Xarelto Ad’s Benefit Claims Need Renal Caveats, FDA Says
This article was originally published in The Pink Sheet Daily
Typography and graphics which highlight benefits but not risks makes a print ad for Xarelto to treat atrial fibrillation misleading, FDA tells Johnson & Johnson in an untitled letter.
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OPDP Director Tom Abrams cautions against reading into the “snapshot.”
FDA should not delay draft guidance on Internet and social media promotional activities while it studies how consumer understanding of a drug’s safety and efficacy is affected by the techniques used to present information on branded websites, according to comments on the proposed studies.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.