FDA has announced that the Office of Prescription Drug Promotion (OPDP) is planning a study to evaluate the influence that statements made in a promotional communication about patient adherence to a medication may have on the resulting preference for a medicine.
OPDP regularly conducts research on a wide-ranging scale to help define the agency’s perspective on how various conditions might impact a target audience of a promotional communication. In particular, the agency states in the Federal Register notice that it has previously conducted research around market claims that discuss characteristics not directly related to approved label. They give the example of past research on the use of the phrase “#1 Prescribed”, for example, assessing the impact it might have for preference. Here, you can find an overview of OPDP’s past research, on-going research and research pending peer review and publication.
For this particular research, OPDP is seeking to gain insight into how an appeal to the possibility of greater adherence or whether or not there is a statement that other patients or prescribers prefer a specific medicine might impact the outlook of the target audience. In addition, they will look at whether the inclusion of a disclosure accompanying such a claim – for example “there is no conclusive research on whether DRUG A results in better adherence” – will serve to impact the perception. OPDP notes in the Federal Register Notice that while disclosures often can help shape an outlook, they have not been studied in this particular context.
The specific questions FDA is seeking to answer in this proposed research effort is whether the presence of absence of a stated or implied adherence claim impact consumer outlook with respect to their intent or perception of risk and benefit. In addition they will explore whether the presence of both adherence and preference type of claims have an impact, as well as exploring the effect of the presence of a disclosure statement as noted above. The agency is including both patients and primary care physicians, looking for 253 and 294 participants respectively. Each participant will view various versions of a mock consumer web page promoting a fictitious medication and respond to a questionnaire.
There is a long tail to this type of research. It will have to be finalized, recruited, assessed and written up as well as undergo peer review. But in informing the agency’s perspective on a particular topic, the research undertaken by OPDP may be a window into future directions, considerations and even potential priorities for the agency in terms of enforcement. Those in promotional communications may wish to take note now.