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 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.

Who Should Attend

  • New legal and regulatory professionals
  • Seasoned practitioners new to the topic or wanting a refresher

Last Year’s Agenda

subject to change

Monday, September 25

12:30–1:00 PM
Registration

1:00–1:15 PM  
FDLI Welcome and Announcements
Laura Brown, Director, Educational Programs, FDLI

1:15–2:00 PM
Key Principles of Advertising and Promotion
Cassie Scherer,
Principal Legal Counsel, Corporate Legal Regulatory, Medtronic

  • 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), formerly the Division of Drug Marketing, Advertising, and Communications (DDMAC), and CBER Advertising and Promotional Labeling Branch (APLB)
  • 510(k) Devices

2:00–2:45 PM
Prescription Drug and Restricted Device Promotion
J. Benneville (Ben) Haas
, Partner, Latham & Watkins LLP

  • Promotional Labeling vs. Advertisements
  • Fair Balance
  • Brief Summary for Advertisements
  • Broadcast Advertisements
  • Comparative Claims
  • Establishment Claims
  • Use of Internet, Electronic and Social Media
  • Disease Awareness and Help Seeking Ads

2:45–3:00 PM
Networking and Refreshment Break

3:00–3:45 PM
Dissemination of Information About Unapproved Uses
Mahnu Davar
, Partner, Arnold & Porter Kaye Scholer LLP

  • Why it Matters and What Does it Mean?
  • First Amendment Jurisprudence: Central Hudson, Washington Legal Foundation v. Henney, Caronia, and other Key Decisions
  • Key Concepts: Intended Use, Off-Label Promotion, Off-Label Use, and Practice of Medicine
  • Good Reprint Practices
  • Use of Medical Science Liaisons (MSLs); Unsolicited Requests for Information by Medical Professionals
  • Scientific Exchange and Pre-Approval Communications
  • Scientific and Educational Activities, Including Continuing Education
  • Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers
  • Medical Product Communications that are Consistent with the FDA-Required Labeling – Questions and Answers

3:45–4:15 PM
Other Agencies and Considerations
Kinsey S. Reagan
, Partner, Kleinfeld, Kaplan & Becker, LLP

  • 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

4:15–5:00 PM
Case Study/Hypothetical
James R. Ravitz, Partner, Arent Fox LLP

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
Adjournment

5:00–6:30 PM
Networking Reception
hosted by Latham & Watkins LLP

Tuesday, September 26 –
Wednesday, September 27

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, 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.