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Executive Summary

Merck will re-emphasize its training for sales representatives at medical meetings regarding unsolicited requests for off-label information. According to a letter from the ad division to Merck July 19, a Merck sales rep asked a visitor to the company's booth at the American Society of Clinical Oncology meeting, "would you like to have off-label information sent to you about Cancidas?" and ran the visitor's name tag through a bar code reader. The company then mailed information about unapproved uses for the antifungal agent (capsofungin) under a cover letter stating that "this is in response to your request." Merck said it uses the bar code reader to expedite genuine requests for information, and the behavior described by FDA violates its policy. FDA describes similar behavior by a Schering-Plough Temodar (temozolomide) sales rep at the ASCO meeting in a June 28 letter to the company

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