CBER promo untitled letter.

The following untitled letter was issued by the Center for Biologics Advertising and Promotional Labeling Branch (APBL). A copy of the letter is available to subscribers from RECORD-RETRIEVE for $7 plus retrieval.

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Berna Biotech, Berne, Switzerland, June 24 (APLB). CBER's Advertising and Promotional Labeling Branch reviewed a flyer for Vivotif [Typhoid Vaccine Live Oral Ty21a] and found it to be misleading in that it could lead patients and/or health care practitioners to believe that Vivotif is more effective than has been demonstrated. In unsubstantiated efficacy claims in the flyer, Berna stated that Vivotif, which is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi, is considered advantageous to Vivotif and Typhim Vi, an injectable typhoid vaccine manufactured by Aventis Pasteur. CBER said it is unaware of substantial evidence or substantial clinical experience demonstrating that Vivotif, because of its oral route of administration, is "particularly advantageous in providing optimal protection" against typhoid when compared to Typhim Vi. The referenced flyer also contained an incorrect proprietary name for Vivotif and was accompanied by an outdated version of the FDA-approved professional labeling (PI). FDA approved revised labeling for Vivotif on April 15, 2003, reflecting a change in the product's proprietary name. However, according to the untitled letter, the flyer was disseminated in September 2003 without the updated proprietary name. Further, the agency said that in a Jan. 6 telephone call between Berna Products, a distributor for Berna Biotech, and Maryann Gallagher of APLB, Berna admitted the flyer was disseminated even though the company knew it contained the incorrect proprietary name and outdated PI. F-B