Biopharma (includes Biologics)

AdPromo: Same, Similar, or Superior Claims

Tuesday, September 15, 2020

1:00 PM – 2:30 PM EDT

Moderator(s)

Glenn N. Byrd, MBA

President
GByrd Ad-Promo Solutions, LLC

Slides

Speaker(s)

Jennifer L. Kelley, MS, RAC

Director, Global Regulatory Affairs
Sanofi

Slides
Alan G. Minsk, Esq.

Partner & Leader, Food & Drug Practice Group
Arnall Golden Gregory, LLP

Slides Handouts

The Advertising and Promotion Regulatory landscape is one of constant change. As new, creative efforts to educate about disease and product information are developed, industry is always adjusting on how to interpret the existing regulatory framework. As new guidances are issued by OPDP/APLB, industry has to examine them and adapt them to their specific situations. Topics like Consistency with Labeling (a.k.a., CFL) are still prominent ones as well as lesser known and newer guidance-related topics like promotion of generics and biosimilars and will be discussed. This session will examine areas like CFL and generics/biosimilars promotion and provide expert commentary and examples of how to implement these in your organization.

Learning Objectives:

Assess whether or not a company promotional communication is consistent with FDA-approved labeling (CFL).
Determine acceptable criteria for the presentation of information regarding the proposed claims (appropriate evidence, context, etc.)
Describe how to move forward with a successful review, approval and dissemination of CFL promotional material.
Understand the recent FDA guidance on biosimilar promotion.
Gain knowledge of how generic promotion aligns or differs from branded promotion.