The Advertising Coalition Reminds FDA of First Amendment Limits to Advertising Regulation

May 9, 2016 – In an April 29 comment to the FDA on its recent proposal to conduct research on how animation in direct-to-consumer (DTC) prescription drug advertising affects viewer comprehension, The Advertising Coalition (TAC) asks the agency to consider the Office of Prescription Drug Promotion’s mission statement “in the context of a series of decisions in which the U.S. Supreme Court extended First Amendment protection to commercial speech.”

“While FDA has clear jurisdiction to regulate false and misleading advertising, it must ensure that those regulations adhere to the First Amendment,” according to Coalition for Healthcare Communication Executive Director John Kamp. “The TAC comment makes it clear that blanket bans on animated content are not allowed.”

In a March 2 Federal Register notice, the FDA stated that “it is important to examine whether animation in drug ads inflates efficacy perceptions, minimizes risk, or otherwise hinders comprehension of drug risks and benefits.” To that end, the agency proposes a two-part experiment to examine how both type of animation and non-human personification influence consumers.

The FDA plans to conduct two experiments that will be examined in two different medical conditions – chronic dry eye and psoriasis – and appears to be concerned about whether emotional responses to animated characters create positive effects that transfer to the brands advertised and also may lead to lower perceived risk by “minimizing or camouflaging side effects.”

The study’s findings “can inform FDA regarding how prescription drug risk and benefit information is processed.” Accordingly, the agency sought comment on research specifics (e.g., whether the FDA needs this information to perform its functions, whether it adequately is measuring the burden of information collection, etc.) as well as on two general research questions: (1) How does consumer processing of a DTC prescription drug ad differ depending on whether the ad is live-action, “rotoscoped” (i.e., used traced live-action images frame by frame to create animated characters) or animated? (2) Does consumer processing differ depending on whether the sufferer, the disease or the benefit is the focus of the animation?

TAC noted in its comment that the U.S. Supreme Court “for 40 years has defined and broadened the constitutional protections for advertising and other forms of commercial speech,” and that “one of the decisions in a long series of cases makes it clear that the use of a drawing or illustration is protected in addition to the text that it accompanies.”

The group asks the FDA to consider the case of Zauderer v. Office of Disciplinary Counsel, which involved a line drawing of a contraceptive device. In that case, the Court ruled that it did not accept the argument that the State of Ohio “may prohibit the use of pictures or illustrations in connection with advertising of any product or service simply on the strength of the general argument that the visual content of advertisements may, under some circumstances, be deceptive or manipulative.”

According to TAC, although the FDA and advertisers should “consider the impact that new visual characters and characterizations may have on viewers of the advertising,” the agency should “be mindful of [the] breadth of the protection that the U.S. Supreme Court has offered to advertising and its images and illustrations that often may be integral to that advertising.”