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FDA Is ‘Getting More Aggressive’ In Going After Drug Efficacy Claims Outside Label

 
• By Brenda Sandburg

Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.

FDA investigation
FDA is giving greater scrutiny to prescription drug promotions that overstate efficacy • Source: Shutterstock

Despite the paucity of enforcement letters objecting to prescription drug promotions, the US Food and Drug Administration has shown concern about one aspect of advertisements: efficacy claims that are inconsistent with labeling.

Torrey Cope, a partner at Sidley Austin, observed this trend at the Food and Drug Law Institute’s advertising and promotion conference on 3 November

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