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# Comments on Proposed DTC Animation Study
- URL: https://www.fdaweb.com/comments-on-proposed-dtc-animation-study/
- Published: 2016-11-02T12:00:00.000Z
- Updated: 2026-09-14T21:44:40.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137237

Recent comments on an FDA proposal to study use of animation in direct-to-consumer advertising highlight concerns about the study as well as its potential benefits. The Advertising Coalition urges the agency to be aware of Supreme Court protections for commercial speech, including advertising. Its [letter](https://www.regulations.gov/document?D=FDA-2016-N-0538-0042&ref=fdaweb.com) particularly cites a case in which the state of Ohio attempted to regulate the use of illustrations in advertising. The Supreme Court reversed a lower court decision and said that “acceptance of the state’s argument would be tantamount to adoption of the principle that a state 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.” The coalition says that as new forms and methods of advertising are adopted and deployed in the visual and digital environment, it agrees that it is important for FDA and advertisers to consider the impact that new visual characters and characterizations may have on advertising viewers. “We respectfully urge FDA to 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,” the letter concludes.

GlaxoSmithKline’s comment [letter](https://www.regulations.gov/document?D=FDA-2016-N-0538-0043&ref=fdaweb.com) discusses the reasons that a drug sponsor might choose to use animation in drug advertising. As a result, it says, the proposed research may oversimplify animation as one homogenous type of ad technique. The company also includes comments on specific attributes of the proposed research.

Regeneron [says](https://www.regulations.gov/document?D=FDA-2016-N-0538-0041&ref=fdaweb.com) it agrees there is a need to learn more about how consumers process prescription drug risk and benefit information provided in animation TV ads. It urges FDA to acknowledge the exploratory nature of the study and to indicate that the results would not be generalizable to other patient populations and medications with different levels of risk.

In its [comments](https://www.regulations.gov/document?D=FDA-2016-N-0538-0045&ref=fdaweb.com), Merck says that while the proposed collection of information may be interesting to learn, it may not have practical utility for the general public and may be unnecessary for the proper performance of FDA’s functions. It also notes the other DTC television research studies the agency has underway and suggests that before implementing results of the individual studies, FDA should consider conducting research and further analysis on how the individual elements combined and presented together would affect the overall communication of an advertised medicine’s potential benefits and associated risks.

Finally, AbbVie [says](https://www.regulations.gov/document?D=FDA-2016-N-0538-0047&ref=fdaweb.com) it is important for sponsors of TV ads to understand the impact of animation on the effective communication of prescription drugs’ benefits and risks. “In particular,” it says, “what are the ways in which animation can be used to enhance effective communication versus the ways in which it can detract? For example, we are interested in learning whether differing forms of animation may better explain product benefits and risks, mechanism of action, disease state, and drug administration, and now the use of animation compares to alternatives. Likewise, it also is important for the agency to understand if the use of animation may stimulate consumers to use another device while watching TV, including smartphones and tablets, as consumers search for information on products/services shown in the commercial.”