What are the general requirements for prescription drug advertisements directed toward consumers?
The same statute and regulations apply regardless of the audience targeted by a prescription drug advertisement. The Federal Food, Drug, and Cosmetic Act (the act) requires that all drug advertisements contain (among other things) information in brief summary relating to side effects, contraindications, and effectiveness. Because of this statutory wording, this requirement has become known as the brief summary. The current advertising regulations specify that this information disclosure needs to include all the risk information in a product’s approved labeling. Typically, print advertisements will include a reprinting of the risk-related sections of the product’s approved labeling (also called full prescribing information or the package insert). Sponsors, however, can write this risk information in language appropriate for the targeted audience; FDA encourages this approach. In addition to the specific disclosure requirements, advertisements cannot be false or misleading or omit materi
