Wednesday, October 16
11:30 AM–12:00 PM
Registration and Lunch
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
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
- CDER Office of Prescription Drug Promotion (OPDP) and CBER Advertising and Promotional Labeling Branch (APLB)
- CDRH Division of Premarket and Labeling Compliance (DPLC)
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
Networking and Refreshment Break
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