The FDA is moving ahead with a proposal to revise regulations concerning radio prescription drug advertising. The Office of Management and Budget is currently reviewing the final rule, which would change the focus on how a drug’s most crucial risks are presented in advertisements.
The proposed changes, which originated in 2010, include requirements that the language must be accessible to consumers. The proposal has seen periods of inactivity, with no official entries between 2012 and 2023, but the latest movement indicates a renewed interest in revising these regulations.
In the FDA abstract, it states, “Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. The rule would revise the regulation to reflect the statutory requirement that in DTC advertisements for human prescription drugs presented in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications of the advertised drug must be presented in a clear, conspicuous, and neutral manner. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.”
Proposed changes include that audio must be clear through proper volume, articulation, and pacing; text information must be easy to read with appropriate contrast and large font; and distractions that could detract from the essential statement must be minimized.
Post-COVID, pharmaceutical companies have been ramping up their radio advertising. Pharma and drugstore spending on network radio has increased by 59% since 2018. It remains to be seen how any regulatory changes would affect that spend.
