Overview of Direct-to-Consumer Prescription Medication Advertisements

Consumers are exposed to a plethora of healthcare advertisements on a regular basis. These advertisements are an important factor that drive purchasing decisions for prescription medications, which are essential resources that help prevent, treat, and cure diseases. The immense impact that direct-to-patient (DTC) prescription medication advertisements has on sales is reflected by their immense and growing yearly spend. In 2021, the biopharmaceutical industry spent $11.7bn on TV & radio advertisements alone. Although patients cannot directly make purchases of prescription medications themselves, they play a large role in determining which drugs are prescribed by their healthcare providers (HCP). Pharmaceutical and biotechnology companies thus carry a large responsibility to present facts as well as risk information in an accurate and understandable way.

Summary of the Clear, Conspicuous, and Neutral (CCN) Final Rule:

In November 2023, the Federal Food and Drug Administration (FDA) published finalized guidelines for direct-to-consumer (DTC) prescription drug advertisements (CCN Final Rule). These guidelines will specifically influence television and radio advertisements to ensure that the “major statement relating to side effects and contraindications (major statement) are presented in a clear, conspicuous, and neutral manner” (FDA). This final ruling, which officially comes into effect on November 20, 2024, establishes five key standards to ensure that the statements are presented in a way that is clear and understandable to the consumer, drawing upon the proposed standards established in the initial draft made in March 29, 2010.

Five Standards of the CCN Final Rule:

The following five standards provide guidance for pharmaceutical advertisers on how statements should be presented in a way that is “clear, conspicuous, and neutral”:

1. Proposed Standard #1 (final standard #1; § 202.1(e)(1)(ii)(A))): In order for language to be considered as “clear, conspicuous, and neutral” the statements describing the risks and contraindications should be easily readable and understandable by consumers. In other words, language should be simple and consumer-friendly. Companies should avoid using overly technical terms to describe risks except when stating diseases (i.e., hepatitis, tuberculosis) that have no replacement terms.
   
   

2. Proposed Standard #2 (final standard #2; § 202.1(e)(1)(ii)(B))): Advertisements must present audio that is understandable with regards to its volume, speed, as well as articulation.
   
   

3. Proposed Potential Standard #5 (final standard #3; § 202.1(e)(1)(ii)(C)): This rule establishes a dual modality requirement that the major statement be presented at the same time using both audio and text. Advertisers must ensure that (1) the text either displays the key terms or phrases from the corresponding audio or displays the exact transcript of the corresponding audio and (2) that the text is displayed for a sufficient duration as the corresponding audio to allow for consumers to be able to read it.
   
   

4. Proposed standard #3 (final standard #4; § 202.1(e)(1)(ii)(D)): Textual information within advertisements are presented in a manner that allows consumers to easily read it. To achieve this, advertisers might pay attention to achieving a contrast between the major statement text and background colors and images and also present it for a “sufficient duration” to be read by consumers.
   
   

5. Proposed standard #4 (final standard #5; § 202.1(e)(1)(ii)(E)): The major statement should avoid being presented alongside distracting elements (statements, text, images, sounds, or any combinations) that prevent consumers from understanding the risks and side effects of the medication. This standard intends to limit the amount visual or audio interference of the major statement.

Implications of CCN Final Rule on the Evolving Regulatory Landscape:

This final ruling highlights many existing regulations of the FD&C Act including 21 CFR 1.1.05(i), which requires a prominence of risk information in relation to side effects and contraindications to appear alongside advertisements. As pharmaceutical and prescription drug advertisements evolve to become more targeted, effectively communicating risk information about prescription drugs in a consistent and comprehensible way will only grow in importance.

The FDA’s final ruling also reflects the Government’s continued interest in ensuring that consumers possess accurate information when exposed to prescription drug advertisements. This longstanding interest only will increase with the emergence of novel technological platforms used to market therapeutics to consumers. For example, social media and other influencer marketing channels growing in popularity by marketers requires new regulatory enforcement and thus pose a new regulatory risk for many manufacturers. Prior to these new regulations being set in stone, advertisers will need to predict how the FD&C Act and the CCN Final for TV/radio ads will adjust to accommodate new platform specifications and nuances. Understanding these trends and building foresight to predict emerging regulations will be the difference that drives operational efficiency in commercial and marketing teams.