Rx Drug Ads Should Not Characterize Probability Of Risk As Insignificant, FDA Emphasizes

Agency’s final guidance on presenting quantitative efficacy and risk information in direct-to-consumer advertisements includes an additional example, which specifies risk should not be characterized in a way that suggests it is not important.

Quantifying benefits and risks — FDA guidance advises drug manufacturers how to present quantitative efficacy and risk information in direct-to-consumer promotions • Source: Shutterstock

The US Food and Drug Administration’s final guidance on how to present quantitative information about a prescription drug’s efficacy and risks in promotional communications is virtually identical to the draft guidance issued in 2018. But it includes an additional example advising sponsors not to use the modifier “only” to avoid characterizing a risk as insignificant.

The FDA published the final guidance, “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements,”...