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

Highlighted Topics:

  • 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

 

venue sponsor

 

Register by July 23 and SAVE!

Industry & Firms

$499
  • +$200 for non-members
  • +$100 after 7/23/2020
  • +$100 after 9/10/2020

Non-Profit

$399
  • +$200 for non-members
  • +$100 after 7/23/2020
  • +$100 after 9/10/2020

Government

$399
  • +$200 for non-members
  • +$100 after 7/23/2020
  • +$100 after 9/10/2020

Academic

$399
  • +$200 for non-members
  • +$100 after 7/23/2020
  • +$100 after 9/10/2020

Student

$99
  • student registration
  • full-time students only
  • transcripts required
Register Now

 

Internet Explorer and Microsoft Edge are not supported by the checkout process.

Please use Chrome, Firefox, or Safari.  If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you in your purchase.

To ensure that FDLI is able to provide you with a seat, materials, and meals, please register for programs at least 48 hours in advance. While onsite registration is available on a “space-available” basis; late registrants are not guaranteed materials or meals.

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 [email protected] or 800-956-6293.

Last Year’s Agenda

 

Wednesday, October 16

11:30 AM–12:00 PM
Registration and Lunch

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

12:15–1:15 PM
Key Definitions and Applicable FDA Offices

  • Why it Matters
  • Basic Definition and Concepts of Labels, Labeling, and Advertising
  • Intended Use and the New Drug Approval Requirement
  • Misbranding
  • CDER Office of Prescription Drug Promotion (OPDP) and CBER Advertising and Promotional Labeling Branch (APLB)
  • CDRH Division of Premarket and Labeling Compliance (DPLC)

1:15–2:15 PM
Essential Concepts of Prescription Drug and Restricted Device Promotion

Here we delve into fundamental concepts of advertising and promotion. We will provide examples to help in the understanding of these concepts.

  • Basic Principles
  • Types of Advertising
  • Pre-Approval Communications
  • Traditional and Other Forums

2:15–2:30 PM
Networking and Refreshment Break

2:30–3:45 PM
Dissemination of Information About Unapproved Uses

During this session, we will explore crucial aspects of unapproved uses 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

3:45–4:15 PM
Other Agencies and Considerations

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
Case Studies/Hypotheticals

 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

 

 

 

 

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

Location and Overnight Accommodations

Conference Location

Skadden, Arps, Slate, Meagher & Flom LLP
1440 New York Ave., NW
Washington, DC 20005

Overnight Accommodations

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.