GSK Seeks To Halt Boehringer Promos That 'Denigrate' Effectiveness Of Ellipta, Diskus Inhalers
US FDA's wariness of taking enforcement action against Rx drug promotions may lead to more suits like GSK's. Complaint says healthcare providers are switching COPD patients to BI's Respimat inhaler in response to BI's marketing campaign.
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GlaxoSmithKline win shows value of going to court as US FDA is less likely to take action against comparative promotions. Court was swayed by GSK survey showing likely harm caused by ‘false and misleading statements not supported by scientific studies.’
US FDA’s 'consistent with labeling' guidance prompts more sponsors to consider comparative promotional claims, but any minimization of product safety issues still runs the risk of enforcement, legal experts say; Office of Prescription Drug Promotion’s research agenda on consumer understanding of Rx ad claims could result in an attempt to limit comparative claims.
Companies resolve litigation as competition in the psoriasis drug market intensifies; there are now 12 approved products in the US, with TNF-alpha inhibitors still dominating.