Regulatory Focus™ > News Articles > FDA Releases Study on Major Statements in DTC Advertising, Reopens Comment Period on Proposed DTC Re

FDA Releases Study on Major Statements in DTC Advertising, Reopens Comment Period on Proposed DTC Regulation

Posted 27 January 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released the results of a new study on 27 January that explores the impact of distraction on a consumer's understanding of important information in direct-to-consumer (DTC) television advertising.

The study, Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements, was conducted in response to a proposed rule FDA published in March of 2010.

That proposed rule, Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner, sought to amend regulations concerning DTC advertisements for prescription drug products such that all DTC advertising would have to present their major statements-statements relating to the safety, side effects and contraindications of a product-in a "clear, conspicuous and neutral manner."

The proposed rule would lay out clear guidelines for what the agency would consider to be "clear", "conspicuous" and "neutral" major statements, and what constituted a "distraction".

The new study supporting this proposed rule found that "presenting risk information at the same time in text and in audio improves consumers' understanding of the risk information."

Further, "[t]he results of the Distraction Study did not find support for the idea that consumers' understanding of the risk information is influenced by the emotional (affective) tone of visual images or the consistency of the visual images with the risk information on the screen during the major statement."

With the release of this study, the comment period on that proposed rule is being re-opened until 27 February, 2012.



Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe