Drug advertisements that the Food and Drug Administration (FDA) believes minimize a product’s risks have long been one of the Agency’s prime enforcement targets. In drug ads on TV, we are now accustomed to expecting a laundry list of risks that seems to dwarf any potential good that a drug might offer. Indeed, this list—often called the “major statement” is required for any promotion that qualifies as a product-claim advertisement.
In February 2014, FDA announced that they were interested in studying the effect of this list in direct-to-consumer ads on TV. “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 non-compliance due to fear of side effects,” states the Agency. “At the same time, there is concern that DTC TV ads do not include adequate risk information or leave out important information.”
FDA explains 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. FDA plans to investigate the effectiveness of this “limited risks plus disclosure” strategy through research.
The Agency’s hypothesis is that, compared 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.” The agency’s study will involve participants over the age of 18 assigned to one of four groups:
- (1) Ad will present the full major statement without the disclosure regarding additional risks.
- (2) Ad will include the full major statement plus the disclosure about additional risks.
- (3) Ad will include an abbreviated statement of risks without the disclosure about additional risks.
- (4) Ad will include an abbreviated statement of risks as well as the disclosure about additional risks.
After viewing the ad, participants will respond to questions about information in the ad. Measures 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.
When FDA planned the study last year, they opened their research methods up to comments. Last week, they released their responses to some of the suggestion or concerns over the study from various stakeholders. The full question and answer list is available here.
The agency directly addressed comments and recommendations made by 26 groups or individuals, including the Coalition for Healthcare Communication. The Coalition’s Executive Director John Kamp stated: “The Coalition supports the FDA taking a closer look at taking a scaled-back approach to risk disclosure in DTC TV ads…The fewer messages you try to convey in a TV ad, the better. With a ‘less is more’ approach, consumers will be able to comprehend a drug’s reasonable risks while also understanding its benefits.”
The following lists the Coalition’s recommendations to the FDA and excerpts from the agency’s responses (Coalition comments in bold).
Include a qualitative leg to the study. Cost considerations restrict us from doing so. Note however that we do intend to conduct cognitive interviews prior to administration of the main study. … Findings from the cognitive interviews will then inform development of the final stimuli and questionnaire.
Include physicians in the study. We agree that physician perspectives about prescription drug advertising are important and interesting. However, as their perspective is outside the scope of the current research, we do not intend to adopt this suggestion. Note that we recently completed a separate study examining this topic, entitled “Healthcare Professional Survey of Prescription Drug Promotion.”
Recruit respondents and analyze results by age cohort. We agree that recruiting participants across a wide range of ages is important and our sample will reflect this shared perspective.
Consider including communication media beyond television. We understand that it is important to understand effects of prescription drug advertising across mediums. … We intend to focus on television advertising in this study because it is most closely related to the research objectives, and due to cost considerations.”
Reconsider using existing DTC ads in the proposed study. The decision to implement and modify existing ads was arrived at in an effort to balance the integrity of the research with cost considerations. … We appreciate this concern and in response, we have added questions to the survey to measure ad familiarity, which we can then control for in our analyses. … Our goal in using existing information is to ensure external validity of study findings when we draw comparisons between consumers who view existing versus modified risk statements.
Clearly define what “serious and actionable” risks are. We define “actionable” as something the patient would know (e.g., pre-existing condition or allergy) or recognize (e.g., observable physical or mental symptom) and can act upon to help mitigate (e.g., get immediate medical help to prevent a bad outcome). … Serious risks would include those that appear in the warnings and precautions section of labeling and results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening or require hospitalization may be considered a serious adverse drug experience when, based on appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed previously.
“FDA clearly paid close attention to all the comments submitted on their initial proposal, including the comments of the Coalition,” Kamp noted. “It’s a model on how research and policy ought to be done. We also thank those members of the Coalition who contributed to the development of the formal comment.”
Comments on the January 13 notice are due by February 12. (Available here)
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What else is on the plate for DTC research?
FDA’s latest direct-to-consumer advertising study is going to assess whether the number of times consumers see drug ads changes their perception. The study is entitled Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads.
“In a typical promotional campaign, consumers may be exposed to a DTC prescription drug ad any number of times,” states FDA. “To our knowledge, the literature concerning ad exposure frequency has not been extended to include specific attention to prescription drug ads.” This is fertile ground for study: “Prescription drug ads are unique in that they are required to provide both benefit and risk information whereas other ad types tend to include only benefit information.” FDA plans to examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in DTC prescription drug ads through empirical research.