FDA Issues Final Guidance on Direct-to-Consumer Prescription Drug Advertisements

In late December, the FDA released a guidance document that provides clarity for small businesses marketing direct-to-consumer (DTC) drug products on television or radio.  The Q&A followed the FDA’s November 2023 Final Rule amending DTC advertising regulations for prescription drugs. 

Per existing FDA law, all DTC television and radio ads for prescription drug products are required to include a “major statement” providing information relating to the applicable drug’s major side effects and contraindications.  The Final Rule focused on the mandate that all major statements relating to drug side effects and contraindications be presented in a clear, conspicuous, and neutral manner.  The newly-released “Small Entity Compliance Guide” further clarifies how drug advertising may comply with these regulations.  This guidance has particular importance as the FDA requires that all “firms” (manufacturers, packers, and distributors of prescription drugs) must bring all covered DTC television and radio ads into compliance by no later than November 20, 2024.

While the Final Rule sets forth five general standards to help ensure that major statements are clear, conspicuous, and neutral, the FDA’s latest guidance explains how each standard may be met, as follows:

Standard 1: The first standard requires that a major statement be presented in consumer-friendly language that is readily understandable.  The guidance clarifies that this means major statements should not be in medical or technical jargon more familiar to health care providers, nor should it be so vague as to be subject to differing interpretations by the audience.  Per the FDA, the major statement should be readily comprehensible to the “ordinary consumer.” That said, the FDA recognizes that advertisements for prescription drugs are likely to include technical terms, so there is no specific reading level required.

Standard 2: The second standard requires that audio information presented for the major statement be at least as easy to comprehend as other audio information in the advertisement.  The guidance clarifies that this means firms should consider the volume, articulation, and pacing of the audio presentation to ensure that it can be as easily comprehended as other information in the advertisement.  This means that side effects and contraindications stated at a rushed or faster frequency than other audio in an advertisement might no longer be considered compliant. 

Standard 3:  The third standard requires that major statements in television advertising be presented in dual modality, i.e., concurrently both in audio and in text.  The text need not be a verbatim recitation of the audio, but must include, at a minimum, key phrases or terms from the corresponding audio.  The text must also be displayed for a sufficient duration to allow for easy reading.  The pacing of any audio statements must comply with Standard 2.

Standard 4:  The fourth standard requires that the major statement text must be placed “appropriately” on the screen with font size, style and contrast with the background that allow it to be easily read.  The FDA noted that, for example, increasing the amount of contrast between a font and background may improve readability, as may choosing styles of font that are more legible than others.

Standard 5: The fifth standard prohibits the ad from simultaneously including any overly distracting audio or visual elements that may interfere with comprehension of the major statement during its presentation.  The FDA clarified that while this standard does not outright prohibit use of creative elements during presentation of the major statement such as music, sound effects, or drawings, firms should examine the facts and circumstances presented by the advertisement to ensure compliance.

The guidance provides that firms with further questions about whether advertising is compliant may voluntarily request information from the FDA on proposed ads prior to their public dissemination.  While the FDA has committed to providing industry guidance, it has also committed to enforcing these regulations and has issued regular warning letters regarding DTC advertisements.  As the November 2024 compliance deadline looms, this guidance should prove a helpful reference for entities that must now assess and modify their drug advertising to avoid the risk of noncompliance.

If you have any questions about the DTC Final Rule or the FDA’s guidance document, please reach out to our Crowell & Moring team.