FTC Positive On FDA's Direct-to-Consumer Advertising Guidances
This article was originally published in The Pink Sheet Daily
Executive Summary
The Federal Trade Commission suggests that FDA should research consumer comprehension of risk information in print ads. The commission affirms its jurisdiction over "disease awareness" ads that do not mention a specific drug.
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FDA's proposed changes to the brief summary requirements for direct-to-consumer advertising will likely improve consumer comprehension of risk information, the Federal Trade Commission said in May 10 comments on the agency's "brief summary" draft guidance. "The FTC staff believes that requiring the disclosure of risk information in a more consumer-friendly format would be an improvement over the current brief summary requirement for DTC print ads," FTC's comments state. "The proposed change would mandate a more concise and consumer-oriented statement of risks, which makes it more likely that consumers will read and understand this information than the current risk information" taken directly from product labeling. FDA issued the brief summary draft guidance Feb. 4 (1 (Also see "Alternatives To Brief Summary Outlined In Draft Guidance" - Pink Sheet, 4 Feb, 2004.)). Research comparing consumer comprehension of different presentations of risk information is needed, FTC said FDA should "test the likelihood that consumers will read and understand drug risks" in print ads with no brief summary information; the brief summary information contained in broadcast ads; the brief summary options proposed by the guidance; and the currently required brief summary information. "Such research would provide insight into the costs and benefits of including different amounts of risk information in DTC print ads," FTC said. In addition, "the FTC staff believes that this broader research focus" will provide the FDA "with an empirical basis for selecting the best method of conveying such information to consumers in DTC print ads." Changes to the brief summary for print ads will also help bring the requirements in line with those for broadcast ads. "To the extent that the proposed changes would decrease the disparity between the brief summary requirements for DTC print ads and DTC broadcast ads, the current regulatory incentive to use DTC broadcast ads to compete may be decreased, although not eliminated," FTC noted. FTC also confirmed its jurisdiction in regulating "disease awareness" advertisements. FDA's disease awareness draft guidance, issued the same day as the brief summary draft, supports "help-seeking" advertisements that encourage consumers to seek treatment; however, regulation of such ads falls outside the agency's jurisdiction because they do not mention specific drugs. The guidance notes such ads would be regulated by FTC. "The FTC staff agrees with the FDA's suggestion that the commission would have jurisdiction over claims made in such communications even though they do not mention a particular drug." The draft guidance describes circumstances when an unbranded ad could be considered a promotion regulated by FDA. The Pharmaceutical Research & Manufacturers of America expressed concern that the guidance expands FDA's purview to regulate disease awareness ads "based upon vague or inappropriate criteria" (2 (Also see "FDA "Brief Summary" Changes Should Be Written In Regs - PhRMA" - Pink Sheet, 12 May, 2004.)). - Elizabeth Walker |