Advertising and Promotion Regulatory Affairs Conference

Historically regarded as non-promotional communications, disease awareness and help-seeking communications have surged and evolved over time. This session will explore what it means to actively promote and advertise a disease or condition – as opposed to a product – in the current legal and regulatory landscape. Approaches and best practices pre- and post- product approval may vary, including when disease awareness is conducted, the scope and extent of disease state or treatment information (e.g., product classes, treatment options), who shares it (e.g., Marketing, Medical, or Sales functions), to whom it is shared (consumers vs. healthcare providers), and why. Panelists will discuss whether the traditional considerations and hallmarks of disease awareness communications still apply in light of newer digital technologies and FDA’s First Amendment policy. Finally, this session will highlight related advertising activities – neither branded nor disease state education – in the form of unbranded ads such as digital banners and sponsored links.