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Medicine manufacturing
5 July 20233 minute read

Key updates from FDA's latest guidance on presenting efficacy and risk data in DTC promotion

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presentations of efficacy and risk information in direct-to-consumer (DTC) promotional materials, FDA issued a draft guidance, titled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements,” providing recommendations on how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 While the final guidance is largely consistent with the 2018 draft guidance, there are certain changes that may influence how companies present quantitative efficacy and risk data.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.

The Final Guidance added a new section regarding the disclosure of quantitative efficacy or risk information from the control group in a clinical study. Specifically, FDA noted that “[w]hen a study includes a control group, firms that provide quantitative efficacy or risk information about a drug in DTC promotional communications should provide quantitative information from both the treatment group and the relevant control group.” To illustrate this point, FDA noted that if a controlled study showed that 68% of patients in the treatment arm experienced positive clinical outcomes, the promotional communication should include data from both the treatment and the control arms.

Another change is that FDA advises companies to prominently disclose the absolute probability measure and “in direct conjunction” with the relative frequency measure. For example, in a clinical trial, 1% of patients treated with Drug X had a stroke, compared to 2% of patients in the control group. This represents a 50% relative reduction in risk of stroke. To communicate this information in the DTC advertisement, the guidance recommends including the specific language in parentheses immediately after the claim: “In a clinical trial, Drug X reduced the risk of stroke by 50% (1% of patients treated with Drug X had a stroke, compared to 2% of patients in the control group).”

Finally, FDA cautions that the presentation of quantitative probability information about a particular risk should be done in a manner that does not minimize the severity of the risk. For example, if the FDA-approved labeling for Drug X states that 2% of clinical trial participants on Drug X experienced bleeding that required hospitalization, the promotional communications should not qualify the rate of the adverse event as “only 2% of patients experienced bleeding that required hospitalization.”

Besides the new recommendations, FDA deleted the statement that this guidance applies to all DTC promotional materials “regardless of the medium” and replaced that with a more nuanced statement: FDA recommends the companies should consider the amount of space or time available in determining whether and how to present quantitative efficacy or risk information in their DTC promotional communications.  This statement may reflect the agency’s view that not all DTC communication channels may be equally conducive to the full presentation of quantitative efficacy or risk information.  

If you would like more detailed information on this guidance or have other questions, please do not hesitate to contact the authors.