Earlier this summer, the U.S. Food and Drug Administration (“FDA”) issued a notice, as required by federal law, that describes the agency’s intent to conduct research examining “how firms communicate about prescription drugs from the perspective of medical conference/exhibit hall attendees.”
As noted by the FDA in justification for the study, “medical conference exhibit booths provide opportunities for pharmaceutical companies to market to large numbers of HCPs and potentially engage in more lengthy interactions.” However, “recent compliance letters issued by… [the FDA] 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.”
Over the next year, the FDA will survey healthcare providers who have attended certain medical conferences, in part to capture prescriber observations regarding the conferences. The agency will select conferences focused on therapeutic areas with the following attributes: (i) high number of promoted branded medications; (ii) high prescription volume; (iii) large patient populations; and, (iv) high amount of new drug development and promotional spending.
Key Takeaway
Although the FDA study is research-focused at this time, the findings of the study may inform other stakeholders, including federal and state enforcement agencies, who have in the past scrutinized the interactions between prescribers and pharmaceutical companies at medical conferences, particularly with respect to false or misleading off-label promotion of drugs and marketing activities.
How Frier Levitt Can Help
Sponsorship or promotional activities undertaken at pharmaceutical or medical conferences can be rife with regulatory pitfalls. As such, any individual or entity that engages in conference-related sponsorship or promotional programs should ensure that their programs are evaluated by experienced healthcare counsel. Contact Frier Levitt for a review of your sponsorship or promotional activities.
