The Latest Guidance From FDA on DTC Advertising: Is Greater Enforcement Next?

Below is an overview of the latest FDA Guidance on DTC Advertising. This guidance complements a final rule issued by the FDA in November 2023 that set out the five standards to be followed by pharmaceutical manufacturers for delivering the major statement required in DTC ads in a “clear, conspicuous, and neutral manner.”

Howard Dorfman, Founder of H.L. Dorfman Pharmaceutical Consulting, provides his perspective as an expert in FDA regulatory law, fraud and abuse, compliance programs, and risk management procedures. Howard is also the author of the Practicing Law Institute’s Answer Book on Pharmaceutical Compliance and Enforcement, and a Visiting Distinguished Professor at Seton Hall Law School. Feel free to reach out to him with any questions at hldorfman@gmail.com.

In late December 2023, the US Food and Drug Administration (FDA) published a final guidance detailing five standards drug manufacturers should follow to ensure direct-to-consumer (DTC) radio and television advertisements are adhering to FDA regulatory requirements.

The first standard requires the manufacturer's major statement to be presented in consumer-friendly language and readily understandable terminology. The FDA indicated that manufacturers must avoid language in the presentation of the major statement that is highly technical in nature, which relies on complex medical terminology, or so vague as to allow for various interpretations. While the FDA indicates that the language used does not have to meet a particular grade level for comprehension, (a change in policy), nevertheless the information would need to be understandable to the ordinary consumer.

The guidance also addressed various other elements associated with broadcast ads. For example, the FDA requested manufacturers take into consideration the volume level of the advertisements, articulation of the major statement, as well as overall pacing, The FDA considers these essential elements for comprehension by consumers. In a similar vein, FDA indicated that any accompanying text should be displayed long enough to allow consumers to read the material easily and remain on screen throughout the corresponding audio. The guidance also requires that the advertising text conform to certain style, font, screen contrast and screen placement requirements to facilitate understanding.

The final standard tracks a long-standing concern of FDA to avoid any distractions that would impede understanding of the major statement and recommends manufacturers utilize any elements that would facilitate comprehension of any safety information that is part of the ad.

It is likely that the final guidance will generate a desire for manufacturers to engage with FDA earlier in the process to avoid regulatory action addressing any shortcomings in an ad campaign once launched. This blog raises the question on whether FDA oversight will continue to increase. The issuance of this newest guidance and prior warning letters indicate that OPDP remains vigilant in its review of promotional materials.