Distracting factors in drug ads on TV: US FDA seeks feedback on study results

The US Food and Drug Administration has released the results of a study that was conducted in support of the agency's plans to establish standards for drug sponsors with regard to communicating a medicine's side effects clearly in TV advertisements^1-3.

The study relates to a proposed rule the FDA published in March 2010 to establish standards that would be considered in determining whether the major statement in television and radio ads relating to the side effects and contraindications of a prescription drug is presented in a clear, conspicuous, and neutral manner. It examined the impact of distraction on consumer understanding of risk and benefit information in TV ads.

The FDA is giving stakeholders until 27 February to submit feedback on aspects of the "distraction study" as it relates to the proposed standards on which a separate public consultation was held in June 2010.

Specifically, the study examined factors that might influence people's understanding of the risk information in the audio portion of the advertisement. It found that presenting risk information at the same time in text and in audio improved consumers' understanding of the risk information. The study did not find support for the idea that consumers' understanding of the risk information is influenced by the emotional tone of visual images or the consistency of the visual images with the risk information on the screen during the major statement.

References

1. Federal Register, 27 January 2012, 77(18), 4273-4274, www.gpo.gov/fdsys/pkg/FR-2012-01-27/pdf/2012-1672.pdf

2. Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements, posted online 27 January 2012, www.regulations.gov/#!documentDetail;D=FDA-2009-N-0582-0040

3. US FDA proposes standards to present drug risk info in TV and radio ads, Scrip Regulatory Affairs, 30 March 2010