What is the appropriate amount of risk information when engaging patients in the context of direct-to-consumer (DTC) prescription drug advertising? The FDA has issued a notice that it is accepting public comment on a study that will “investigate the impact of limiting the risks presented in DTC prescription drug television ads to those that are serious and actionable, and including a disclosure to alert consumers that there are other product risks not disclosed in the ad.”
It’s an interesting and important question among so many interactions at the individual level whether it be through traditional advertising or even social media. The concept of the engaged and informed patient is a cornerstone in the ongoing conversation about better health outcomes. However, more information may come at a cost to the patient when it comes to comprehending the complete message in the advertisement. The FDA study attempts to investigate this conundrum:
There is concern that as currently implemented in the 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.
However, even when a patient is empowered with information (e.g., the risks of side effects) at any level of detail she must also engage her physician — not only for beginning a treatment plan but also for continuing this interaction to measure health outcomes, which might that also include possible side effects.
The FDA invites comments on four topics with regard to this investigation:
1. whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
2. the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. ways to enhance the quality, utility, and clarity of the information to be collected; and
4. ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms and other forms of information technology.
So one question might be whether or not it really matters how much the disclosures of prescription drug risks are limited in DTC ads given that the physician-patient interaction remains at the heart of the treatment plan. These disclosures may be overwhelming for the layperson, and in the context of the patient’s electronic health record represent a subset of even more information that requires the advice and interpretation of her physician(s).
Robert Green is the author of Community Healthcare: Finding a Common Ground with New Expectations in Healthcare. Through his physician client relationships, Bob has gained substantial insight regarding the daily challenges that medical professionals and their staffs face, such as regulatory issues, financial management, and clinical collaboration through the use of health IT. His process of making both interpersonal and purposeful connections within the organization results in improved employee performance and confidence and enhanced client experience.