The FDA’s Office of Prescription Drug Promotion (OPDP) wants to find out how patients and physicians weigh the trade-offs between risks and benefits when starting a new prescription drug. What characteristics influence treatment choices and how do people reach the decision for one drug over another? The OPDP will be answering these questions through a new study (PDF).
The study will focus on Type 2 diabetes and psoriasis, splitting 800 patients and 800 physicians who have or specialize in those diseases to compare the preferences of the two groups. Participants will be asked to make specific choices based on profiles of fake prescription drugs in a process that will take 20 minutes.
The data from these choices will be used to “explore the trade-offs that consumers and physicians are willing to make to avoid or accept specific attribute levels,” according to the OPDP Federal Register notice. Statistical techniques will be used to estimate the value patients and physicians place on different product characteristics and the relative importance of these attributes.
“Using social science principals, our research identifies barriers that may prevent people from fully grasping the drug's risk-benefit profile,” said OPDP senior social science analysis and research team lead Kit Aikin in a March news release.
Similar studies have been conducted to determine what exactly drives consumers to select a product over others. In 2020, the OPDP filed a study about drug names, asking consumers and healthcare providers to choose between seven names including an “extreme, explicitly suggestive name” and purposefully neutral ones.
The OPDP has been cracking down on misleading marketing for psoriasis and diabetes this year. In January, the agency sent a letter reprimanding Eli Lilly for a social media post promoting its diabetes medicine Trulicity that gave a “misleading impression about the scope” of its FDA label. More recently, in late March, the OPDP called out Bausch Health for “false or misleading claims” regarding the risks and efficacy of its psoriasis cream Duobrii in a video advertisement. The video has since been removed from YouTube and other online services, suggesting the agency is paying careful attention to psoriasis and diabetes drugs marketing.
The FDA’s Center for Drug Evaluation and Research expect the study to wrap up by 2024, the agency told Endpoints News. The OPDP will accept public comments on the proposed study for 60 days.