FDA Announces Small Entity Compliance Guide on DTC Radio and Television Prescription Drug Advertisements

On December 27, 2023, the United States Food and Drug Administration (FDA) announced a new small entity compliance guide (SECG), “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers.” The SECG is intended to help small businesses understand and comply with the “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule,” which modified FDA regulations to reflect the requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that human prescription drug advertisements presented directly to consumers (DTC) in television or radio format and stating the name of the drug and its conditions of use present the major statement relating to side effects and contraindications (major statement) in a clear, conspicuous, and neutral manner and establishes standards to help ensure this requirement is met.

In the SECG, the FDA notes that the major statement is required in every DTC TV or radio ad that states the name of a drug and the conditions of its use and is a “selected presentation of the major side effects and contraindications” of an advertised prescription drug, not a listing of every risk.

Additionally, the SECG notes that a firm can know whether its major statement is presented in a clear, conspicuous, and neutral manner by considering certain standards that the FDA established. The standards established by the FDA are:

1. The major statement is presented in consumer-friendly language and readily understandable terminology.
2. The audio information for the major statement is as least as understandable as the audio information in the rest of the advertisement, particularly with respect to the volume, articulation, and pacing used.
3. The major statement is presented concurrently with audio and text for advertisements in television format.
4. For television format advertisements, for the text portion of the major statement, the size and style of the font, the contrast with the background, and the placement on the screen, should all allow for the information to be easily read.
5. During the presentation of the major statement, the advertisement should not include any audio or visual elements that are likely to interfere with comprehension of the major statements.

The SECG includes tips on how firms can comply with each of the five Standards outlined by the FDA, further explaining the Standards and what is meant by each one.

If firms have questions about whether a proposed radio or television advertisement is compliant with the Final Rule, they can voluntarily request comments from the FDA on a proposed advertisement before it is disseminated. If a comment is requested, the FDA will have reviewers in the Office of Prescription Drug Promotion (OPDP) and the Advertising and Promotional Labeling Branch (APLB) evaluate the materials and provide comments back to the requesting firms.

FDA is immediately implementing the guidance and inviting public comment. Firms have until November 20, 2024, to bring all DTC TV and radio ads into compliance with the Final Rule.