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.
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Untitled letter says advertisement could lead breast cancer patients to believe Kisqali has better overall survival and quality of life than was demonstrated. FDA also criticizes length of time to read claims in superimposed text and competing audio and visual presentations in the TV spot.
US FDA releases two letters on the same day citing two different kinds of advisements for two different kinds of products, but both with a classic problem: overstatement of efficacy. And while sending multiple letters at once can be seen as bid to draw attention to its enforcement action, the move also underscores just how few letters the agency has been sending lately.
Warning letter is first issued by US FDA’s Office of Prescription Drug Promotion in more than a year and only the seventh since March 2020, continuing a trend away from using the enforcement tool. AstraZeneca asked to distribute corrective communications about pamphlet’s efficacy claims.