Advertising and Promotion Regulatory Affairs Conference

Since the 2018 issuance of FDA’s guidance on Medical Product Communications that are Consistent with FDA-Required Labeling, we have seen a proliferation of this information being included in prescription drug promotion. The new evidentiary standard, scientifically appropriate and statistically sound (or SASS), defined in the guidance is a flexible standard whose robustness varies with the nature of the information being communicated. While this presents opportunities for sponsors to expand on the data and other analyses used in promotion, it also presents challenges in terms of ensuring the supporting evidence is adequate in each instance, not to mention appropriately contextualized with study design limitations and other relevant disclosures. During this session, we will examine approaches to CFL assessment, the characterization of CFL information in promotion, and lessons learned from FDA’s CFL-related enforcement since the guidance was issued.