Feb. 17, 2014 – In recognition that the stream of risks currently disclosed on direct-to-consumer (DTC) television ads may be so detailed that they have become white noise, the FDA is announcing in the Federal Register due to be published Feb. 18 (2014-03390) that it will study what impact limiting those risks to the most serious would have on consumers’ understanding of an advertised product’s possible side effects.

“The FDA may have given the listening public and the industry a Valentine’s gift by announcing its intent to do a research study of the required ‘major statement’ of contraindications and side effects in all broadcast ads,” remarked Coalition for Healthcare Communication Executive Director John Kamp. “Consumers clearly would benefit from a focus on primary risks that does not include every possible side effect spoken at a rapid-fire pace,” Kamp said.

Indeed, the agency states in the Federal Register notice that “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 continues by stating 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.”

However, the agency remains concerned that adequate risks still need to be communicated, and suggests the following type of disclosure: “This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for [drug name] before starting it.” The FDA hypothesizes that providing an abbreviated major statement with this type of disclosure “will promote improved consumer perception and understanding of serious and actionable drug risks.”

The FDA’s Office of Prescription Drug Promotion “will investigate the effectiveness of this strategy through empirical research,” according to the notice. The study will include 1,500 respondents who will be randomly assigned to view one of four possible versions of an ad:

1. Full major statement without the disclosure regarding additional risks
2. Full major statement plus the disclosure about additional risks
3. An abbreviated statement of risks without the disclosure about additional risks
4. An abbreviated statement of risks plus the disclosure about additional risks.

After reviewing one of the versions, participants will be asked to answer questions about the information presented in the ad that are designed to assess perception and understanding of product risks and benefits; perception and understanding of the disclosure about additional risks; perceptions of product quality; intention to seek more information about the product; and perceptions of trust/skepticism regarding product claims and the sponsor.

The agency is accepting comments on the proposed study until April 21, 2014. CHC members interested in contributing to the CHC comment on this matter should contact John Kamp at (703) 801-4582 or jkamp@wileyrein.com.