Master the essentials of advertising and promotion law and regulation for medical products, including the roles of multiple FDA offices and other agencies. Learn about the boundaries of off-label promotion and tie it together with interactive case studies. 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 Principles and Definitions;
- FDA’s Office of Prescription Drug Promotion (OPDP);
- Other Regulatory Authorities and Considerations;
- The Use of Internet and Social Media for Product Marketing;
- Off-label Communications;
- Anti-kickback Statute, False Claims Act, Product Liability, and the Lanham Act, and State Actions.
Case studies, hypotheticals, and ample time for Q&A will be provided.
Build On Your Knowledge
Add the two-day 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.
Agenda
subject to change
Curriculum Advisors
Heather Banuelos, Counsel, King & Spalding LLP
Rebecca Burnett, Exec Director and Head of Strategic Services, Framework Solutions
Virginia Foley, Principal Consultant, Opus Regulatory, Inc.
Cynthia Meyer, Partner, Kleinfeld, Kaplan & Becker, LLP
Dolores Shank-Samiec, Executive Director, Office of Promotion and Advertising Review, Merck & Co., Inc.
Wednesday, October 16
11:30 AM–12:00 PM
Registration and Lunch
12:00–12:15 PM
FDLI Welcome and Course Overview
Melissa Scales, Assistant Director, Educational Programs, FDLI
Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP, and Chair, FDLI Board of Directors
12:15–1:15 PM
Key Definitions and Applicable FDA Offices
Virginia Foley, Principal Consultant, Opus Regulatory, Inc.
- 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
Dolores Shank-Samiec, Executive Director, Office of Advertising and Promotion Review, Merck & Co., Inc.
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
Heather Banuelos, Counsel, King & Spalding LLP
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
Karen Corallo, Of Counsel, Skadden, Arps, Slate, Meagher & Flom 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
4:15–5:00 PM
Case Studies/Hypotheticals
Rebecca Burnett, Executive Director and Head of Strategic Services, 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
5:00 PM–7:00 PM
Networking Reception
Location: Skadden, Arps, Slate, Meagher & Flom LLP
1440 New York Avenue, NW, Washington, DC 20005
Thursday, October 17 –
Friday, October 18
Advertising and Promotion Conference
Add this two day conference to your registration and save $100 on the combined registration fees.
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.
Pennsylvania: approved for 4.5 CLE credit hours
Virginia: approved for 4.5 CLE credit hours
Location and Overnight Accommodations
Course Location
Skadden, Arps, Slate, Meagher & Flom LLP
1440 New York Ave NW
Washington, DC 20005
Overnight Accommodations
A block of rooms has been reserved at the Renaissance for conference attendees at the special group rate of $439/night, not inclusive of taxes. Reservations can be made online and must be received by September 25, 2019 to receive the group rate. After this date, it is at the hotel’s discretion whether to accept additional reservations, which will be subject to prevailing rates and availability.
Parking and Public Transportation
Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.
