This final rule implements a statutory requirement that in human prescription drug advertisements presented directly to consumers in television or radio format (DTC TV/radio ads), and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner. 

The benefits of this final rule stem from and include helping consumers notice, attend to, and understand the major statement in DTC TV/radio ads. The standards in the final rule help to ensure that DTC TV/radio ads convey a truthful and non-misleading net impression about the advertised drug and help ensure that consumers are better informed when they participate in healthcare decision making. We discuss the benefits qualitatively. 

The costs of this final rule include the cost to read and understand the rule, to revise a firm’s standard operating procedures, and to revise TV and radio ads during the transition period leading up to the compliance date. We also expect there to be modest ongoing costs for industry to review future DTC TV/radio ads to ensure that these advertisements comply with this final rule and an ongoing opportunity cost related to a potential change in the relative allocation of time within the ad between the presentation of the major statement and the presentation of other content.

Regulatory Impact Analysis

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) (PDF 557 KB)

Federal Register: 88 FR 80958
Publication Date: 11/21/2023 
Docket: FDA-2009-N-0582