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

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...

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