FDA Issues Proposed Rule on Clear and Conspicuous Standard for DTC Advertisements
The Food and Drug Administration (FDA) is seeking comments on a proposed rule to amend the requirements for direct-to-consumer (DTC) advertisements as mandated under the Food and Drug Administration Amendments Act of 2007 (FDAAA). The change in regulations would require DTC television and broadcast advertisements of prescription drugs to place the “major statement” in a “clear, conspicuous and neutral manner.” Under the proposed regulation, FDA would use the following standards to determine whether the information meetings the clear, conspicuous and neutral requirement: (1) information is presented in language that is readily understandable by consumers; (2) audio information is understandable in terms of the volume, articulation, and pacing used; (3) textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and (4) the advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement. FDA is accepting comments on the proposed rule until June 28, 2010.
