FDA recently announced that the Office of Prescription Drug Promotion (“OPDP”) initiated a new study on pharmaceutical companies’ interactions with healthcare providers at promotional booths in medical conference exhibit halls. The study is intended to yield insights to inform OPDP policy making and review of proposed promotional materials submitted by companies seeking advisory comments. It may also generate insights that may be used by DOJ to pursue companies for potential instances of off-label promotion or making statements about safety or efficacy that could be characterized as false or misleading.
As Sidley lawyers Jaime L.M. Jones, Brenna E. Jenny, and Coleen Klasmeier discuss in an article published in Law360, the study—which launches beginning this month—serves as a reminder that promotional booths remain a source of potential risk. Particularly as conference activity picks up after a pandemic-necessitated suspension, drug companies should be refreshing training and other compliance efforts designed to ensure that promotional materials provided through medical conference exhibit hall booths comply with applicable legal and regulatory requirements.
A copy of the article is available here.