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10/03/2015 11/03/2015 America/Toronto American Conference Institute's 24th FDA Boot Camp American Conference Institute’s 24th FDA Boot Camp
March 10 – 11, 2015
Doubletree Suites by Hilton Times Square, New York, NY
Please visit https://staging.americanconference.com/fda-boot-camp-711l15-nyc/ for more information and updates. Doubletree Suites by Hilton Times Square, New York, NY true DD/MM/YYYY 1440 use-title -
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10/03/2015 11/03/2015 America/Toronto American Conference Institute's 24th FDA Boot Camp American Conference Institute’s 24th FDA Boot Camp
March 10 – 11, 2015
Doubletree Suites by Hilton Times Square, New York, NY
Please visit https://staging.americanconference.com/fda-boot-camp-711l15-nyc/ for more information and updates. Doubletree Suites by Hilton Times Square, New York, NY true DD/MM/YYYY 1440 use-title -
Post-Approval Marketing Guidance and Preemption Protocols
1:15 Advertising and Promotion
Dale Cooke
President
PhillyCooke Consulting (Philadelphia, PA)
Advertising and Promotion Overview
- Overview of laws and regulations controlling the advertising,
marketing, and promotion of prescription drugs, biologics,
and medical devices - Office of Prescription Drug Promotion (OPDP), Advertising
and Promotional Labeling Branch (APLB) & Office of
Compliance – duties, responsibilities, and enforcement authority - Evaluating new guidance on internet promotions and use of social media
- Identifying the role of the FTC in the advertising and promotion of drugs
- Advertising requirements for prescription versus nonprescription products
- Overview of the promotional materials submission and review process
- What constitutes a launch?
- What information must a drug advertisement include?
- Exploring the role of the label in advertising and the perils of off-label promotion
Special Concerns for DTC Advertising
- How is direct-to-consumer advertising regulated and monitored?
- What information must every DTC ad contain?
- How do the PhRMA DTC guidelines interplay with current FDA regulation?
- FDA’s DTC Television User Fee Program
- Advertising and new media—how is Internet and e-mail advertising regulated?
2:30 Preemption Fundamentals
James Beck
Counsel
Reed Smith LLP (Philadelphia, PA)
- Defining express and implied preemption
- Recognizing the basis for drug and device preemption
- Uncovering how the presumption against preemption has been applied in drug and device litigation
- Recognizing the interplay between preemption and the FDA regulatory process
- Fundamental precedents: Riegel v. Medtronic and Wyeth v. Levine
- Understanding the “parallel requirements” exception to preemption
3:30 Afternoon Refreshment Break
3:45 Regulation and Dissemination of Off-Label Information
Joseph G. Poluka
Partner
Blank & Rome LLP (Philadelphia, PA)
- Overview of the FDA’s regulation of off-label promotion
- How can information on off-label or unapproved uses of drugs and biologics be disseminated?
- What are the consequences of inappropriate off-label promotion?
- Survey of recent investigations, penalties, and settlements
5:00 Master Class C Concludes