The United States Food and Drug Administration (FDA) recently announced a proposed collection of information entitled “Medical Conference Attendees' Observations About Prescription Drug Promotion.” The proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review. The study, published in the Federal Register on July 14, 2021, will be conducted by the Office of Prescription Drug Promotion (OPDP).
The study will focus on three main topics: advertising features (content and format); target populations and research quality to understand the landscape of promotion of prescription drugs at medical conferences to healthcare providers generally and will specifically measure how the different elements of pharmaceutical booths in exhibit halls impact attendee drug perception as promoted within that booth. The study, which consists of two parts, will start by asking event attendees/prescribers within different disciplines (e.g., primary care, nurse practitioners) general questions about their attendance at medical conferences, including questions about what motivated them to attend, which activities they intend to participate in, and their views regarding prescription drug treatments promoted at medical conferences. OPDP will seek more detailed information in the second part of the study regarding HCP interactions in medical conference exhibit halls. Attendees will be recruited from large medical conferences representing a variety of specialties and medical areas in the U.S. over the course of one year, focusing on conferences with therapeutic areas that have multiple attributes, including high volume prescriptions and large patient populations. The Federal Register Notice also includes a list of proposed research questions and a more detailed description of the possible method to conduct such research.
FDA notes "medical conference exhibit booths provide opportunities for pharmaceutical companies to market to large numbers of healthcare providers and potentially engage in more lengthy interactions." Additionally, as part of the research, interactions that HCPs may have at medical conference booths will be simulated, so that FDA can examine the effects of the booth representative’s background (scientist/ medical professional versus business professional) and disclosure of data limitations.
According to FDA, "This study is designed to provide insights to inform the advisory comments that OPDP provides to pharmaceutical companies that voluntarily seek FDA review."
The Collection of Information details multiple comments which were due by July 13, 2021, and FDA's responses.
The Federal Register is available here.
For more information regarding OPDP Research, please see the OPDP Promotional Violations section of the Enforcement Actions Database.