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FDA Retains Personal Touch In Monitoring Drug Promotions

 
• By Cathy Dombrowski

Based on a sales rep’s comments overheard at a pharmacist meeting, FDA warns Ortho-McNeil-Janssen about making unsubstantiated claims for pain killer Nucynta. The general pain relief claim granted the drug does not qualify it for use in the chronic pain condition discussed by the sales rep, FDA says.

An untitled letter to Ortho-McNeil-Janssen Pharmaceuticals Inc. serves as a reminder to drug companies that FDA continues to monitor company marketing efforts the old-fashioned way, by listening to sales reps’ statements at society meetings and exhibitions.

In this case, the date was Dec. 8, 2010, and the occasion was an American Society of Health-System Pharmacists meeting...

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