Loading...

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.

Register by August 1, 2019 and SAVE!

Industry & Firms

$499
  • +$200 for non-members
  • +$100 after 8/1/2019
  • +$100 after 9/12/2019

Non-Profit

$399
  • +$200 for non-members
  • +$100 after 8/1/2019
  • +$100 after 9/12/2019

Government

$399
  • +$200 for non-members
  • +$100 after 8/1/2019
  • +$100 after 9/12/2019

Academic

$399
  • +$200 for non-members
  • +$100 after 8/1/2019
  • +$100 after 9/12/2019

Student

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

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.

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.

Agenda

subject to change

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

12:0012:15 PM
FDLI Welcome and Announcements
Laura Brown, Director, Educational Programs, FDLI

12:15–1:15 PM
Key Principles of Advertising and Promotion
Bryant Godfrey
, Counsel, Arnold & Porter LLP

  • 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

1:15–2:15 PM
Prescription Drug and Restricted Device Promotion
Dolores Shank-Samiec
, Executive Director, Office of Advertising and Promotion Review, Merck & Co., Inc.

  • 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

2:152:30 PM
Networking and Refreshment Break

2:30–3:45 PM
Dissemination of Information About Unapproved Uses
Katlin McKelvie Backfield
, Principal, Backfield PLLC

  • 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
  • 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 Exchange and Pre-Approval Communications
  • Scientific and Educational Activities, Including Continuing Education
  • Use of Medical Science Liaisons (MSLs); Unsolicited Requests for Information by Medical Professionals

3:45–4:15 PM
Other Agencies and Considerations
Anne Maher
, 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
  • AdvaMed Code of Ethics

4:15–5:00 PM
Case Study/Hypothetical
Jessica Ringel, Counsel, King & Spalding LLP
Gillian Russell, Counsel, King & Spalding 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

5:30 PM–7:00 PM
Networking Reception
Hosted by Skadden, Arps, Slate, Meagher & Flom LLP

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.

Curriculum Advisor

The Curriculum Advisor will be announced shortly.

 

Enhance Your Career

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

Location and Overnight Accommodations coming soon. 

 

2018-11-12T09:55:19+00:00