May 2, 2014 – The Coalition for Healthcare Communication believes that “shorter, simpler disclosures are most likely to lead to robust doctor-patient conversations and better health outcomes,” according to a comment the CHC submitted to the FDA today on its proposal to conduct research on the impact of limiting risks presented in direct-to-consumer (DTC) prescription drug television ads.
“The Coalition supports the FDA’s investigation of whether it makes sense to curtail the laundry list of risks in DTC TV ads, because, frankly, it seems that consumers are either terrified of risks that may be rare or are no longer even paying attention to the risk disclosures because they have become ‘white noise,’” said CHC Executive Director John Kamp. “Our comment provides support for the position that less is more when it comes to communicating important risks to consumers.”
A Feb. 18 Federal Register notice announcing the proposed research stated “There is concern that as currently implemented in DTC ads, the major statement is often too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects.” The notice also stated that “a possible resolution is to limit the risks in the major statement to those that are serious and actionable, and include a disclosure to alert consumers that there are other product risks not included in the ad.”
In its comment, the Coalition cites several studies supporting the argument for this resolution and the agency’s hypothesis that a truncated list of risks in TV ads will promote consumer understanding of serious and actionable drug risks. The comment also points out to the agency that it should be generally wary of the effectiveness of mandatory disclosures.
The Coalition asked the FDA to consider doing the following as it formulates its DTC TV ad study plan:
- Include a qualitative leg to the study.
- Include physicians in the study.
- Recruit respondents and analyze results by age cohort.
- Consider including communication media beyond television.
- Reconsider using existing DTC ads in the proposed study.
- Clearly define what “serious and actionable” risks are.
The FDA also should bear in mind that the First Amendment puts the burden on the agency “to demonstrate that its rules and policies – in this case the disclosure mandates – are necessary to serve FDA’s interest in ensuring that consumers are not deceived by ads,” according to the CHC comment, which references citations for court decisions in Sorrell v. IMS Health and United States v. Caronia.
“Anyone in the communications industry knows that the fewer messages you try to get across in a TV ad, the better,” Kamp added. “The same holds true for prescription drug ads on TV,” he continued. “We want consumers to comprehend the reasonable risks while also understanding the benefits. This study could be a way to validate that approach.”