristics than other manufacturers' vaccines" and suggested that the product was "soon to be approved by FDA." In April and May of 1988, the reg letter states, the company distributed professional materials and placed an ad in the journal Contemporary Pediatrics that made claims about purity that were "not supported by data available to FDA" and claims that HibTITER is "a more effective vaccine than a competitive vaccine because it elicits a stronger immunogenic response." Praxis also sent pediatricians a brochure entitled "Vaccine Update" suggesting the superiority of HibTITER to other Hib conjugate vaccines, the agency noted. Following approval of the product for use in children 18 months and older, FDA asserted that on at least five occasions Praxis was in violation of the FD&C Act. FDA cited the December 1988 distribution of a draft scientific article authored by five Praxis scientists that highlighted the use of the vaccine in "very young infants," while making "unsupported comparative claims against an approved product." The company did not receive approval for use in infants down to two months old until October 1990. In a letter to physicians in February 1989, Praxis called HibTITER "the most advanced conjugated vaccine," noting that the product's "lack of 'chemical linkers'" reduces the number of allergic reactions. FDA said that "there is no evidence" to support such a claim. Around the same time, the reg letter states, Praxis salespeople were suggesting in "written materials and oral statements" that the conjugate vaccine could be used in infants. "The representation and suggestion that HibTITER could be used, and would provide protection, in infants under the age of 18 months was not an approved indication and the labeling did not contain adequate directions for use," FDA maintained. In the reg letter, FDA cited Lederle Labs, Praxis' parent since June 1989, once for distributing materials that made "unsupported" efficacy claims over a competing vaccine based on the assertion that HibTITER elicits a stronger immunogenic response. Lederle explained that although it technically owned Praxis at the time the materials were distributed, the two companies' marketing and sales organizations were not fully integrated until November 1989, and the promotional materials that appeared in March 1990 were probably planned prior to their distribution. Lederle-Praxis formally answered FDA's assertions in a March 18 letter from Regulatory Affairs Senior Director David McClintock, PhD, to CBER Acting Director Gerald Quinnan. In the letter, the company indicated that most of the violations occurred prior to the merging of the Lederle and Praxis organizations. However, Lederle defends Praxis in the letter, noting that the company had taken corrective actions in response to each of FDA's complaints. "Each action was believed to bring Praxis into full compliance with regard to the situation cited by the Center," the letter states. McClintock told Quinnan that the "Praxis sales and marketing groups have been disbanded and now the sales of HibTITER are through the Lederle Laboratories' ethical sales force," with marketing functions "now handled by the Lederle Biologicals' Marketing group." McClintock said that "all materials are reviewed and approved by the medical, legal and regulatory groups." And as requested by FDA, all promotional materials are supplied to and approved by CBER "prior to use." Lederle-Praxis' response is under review, according to FDA. The intent of the reg letter, the agency said, was to make Praxis aware that its past promotional activities were unacceptable and should not occur in the future. "If recurrence of the same or similar practices for any biological/drug distributed by [Lederle- Praxis] is identified, we will consider this letter to have served as prior warning and notice of our intent to pursue appropriate regulatory action," FDA warned.

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