FDA published notice recently that the Office of Prescription Drug Promotion (OPDP) was proposing some new research related to the promotion of medicines by pharmaceutical companies. The research was new (kind of) but the direction was more of the same old focus – direct-to-consumer advertising (DTC).
First, just a note on why the research is of importance at all. OPDP engages in a fair amount of formal study related to various aspects of its mission to protect public health by ensuring that prescription drug promotion is truthful, balanced, and accurately communicated. To that end OPDP employs a broad range of methodologies to explore the impact of various aspects of promotional practices and speech to evaluate impact. The resulting outcome is a body of evidence that (1) can influence either the development of new guidance, or (2) the revision of existing guidance or (3) inform patterns and priorities of enforcement by the agency – and that is why we take note.
Research that is currently underway spans a number of topics, including the use of animation in DTC promotion, the impacts of disease awareness and prescription drug promotion on television, the use of superimposed text in DTC promotion, to name a few. A full list can be found here. And here are the latest being added by OPDP:
- Endorser Status and Actual Use in Direct-to-Consumer Television Ads – We have all seen ads on television where a person endorses a medicine. Are they effective? Who do we listen to? In fact, OPDP has already conducted one study to determine how different types of endorsers in print or internet settings and the impact of disclosure of payment status influenced audiences. The agency also noted that prior research has shown that different endorsers have different impacts – with expert physicians and pharmacists being the ones most likely to lead to purchase intentions, with consumers falling behind them and celebrities bringing up the rear. The new research will focus specifically on television advertisements to assess the impact of the disclosure of payment in an ad by an endorser. OPDP will examine endorser type (patient, physician) and will look at the impact of actual use disclosures. The agency is going to examine whether there is a difference of perception by age and education level.
- Perceptions of Prescription Drug Products with Medication Tracking Capabilities – There have been multiple approaches to supporting patient adherence to taking prescribed medications, ranging from pills with ingestible sensors to mobile apps. OPDP states that there is not much known about the perceptions of patient and health care providers that track medication use or work with a software element to track use. Specifically, OPDP is looking to know when a promotional communication conveys the information about ability to track use, the agency is seeking to assess how that fact may impact the perspective of the audience around risk and benefit.
- Targeted Mechanism of Action Presentations in Prescription Drug Promotion – When a drug promotion contains the term “targeted” OPDP wants to know if that has an effect on a person’s perception of the safety and efficacy of the product. This is based on a 2014 focus group of healthcare professionals in which OPDP even admits, there was a diversity of opinions but where some may have expressed a tendency to view a product more favorably if the term were used. OPDP is now conducting a survey that looks at how physicians and consumers might interpret a number of terms, including “targeted”. Now OPDP will engage in a study to assess the influence of “targeted mechanism of action” language and use of graphics related thereto in promotional communications.
As one can see, OPDP meticulously follows a thread, sometimes over years, to add definition and context to promotional communications, often highly nuanced. However, the agency has been largely entrenched in its research in traditional communications vehicles – DTC in print and broadcast, for example, without embarking more broadly on research that would provide insight into digital communications. Given the 2009 framework for addressing the regulatory issues associated with digital and social communications and the huge migration by consumers to those platforms and the vigorous use of the Internet in health-seeking information, it would make sense for the research to follow suit. That is particularly true given that the 2009 framework has only been partially addressed by the agency. But for now, we wait.