Overview

In a convenient virtual format, master the essentials of advertising and promotion law and regulation for medical products, including the roles of multiple FDA offices and other agencies. This course provides a foundation for understanding the topics that will be discussed at a more advanced-level during the Advertising and Promotion Conference.

Highlights:

  • Key Definitions and Applicable FDA Offices
  • Essential Concepts of Prescription Drug and Restricted Device Promotion
  • Dissemination of Information about Unapproved Uses
  • The Use of Internet and Social Media for Product Marketing
  • False Claims Act, Qui tam Actions, Anti-Kickback Statute
  • Product Liability, Lanham Act, and State Actions
  • Case Studies, Hypotheticals
  • Ample Time for Q&A
  • Innovative Virtual Framework

Register

Industry & Firms

$699
  • +$200 for non-members

Non-Profit

$599
  • +$200 for non-members

Government

$599
  • +$200 for non-members

Academic

$599
  • +$200 for non-members

Student

$99
  • full-time students only

A Valuable Reference In Your Preferred Format

Order FDLI’s A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th Edition, now available in e-book and print formats, for an accessible overview to the key legal and regulatory topics.

Build On Your Knowledge

Add the Advertising and Promotion for Medical Products Conference to your course registration to gain a more advanced understanding of these complex topics and save $100 off the combined fees.

You can transfer your registration to another person at your organization for no cost by notifying us of the change. If you notify FDLI in writing at least five business days prior to the meeting, you can cancel your registration for a full refund (less a $75 fee). Refunds will be applied against the original form of payment.  

Our event policies are listed here. If you should have any further questions, please contact us at in[email protected] or 800-956-6293.

Agenda

Tuesday, October 27

11:00–11:50 AM
Bonus Session: Managing Promotional Issues in a Virtual Setting

Rebecca Burnett, Executive Director, Framework Solutions
Virginia Foley, Principal Consultant, Opus Regulatory, Inc.
Michael Smith, Managing Member, Michael F. Smith Law, PLLC
Moderated by Madhavi Bellamkonda, Global Regulatory Advertising & Promotion Leader, Abbott Laboratories

 

During and even prior to the COVID-19 pandemic, various review committees and other advertising and promotion-related efforts have shifted from in-person to virtual settings. This session will focus on how to virtually conduct these promotional collaborations while maintaining the essence of in-person partnerships.

  • Why is Remote Different from an In-Person Setting?
  • Best Practices for Remote Collaboration (e.g., Medical, Legal, and Regulatory Review and Promotional Review Committees)
  • Legal Considerations

12:00–12:15 PM
Welcome and Course Overview

Laura Brown, Director, Educational Programs, FDLI
Melissa Scales, Assistant Director, Educational Programs, FDLI

12:15–1:30 PM
I. Applicable FDA Offices, Essential Principles, & Key Definitions

Virginia Foley, Principal Consultant, Opus Regulatory, Inc.
Dolores M. Shank-Samiec, Executive Director, Office of Promotion and Advertising and Review, Merck & Co., 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 
  • Types of Claims
  • Disease Awareness (Unbranded)
  • Traditional and Other Forums
  • Preapproval Communications
  • Submissions

 

1:45–3:00 PM
II. Dissemination of Information about Unapproved Uses

Heather Banuelos, 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
  • Key Concepts: Intended Use, Unapproved Use, and Practice of Medicine
  • FDA Final Guidance: Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers
  • FDA Final Guidance: Medical Product Communications that are Consistent with the FDA-Required Labeling – Questions and Answers
  • Good Reprint Practices
  • Scientific and Educational Activities, Including Continuing Education
  • Role of Medical Science Liaisons (MSLs); Unsolicited Requests for Information by Medical Professionals

3:15–4:00 PM
III. Other Agencies and Considerations

Michael Francis Smith, Managing Member, Michael F. Smith Law, PLLC

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

4:15–5:00 PM
IV. Case Studies/Hypotheticals

Rebecca Burnett, Executive Director, Framework Solutions

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.

5:00 PM
Course Adjournment

 

 

FDLI would like to thank the Curriculum Advisors for planning this Introductory Course:

Madhavi Bellamkonda, Global Regulatory Advertising & Promotion Leader, Abbott Laboratories
Rebecca Burnett, Executive Director, Framework Solutions
Mary Ellen Dronitsky, Head of Regulatory Labeling Advertising and Promotion, Arena Pharmaceuticals
Virginia Foley, Principal Consultant, Opus Regulatory, Inc.
Mike Smith, Managing Member, Michael F. Smith Law, PLLC

 

Continuing Legal Education

FDLI applies for CLE credits in Ohio and Virginia. These CLE approvals also may be honored by other states. The CLE credits will be posted as they are granted and registrants can request to be notified when approval is received.