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Novo's Victoza REMS Settlement Opens Another Legal Door For Off-Label Promotion Cases

 
• By Sue Sutter

US government alleged sales reps gave information to physicians to create a false or misleading impression that Victoza's boxed warning and REMS messages about medullary thyroid cancer were 'erroneous, irrelevant or unimportant.' Novo's $59m settlement includes resolution of whistleblower lawsuits alleging off-label marketing.

Gavel

Novo Nordisk AS' settlement of allegations that it downplayed and circumvented risk communication messages required under the Risk Evaluation and Mitigation Strategy for the diabetes drug Victoza (liraglutide) suggests another legal avenue for US government prosecution of behavior it views as related to off-label promotion.

On Sept. 5, the US Department of Justice (DoJ) and Novo Nordisk announced they had reached a $58

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• By Sue Sutter

The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.

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