The FDA’s Office of Prescription Medicine Promotion (OPDP) intends to know how patients and doctors consider the risks and benefits of a new prescription medicine before starting it. What factors influence treatment decisions, and how do people choose one medication over another? A new study by the OPDP will seek to answer these questions.
The research will focus on type 2 diabetes as well as psoriasis, with 800 patients and 800 physicians with or specialising in those conditions being divided into two groups to compare their preferences. In a 20-minute process, respondents will be able to make particular decisions on the basis of profiles of phoney prescription medications.
According to the OPDP Federal Register notice, the data from these selections will be used to explore the choices that consumers and physicians are prepared to make to prevent or accept specific attribute levels. Statistical tools will be utilised to determine the value that patients and doctors place on various product aspects, as well as their relative importance.
In a March news release, OPDP senior social science assessment and study team lead Kit Aikin remarked that by using social science concepts, the research reveals hurdles that may hinder consumers from completely appreciating the drug’s risk-benefit profile. Similar research has been carried out to determine what motivates customers to choose one product over the other. The OPDP submitted a study about medicine names in 2020, asking consumers and healthcare professionals to choose from seven names, including one that is extremely, explicitly suggestive and one that is intentionally impartial.
This year, the OPDP has been trying to crack down on false psoriasis and diabetes promotion. Eli Lilly was penalised by the FDA in January for a social media post marketing its diabetic drug Trulicity that generated a false picture about the extent of the FDA label. In late March, the OPDP accused Bausch Health of creating false or misleading representations in a video commercial about the hazards and effectiveness of their psoriasis cream, Duobrii. The video has now been taken down from YouTube as well as other online services, indicating that the FDA is paying very close attention to the promotion of psoriasis and diabetes medications.
According to Endpoints News, the FDA’s Center for Drug Evaluation and Research expects the study to be completed by 2024. For 60 days, the OPDP will take public opinions on the proposed study.