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.

Venue Sponsor

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

Register by September 13 and SAVE!

Industry & Firms

$599
  • +$100 for nonmembers
  • +$100 after 9/13/18

Non-Profit

$499
  • +$100 for nonmembers
  • +$100 after 9/13/18

Government

$499
  • +$100 for nonmembers
  • +$100 after 9/13/18

Academic

$499
  • +$100 for nonmembers
  • +$100 after 9/13/18

Student

$99
  • student registration
  • 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
Registration and Lunch

12:00 PM
Welcome and Course Overview
Laura Brown, Director, Educational Programs, FDLI

12:15–1:15 PM
I. Key Principles of Advertising and Promotion

  1. Why it Matters
  2. Basic Definition and Concepts of Labels, Labeling, and Advertising
    1. Including Internet, Electronic, and Social Media
  3. Intended Use and the New Drug Approval Requirement
  4. Misbranding
    1. Adequate Directions for Use
    2. False or Misleading Labeling
    3. Material Omissions
    4. Lack of Adequate Directions or Warnings
  5. 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)
    1. Preclearance and Advisory Comments
    2. Submission Requirements
    3. Warning and Untitled Letters
    4. Corrective Actions
  6. 510(k) Devices
    1. How they differ from the above requirements
    2. CDRH Division of Premarket and Labeling Compliance (DPLC)

1:15–2:15 PM
II. Prescription Drug and Restricted Device Promotion

  1. Promotional Labeling vs. Advertisements
  2. Fair Balance
  3. Brief Summary for Advertisements
  4. Broadcast Advertisements
  5. Comparative Claims
  6. Establishment Claims
  7. Use of Internet, Electronic and Social Media
  8. Disease Awareness and Help Seeking Ads

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

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

  1. Why it Matters and What Does it Mean?
  2. First Amendment Jurisprudence: Central Hudson, Washington Legal Foundation v. Henney, Caronia, and other Key Decisions
  3. Key Concepts: Intended Use, Off-Label Promotion, Off-Label Use, and Practice of Medicine
  4. FDA Final Guidance: Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers
  5. FDA Final Guidance: Medical Product Communications that are Consistent with the FDA-Required Labeling – Questions and Answers
    1. Substantiation
    2. Data: Patient Reported Outcomes / Patient Preference Information / Real World Evidence
    3. Conformance with Approved Labeling
    4. General vs. Specific Claims
  6. Good Reprint Practices
  7. Scientific Exchange and Pre-Approval Communications
  8. Scientific and Educational Activities, Including Continuing Education
  9. Use of Medical Science Liaisons (MSLs); Unsolicited Requests for Information by Medical Professionals

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

  1. Federal Trade Commission (FTC) Authority
    1. FTC Regulation of Advertising for OTC Drugs and Devices
    2. Substantiation
  2. National Advertising Division (NAD)
    1. Case Examples: OTC and Restricted Devices
  3. Interactions with SEC
  4. Lanham Act
  5. False Claims Act, Qui tam Actions, and Anti-Kickback Statute
  6. State Actions and Consumer Class Actions
  7. PhRMA Code on Interactions with Healthcare Professionals
  8. AdvaMed Code of Ethics

4:15–5:00 PM
V. Case Study/Hypothetical

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 to explain how they play out in the real world.

5:00 PM
Course Adjournment

5:00–6:30 PM
Networking Reception
Circa
781 7th St NW, Washington, DC 20001
Sponsored by Skadden Arps

Tuesday, October 16 –
Wednesday, October 17

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.

Conference Location

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

Driving, Parking, and Public Transportation 

Skadden Arps is a short distance from the Metro Center metro station on the blue, orange, red, and silver lines. Parking is available in the garage at 1420 New York Ave., which is in the Skadden building. There are several other public garages nearby.

Overnight Accommodations

A block of rooms has been reserved at the Renaissance for conference attendees. Reservations can be made online. The group rate is $349/night. Reservations must be received by September 13, 2018 to receive the group rate. After this date, rooms will be subject to prevailing rates and availability.

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

2018-08-17T12:56:56+00:00