FDA is collecting public comments on a series of studies that the agency plans to conduct on online direct-to-consumer (DTC) promotion of prescription drug products, according to an announcement in the Apr. 28, 2011, Federal Register.
The studies are designed to test different ways of presenting benefits and risks in DTC prescription-drug websites. The three experimental studies to be conducted will investigate whether presenting risk information on branded-drug websites influences consumers' perception and understanding of the risks and benefits of the product; how special features, such as personal testimonial videos and interactive visuals, on branded-drug websites influence perception and understanding of the risks and benefits of the product; and whether links to and citations from external organizations referenced on the homepage of branded-drug websites influence consumer perception and understanding of the risks and benefits of the product.
FDA gives the following justification for the project in the aforementioned announcement: “Pharmaceutical products are launched and marketed in a number of new modalities and venues that did not exist a short time ago. Increasingly, prescription products are promoted to consumers online in such formats as banner ads, Web sites, 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.”
The agency is specifically asking for feedback on these topics, including whether the proposed collection of information is necessary for the proper performance of FDA's functions; the accuracy of FDA's estimate of the burden of the proposed collection of information; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information on respondents.
Current FDA regulations require that prescription-drug advertisements include a “fair balance” of information about the products' benefits and risks of advertised products, and according to the Federal Register announcement, this balance must be clear in online DTC promotion. The research will therefore be “designed to test different ways of presenting prescription drug risk and benefit information on branded drug Web sites” and “will complement qualitative research we plan to conduct on issues surrounding social media,” says the announcement.
Details about the proposed studies are included in the Federal Register announcement. Comments are due June 27, 2011, and can be submitted at www.regulations.gov.