Executive Summary

Must be included in submissions of advertising and promotional labeling to FDA, Center for Drug Evaluation and Research Director Carl Peck, MD, emphasizes in a July 24 letter to about 750 NDA and ANDA holders and other interested parties. "It has come to our attention that VNRs issued by drug marketers are not being reported to FDA as part of their required submissions of advertising and promotional labeling," the letter says. VNRs must be submitted if they provide "information that makes any representation or suggestion related to the use of an identifiable drug product (whether or not the drug product or its sponsor is explicitly named," and if "the VNR is issued by or on behalf of the holder of the NDA or ANDA for the drug product," the letter says. Proposed VNRs should also be included with voluntary submissions of proposed materials for the launch of a new product, the letter adds.