April 16, 2012 – The Coalition for Healthcare Communication (CHC) and The Advertising Coalition (TAC) recently told the FDA’s Office of Prescription Drug Promotion that a recent FDA study of “dual modality” risk disclosures does not support an FDA policy requiring both audio and text disclosures in all TV ads.

“Although TV ads for drugs should not be misleading, the already-extensive disclaimers imposed by FDA can be confusing and counterproductive,” said CHC Executive Director John Kamp.

“Adding a ‘dual modality’ requirement would make the problem worse, not better,” he said.

The CHC and TAC Comment to FDA was prepared in response to a Jan. 27, 2012, notice in the Federal Register. In the notice, the FDA stated that although the comment period on the proposed rule regarding the presentation of the major statement in TV ads closed June 28, 2010, it was reopening the comment period on specific data covering the impact of distraction on consumer understanding of risk and benefit information in DTC prescription drug TV advertising.

FDA analysis of the data from a study entitled, “Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements,” found that “presenting risk information at the same time in text and in audio improves consumers’ understanding of the risk information,” the notice stated.

However, CHC and TAC contend in their comment that the study does not provide support for the FDA “to venture into the creative design and formatting of advertising in a manner that would mandate a new regulatory standard that would require sponsors of television advertisements to communicate the major statement simultaneously in both audio and visual portions of the advertisement.”

Further, a dual modality requirement “would approach if not cross the important demarcation between prior restraint of advertising and a post-publication assessment that a particular ad is untruthful or misleading,” according to the comment, especially “in the context of nearly four decades of decisions by the United States Supreme Court that have extended the protection of the First Amendment to commercial speech.”