FDA to Conduct Study on Direct to Consumer Side Effect Information and the Effectiveness of Listing Almost Everything

 

As recently noted, in 1997, pharmaceutical firms began advertising directly to consumers (DTC) via television ads, as a result of guidance from FDA that required drug advertisements to provide only a “brief summary” of side effects, rather than the full list required for print advertisements. Now FDA is considering further reducing the required disclosure of side effects on television ads. The agency has announced its intention to study the risks of reducing enumerated side effects to only those deemed “serious and actionable” (docket number FDA-2014-N-0168).

Coalition for Healthcare Communication Comment

In response, the Coalition for Healthcare Communication (CHC) submitted a comment to the FDA on its proposal to conduct research on the impact of limiting risks presented in 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.”

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. Based on the proposed sample size of 1,500 consumers, we assume the study will be quantitative. We feel that qualitative research would be helpful in identifying drivers and barriers to consumer understanding, as well as probing alternative paths to patient education.
• Include physicians in the study. Physicians obviously play an important gate-keeping role in the prescription drug market. It would be helpful to better understand how much time physicians typically spend discussing side effects with patients, as well as determining what level of familiarity with side effects, risk and benefits they prefer their patients to have before consulting them.

• Recruit respondents and analyze results by age cohort. The research habits and information expectations of different age groups differ dramatically. Any revisions to current policy should meet the needs of the full spectrum of consumers.
• Consider including communication media beyond television. We see the role of television changing for all our clients. We suggest exploring the right way to deliver side effect information across media — television, print, digital and social media.

• Reconsider using existing DTC ads in the proposed study. PhRMA recommended in its comment that the FDA not include existing DTC ads because consumers’ familiarity with these ads and the products’ side effects could skew the study’s results. The CHC concurs with this recommendation.

• Clearly define what “serious and actionable” risks are. We support selecting the most important risks to communicate (and would be happy to provide general risk assessment guidance), but would ask the agency to consider that companies will need to clearly understand which risks to include (e.g., The worst risks? The most common risks?).

First Amendment

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.”

FDA Study

Prescription drug advertising regulations (21 CFR 202.1) require that broadcast (TV or radio) advertisements present the product’s major risks in either audio or audio and visual parts of the advertisement; this is often called the “major statement.” 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. At the same time, there is concern that DTC TV ads do not include adequate risk information or leave out important information. These are conflicting viewpoints. 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. For example, the disclosure could be, “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 Office of Prescription Drug Promotion plans to investigate the effectiveness of this “limited risks plus disclosure” strategy through empirical research.

FDA’s hypothesis is that, relative to inclusion of the full major statement, providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks. FDA will also investigate other questions such as whether overall drug risk and benefit perceptions are affected by these changes. To examine differences between experimental conditions, FDA will conduct inferential statistical tests such as analysis of variance. With the sample size described below, FDA will have sufficient power to detect small- to medium-sized effects in the main study.