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Comparative Rx Economic Claims Without Head-to-Head Trials Risky – J&J’s Jimenez

 
• By Cathy Kelly

Johnson & Johnson Associate General Counsel Freddy Jimenez acknowledges a continued reluctance among biopharmaceutical companies to make health care economic claims in the absence of further guidance from FDA.

Drug manufacturers should proceed with caution when considering disseminating comparative health care economic claims that are based on observational data or other studies that are not randomized controlled head-to-head comparisons, Johnson & Johnson Associate General Counsel Freddy Jimenez commented April 21 at the Food and Drug Law Institute Annual Conference in Washington, D.C.

“I would say… the [traffic] light is yellow” on disseminating health economic data, Jimenez said, given that FDA has yet...

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• By Bridget Silverman

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• By Michael McCaughan

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• By Sarah Karlin-Smith

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