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April 21, 2014
Comments of members of the Patient, Consumer, and Public Health Coalition
on research entitled
“Disclosure Regarding Additional Risks in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements”
Docket No. FDA-2014-N-0168
Members of the Patient, Consumer, and Public Health Coalition applaud FDA’s efforts to clearly and effectively communicate risks and benefits to consumers in direct-to-consumer (DTC) advertisements. However, we are concerned about this study’s definition of “serious and actionable” risks, the diversity of the population being studied, the administration of the study in an online setting only, and the timing of the major statement in the ad (at the end of the ad instead of the beginning or middle).
The FDA document describes research plans to analyze the effect of limiting risk information in the major statement in DTC advertisements. This proposal would compare giving limited risk information in the major statement (combined with a disclaimer statement alerting consumers of additional undisclosed risks) versus using a complete major statement (as is currently used).
The aim of the research is to identify differences in participant understanding of the disclosure and perception of the risks and benefits of a particular medication, product quality, sponsor trustworthiness, and interest in the product. There is concern that overly long major disclaimer statements lead to reduced consumer attention, thereby compromising understanding of the presented risks.
We also have specific concerns regarding this proposal as follows:
- The definition of “serious and actionable” risks must be clarified. This research proposal describes limiting risks mentioned in the major statement in DTC advertisements to those which are “serious and actionable.” However, no definition is given for what medical risks would fall into this category. Detailed and explicit criteria must be set for what risks will be considered “serious and actionable.” As an informative example of this definition, FDA should also state what specific information will be included in the four versions of the major statement used for each patient group during this investigation. It should also be noted that some patients and consumers may have different preferences towards acceptable risk levels. For example, patients with a disease that lacks effective treatment are likely to be willing to take greater risks than patients for whom treatments are currently available, even if imperfect. FDA should describe how its definition of “serious and actionable” will take such diversity into account.
- A diverse participant population must be ensured. This research proposal does not include any specific information about how exactly the participants will be recruited for the investigation, other than stating that recruitment will take place online. We are concerned that recruitment which occurs solely through the internet may bias the participant population to younger and more affluent and Internet-adept populations who have easy access to the Internet. In fact, the consumers most likely to be reached online may be those who are least likely to watch commercials on TV. FDA needs to describe in detail how it will ensure a diverse participant population in terms of age, race, gender, ethnicity, and educational background. These factors could heavily influence perception of the presented information, and thus skew the results of this investigation. As FDA plans to recruit participants who self-identify as having one of three possible medical conditions, the nature of these medical conditions could also introduce bias into the participant population. Care must be taken to ensure adequate diversity to reflect the general U.S. consumer audience.
- The study conditions must be as similar to real life situations as possible. This proposal describes the study as being administered in an online setting only. This situation, under a conscious test scenario, sitting close to a personal computer, is very different from the situation in which direct-to-consumer advertising usually takes place, which is often during leisure time in the presence of other distractions, where the consumer often sits further from the screen. FDA should consider ways to make its test protocol more realistic in order to account for these differences.
- Other changes to the major statement, such as timing, should also be considered in the test. Given that the major statement usually occurs at the end of an advertisement, having a shorter major statement alone may not guarantee increased consumer comprehension under real world situations. One consideration would be to introduce another version of the advertisement to the test protocol, in which the major statement is given earlier in the advertisement, when a greater proportion of consumers may be paying attention.
Lastly, we must note that the length and types of risk information provided in direct-to-consumer advertising are not the only variables that influence whether patients pay attention and understand that information. For example, TV commercials continue to provide risk information while visual and auditory stimuli are distracting the viewer from the risks being listed. In other words, the FDA has continued to allow companies to design and use ads that are clearly intended to persuade consumers to request their products and to encourage them to ignore risk information, rather than to educate them about the true risks and benefits. In the absence of comparative effectiveness research, the FDA also continues to approve new medical products with little benefit compared to other treatment alternatives, and then regularly gives companies numerous opportunities to mislead consumers in their advertisements, using a much lower threshold for accuracy than the FTC’s criteria of “misleading the average consumer” for food and supplement advertising.
American Medical Student Association
American Medical Women’s Association
Annie Appleseed Project
Breast Cancer Action
Community Access National Network
Connecticut Center for Patient Safety
Jacobs Institute of Women’s Health
National Consumers League
National Research Center for Women & Families
National Women’s Health Network
The TMJ Association
Center for Science and Democracy at the Union of Concerned Scientists
For more information, contact Anna Mazzucco, PhD at (202)223-4000 or email@example.com