FDA regulates prescription drug advertising under the authority of the Federal Food, Drug, and Cosmetic Act (FDCA) and the implementing regulations. In 2018, after observing an increase in quantitative presentations of efficacy and risk information in direct-to-consumer (DTC) promotional materials, FDA issued a draft guidance, titled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements,” providing recommendations on how to ensure that DTC promotional materials present quantitative efficacy or risk information accurately and understandably.
On June 27, 2023, FDA finalized the guidance based on comments and recent research. While the final guidance is largely consistent with the 2018 draft guidance, there are certain changes that may influence how companies present quantitative efficacy and risk data.
In this alert, we have summarized those changes and key takeaways for companies to consider.