On April 28, 2011, The Food and Drug Administration (FDA) announced plans to study online consumer advertising for prescription drugs in order to resolve a number of questions surrounding how to achieve ‘fair balance’ in online Direct-to-Consumer (DTC) promotion.
Pharmaceutical products are launched and marketed in a number of new ways that did not exist a short time ago. Increasingly, prescription products are promoted to consumers online in such formats as banner ads, websites, and videos. The interactive nature of the Internet allows for features not possible with traditional media (i.e., print, radio, and television), such as scrolling information, pop up windows, linking to more information, and embedding videos.
FDA regulations require that prescription drug advertisements include a fair balance of information about the benefits and risks of advertised products, both in terms of the content and presentation of the information. All prescription drug ads that make claims about a product must, therefore, also include risk information in a balanced manner.
This recently announced project is designed to test different ways of presenting prescription drug risk and benefit information on branded drug websites. This research is relevant to current policy questions and debate and will complement qualitative research they plan to conduct on issues surrounding social media. The original regulations that presently determine FDA’s position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast, and the primary audience was health care professionals. This dynamic is shifting, and evidence is needed to support guidance development.
According to the notice, the research will be conducted in three concurrent studies. The first three studies are experimental and the fourth is qualitative.
The first study, with 4,000 participants, will look at the format for example, whether the risk info is presented in a paragraph or as a bulleted list and visibility (whether risk info can be seen without scrolling down) of risk info on specific brand homepages.
The second study, of 2,000, will look at how features like personal testimonial videos and interactive mechanism of action visuals on the brand sites influence understanding of risks and benefits. We will examine these special features in the context of the prominence of the presentation of risk information in two levels, more prominent and less prominent.
The third study, of 3,600, will look at whether links to and citations from external organizations, such as the American Heart Association, referenced on the brand homepages influence risk/benefit perceptions.
FDA states, In these three studies, participants will be randomly assigned to view one version of a (fictitious) prescription drug Web site. After viewing the website, participants will answer a series of questions about the drug. We will test how the manipulations affect outcomes such as perceived efficacy, perceived risk, behavioral intention, and accurate understanding of the benefit and risk information. In each study, the fictitious prescription drug will be for the treatment of a high prevalence medical condition and modeled on an actual drug used to treat that condition. Participants will be consumers who have been diagnosed with the medical condition of interest.
A 60-day public comment period on the study closes in June. For more information, or to comment, you can do so at the Federal Register.