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Executive Summary

BECTON DICKINSON LACTINEX ORAL FEVER BLISTER STUDY should be designed to obtain objective measure to determine efficacy, FDA indicated in a recent letter to the firm. In an Aug. 17 "feedback" letter, FDA OTC Div. Director William Gilbertson, PharmD, told the firm that its proposed protocol for a study -- which called for patient selection and reporting of results by mail -- would be insufficient, by itself, to demonstrate efficacy of Lactobacillus acidophilus and Lactobacillus bulganicus in the treatment of fever blisters. The study could only be considered supportive, he said. The design of the study, Gilbertson noted, depends "on the subject's self-medication and personal estimation of effectiveness in order to simulate normal use of an OTC drug." Gilbertson told Becton Dickinson Corporate Medical Director Theodore Carski, MD, that FDA does not "believe that a study conducted without any clinical supervision could provide the objective and quantitative measurements necessary to demonstrate effectiveness." The agency included with its response to the protocol a copy of another firm's protocol which the agency said could provide a helpful example for designing a clinical study for the evaluation of fever blister drug product ingredients. FDA also faulted the Becton Dickinson protocol for allowing other drugs intended for the treatment of fever blisters to be used after the appearance of the fever blister. Gilbertson said that since the major effectiveness variable is relief of discomfort associated with fever blisters, "we do not believe the results of such a study would be reliable if other medications intended for the same purpose as the drug under study were permitted to be used during the study."

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