In mid-July 2021, the United States Food and Drug Administration (FDA) published a proposed collection of information in the Federal Register. Under the proposed collection of information, the Office of Prescription Drug Promotion (OPDP) will focus on “understanding the landscape” of healthcare provider-directed promotion of prescription drugs at medical conferences, with a specific focus on how different elements of pharmaceutical booths in exhibit halls at medical conferences impact the attendees’ perception of the drugs that are promoted at those booths.
To conduct the study, OPDP will first ask event attendees/prescribers within different disciplines general questions about their attendance at medical conferences, including questions about their motivations for attending, which activities they participate in, and their opinions about the prescription drug treatments promoted at medical conferences.
Then, under the second part of the study, OPDP will seek more detailed information about the interactions in medical conference exhibit halls. In the Federal Register notice, OPDP cites to a 2006 study that found that at least 80 percent of physicians attended at least 1 medical conference each year and spent an average of 7 hours on the exhibit hall floor at each event with the length of time spent at each booth between 12 and 21 minutes. That was longer than detailing visits in healthcare provider offices, which range from 5 to 10 minutes on average. Therefore, OPDP believes that medical conference exhibit booths provide opportunities for pharmaceutical companies to not only market to large numbers of healthcare providers, but also potentially engage in more lengthy interactions.
As part of the specific exhibit booth research, OPDP plans to simulate interactions that HCPs may have at medical conference booths promoting prescription drugs, so that FDA can both the examine the impact of the booth representative’s background (scientist/medical professional versus business professional) and disclosure of data limitations (present versus absent).
Research Questions and Method
In conducting the study, OPDP will ask for attendees’ general observation of certain things, including: disclosures or disclaimers accompanying exhibit hall presentations and/or symposia; publications or references that accompany the presentation of information; what type of studies are being reported; who makes the presentation; and where the presentations are made.
OPDP will also look to how the presence/absence of information about the limitations of data influences perceptions of the promoted product and how the background of the booth representative influences perceptions of the promoted product.
OPDP plans to recruit attendees of 12 select medical conferences in the United States over the course of 1 year, representing a variety of specialties to reflect medical areas that have prescription treatments that may be promoted to healthcare professionals. However, it may take some time for this study to be completed as there have only been a limited number of conferences with in-person attendees since March 2020 due to the COVID-19 pandemic. Skewed results may also wind up being a problem as it is likely those attendees at in-person events spend more time at exhibits than normal as they are catching up.
Comment Period Open Until August 13th
This announcement falls in line with compliance letters issued by OPDP described booth or panel displays that communicated misleading information regarding drug efficacy and safety, provided insufficient information on drug risks, and omitted ‘‘material facts’’ about the promoted drug. OPDP believes that one of the main reasons that physicians and other medical professionals visit specific exhibits at conferences is to obtain product information. Therefore, the information provided by exhibitors to healthcare providers regarding the risks and efficacy of prescription medications not be false or misleading.
Interested stakeholders can submit written comments – including recommendations – on the collection of information no later than August 13, 2021.