July 29, 2021 – Because medical conference exhibit booths provide opportunities for pharmaceutical companies to market their products to large numbers of healthcare professionals (HCPs), the FDA’s Office of Prescription Drug Promotion (OPDP) is planning to study how exhibit materials and conversations between booth reps and HCPs affect HCPs’ perception of promoted drugs.
OPDP cites a 2006 study which found that at least 80 percent of physicians attended at least one medical conference per year and spent an average of seven hours on the exhibit hall floor and between 12 to 21 minutes at each booth, a much longer period than these physicians spent with drug detailers in their offices (five to 10 minutes on average). Accordingly, “investigating the impact of pharmaceutical booth promotions among medical conference attendees has valuable practical implications for the public health,” OPDP stated in a July 14 Federal Register notice announcing its study.
The study will be done in two parts:
- OPDP will ask attendees who are prescribers – primary care physicians, specialists, nurse practitioners and physicians assistants – general questions about their attendance at medical conferences, including why they attend, which conference activities they attend, and their opinions about the prescription drugs promoted at medical conferences.
- OPDP will collect data about interactions between drug company staff and HCPs. OPDP will simulate interactions that HCPs may have at medical conference booths promoting pharmaceuticals in order to examine the effects of the booth representative’s background – science/medical background versus business professional – and disclosure of data limitations – present versus absent.
“The perceived credibility of the booth representative and the availability of information on data limitations could ultimately inform HCPs’ perceptions of the risks and benefits of drugs presented at exhibit booths and their decisions to prescribe drugs to patients,” OPDP states. Indeed, OPDP also notes that it has issued enforcement letters in the past for booth and panel displays that “communicated misleading information regarding drug efficacy and safety, provided insufficient information regarding drug efficacy and safety, provided insufficient information on drug risks and omitted ‘material facts’ about the promoted drug.”
To study these issues further, OPDP will ask for attendees’ general observations regarding:
- Disclosures or disclaimers accompanying exhibit hall presentations and/or symposia (about data limitations, contrary data, FDA approval status, financial/affiliation sponsorship, etc.);
- Publications or references accompanying the presentation of information (PI for approved indications, contrary data references, etc.);
- What type of studies are being reported (real world evidence, pharmacokinetic/pharmacodynamic studies, meta-analyses, etc.).
- Who makes the presentations (field of study, training); and
- Where the presentations are made (poster session, scientific floor, exhibit hall).
OPDP also will address exhibit hall pharmaceutical booth interactions with the following questions:
- How does the presence or absence of information about the limitations of data influence perceptions of the promoted product?
- How does the background of the booth representative influence perceptions of the promoted product?
- Do these two variables interact?
OPDP is accepting written comments and recommendations on the study’s information collection activities by Aug. 13.