Agenda

Subject to change
All times are in Eastern Time

2022 Curriculum Advisor:
Gillian M. Russell, Counsel, King & Spalding LLP

Tuesday, October 11

12:00–12:15 PM
Welcome and Course Overview
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:15–1:30 PM
I. Applicable FDA Offices, Essential Principles, & Key Definitions
Stephanie Jameison, Sr. Director, Global Regulatory Affairs, Promotion Compliance, Otsuka America Pharmaceutical, Inc.

In this session we will discuss the relevant FDA offices that regulate advertising and promotional labeling of medical products, including drugs and medical devices for both human and veterinary use. We will also explore essential definitions and principles of medical product advertising and promotion.

  • Why it Matters
  • FDA Offices
  • FDA Enforcement
  • Key Definitions and Essential Principles of Advertising and Promotional Labeling
  • Fundamental Principles of Compliant Promotion
  • Rules for Specific Categories of Promotion
  • Prohibition on Pre-Approval Promotion
  • Submissions

1:45–2:00 PM
Break

2:00–3:00 PM  
II. Dissemination of Non-Promotional Information
Gillian M. Russell, Counsel, King & Spalding LLP

During this session, we will explore crucial aspects of topics such as unapproved use and intended use, and the First Amendment legal decisions underlying these concepts. We will also discuss guidance documents FDA has issued on this topic, as well as special circumstances regarding dissemination of use information.

  • Why It Matters and What It Means
  • First Amendment Jurisprudence: Central Hudson, Washington Legal Foundation v. Henney, Caronia, and Other Key Decisions
  • Scientific Exchange – Pathways for Non-Promotional Communications
  • Disease Awareness
  • Role of Medical Science Liaisons (MSLs)

3:00–3:15 PM
Break

3:15–4:00 PM
III. Other Agencies and Considerations
Heather Banuelos, Counsel, King & Spalding LLP

This session will cover the other agencies and entities that govern and impact advertising and promotion of medical products.

  • Federal Trade Commission (FTC) Authority
  • National Advertising Division (NAD)
  • Interactions with SEC
  • Lanham Act
  • False Claims Act, Qui tam Actions, and Anti-Kickback Statute
  • State Actions and Consumer Class Actions
  • PhRMA Code on Interactions with Healthcare Professionals
  • AdvaMed Code of Ethics
  • Sunshine Act

4:00–4:15 PM
Break

4:15–5:15 PM
IV. Case Studies/Hypotheticals
Erin Carducci, Director, Regulatory Advertising & Promotion, Digital Strategy & Innovation, Novartis Pharmaceuticals Corporation
John Kung, Deputy Head of Legal, Customer Strategy & Engagement, Novartis Pharmaceuticals Corporation

During this session, attendees will have the opportunity to apply the advertising and promotion knowledge they have learned over the course of the day through interactive, real-life, and hypothetical examples. This interesting and engaging session will tie together concepts, authorities, and agencies that have been discussed during the course.

 

5:15 PM
Course Adjournment