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Session 8: Use of Consumer CFL in Promotional Materials
Session Chair(s)
Georgina Lee, PharmD
Executive Director, Regulatory Advertising and Promotion
Sage Therapeutics, United States
This session will focus on the FDA Guidance for Medical Product Communications that are Consistent with the FDA-Required Labeling (CFL) and how it can be applied to Direct-to-Consumer (DTC) promotional materials. Consumer-facing materials frequently present challenges as the content needs to be truthful, non-misleading, and fairly balanced while being easily understood by the lay audience and consumer. With a focus on DTC materials, we will evaluate the important considerations for incorporating CFL communications into promotional materials and examine trends and best practices across the industry.
Learning Objective :
- Describe how to assess CFL claims in the context of consumer-facing materials based on the FDA Guidance
- Apply learnings to consumer messaging across various platforms and material types
- Identify opportunities to leverage CFL claims in patient-facing materials with appropriate context
Speaker(s)
Speakers
Georgina Lee, PharmD
Sage Therapeutics, United States
Executive Director, Regulatory Advertising and Promotion
Speakers
Lynette Hopkinson
CoRA Consulting LLC, United States
Principal
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